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	<title>SAFC Live – Blog on Biotech, Biopharma and Life Sciences</title>
	<atom:link href="http://safclive.com/feed/" rel="self" type="application/rss+xml" />
	<link>http://safclive.com</link>
	<description>SAFC Live is a Social Media Hub and Blog covering the latest news and trends in the Biotech, Biopharma and Life Science Industries</description>
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		<title>SAFC&#8217;s Dave Backer Discusses the Full Line of SAFC PharmaGrade Products and Highlights the PharmaGrade MSX Product Capabilities</title>
		<link>http://safclive.com/safcs-dave-backer-discusses-the-full-line-of-safc-pharmagrade-products-and-highlights-the-pharmagrade-msx-product-capabilities/</link>
		<comments>http://safclive.com/safcs-dave-backer-discusses-the-full-line-of-safc-pharmagrade-products-and-highlights-the-pharmagrade-msx-product-capabilities/#comments</comments>
		<pubDate>Fri, 03 Feb 2012 19:24:26 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[Cell biology]]></category>
		<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Fine Chemicals]]></category>
		<category><![CDATA[Industry Overview]]></category>
		<category><![CDATA[Quality]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Supply Chain]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=778</guid>
		<description><![CDATA[As SAFC continues to settle into 2012, there is plenty of planning and development going on across the global SAFC network. Leading into the first big tradeshow of the year, Informex 2012 in New Orleans, LA, SAFC has been focused on introducing a new line of products that take quality and security of supply chain [...]]]></description>
			<content:encoded><![CDATA[<p>As SAFC continues to settle into 2012, there is plenty of planning and development going on across the global SAFC network. Leading into the first big tradeshow of the year, <a href="http://bit.ly/wlw35q"><strong>Informex 2012</strong></a> in New Orleans, LA, SAFC has been focused on introducing a new line of products that take quality and security of supply chain to another level. Below, <strong>Dave Backer, SAFC Director of Business Development and Marketing</strong>, discusses what the <a href="http://bit.ly/xaHRoj"><strong>PharmaGrade</strong></a><strong> </strong>product portfolio, means for SAFC customers and why it is relevant to the market.</p>
<p><strong><span id="more-778"></span></strong></p>
<p><strong>What was the backdrop that led to the new PharmaGrade for raw materials?</strong></p>
<p>We have been supplying raw materials to the life sciences market for many years, and as time has gone on, two things have occurred. First, there has been more and more activity on the biopharma side of the market compared to traditional small molecules, and with this there is a growing need to understand the entire supply chain, and ensure traceability, with all the inputs meeting the necessary standards. The manufacturing process uses live organisms, whether microbes or cells, with chemicals being added to the mix to help them grow. It’s important to ensure all these components meet the necessary standards from a purity standpoint and with appropriate traceability. Regulators are pushing for greater accountability, not just for the final product, but pushing further and further back into the raw material stream.</p>
<p>The other pressure point is that companies are looking to consolidate their supply chains – if a small set of suppliers can be trusted to provide an increasing share of the materials they need for manufacturing, it is beneficial in terms of controlling costs. At SAFC, we believe we are in a pretty good position to be a primary supplier, and give our customers the transparency of supply chain that they need.</p>
<p><strong>How does this translate into the different grades of material you offer?</strong></p>
<p>Well, we needed to make sure that the research products that Sigma-Aldrich is well known for were indeed being used for research purposes, and those products being used in biopharma applications have the appropriate quality standards and documentation behind them. So we developed the Enhanced Quality Program that segments our supply chain into different grades – standard, premium, elite and GMP/Compendia – with increasing levels of quality, documentation and supply chain traceability. From this starting point we evolved the PharmaGrade products, building on the quality aspects of the Enhanced Quality Program to add a further level of traceability. All our sites now follow Sigma-Aldrich’s Enhanced Quality Program – some sites manufacture GMP final products that meet Q7A guidelines, while others make products that are only appropriate for research.</p>
<p><strong>So it’s important to know exactly what customers will be doing with materials they are sourcing from you?</strong></p>
<p>It is, yes. For starters, there is no need to put the huge cost of added quality on to materials that are being used in a lab research setting. They will still come with a certificate of analysis, and the fact that they have passed through a couple of different suppliers’ hands will not change how it is used. But when you get into bioproduction, full traceability is essential, so some of these products are not appropriate. The PharmaGrade name indicates to customers that the product will have full traceability right back to the manufacturer of record, and will have a documentation dossier available up front – we won’t have to go and chase it down if they require it. Premium grade is, effectively, standard grade to which we have added some traceability, but we do not go all the way back to the original manufacturer, and there is no need for validation. These are suitable for the diagnostics market from a regulatory standpoint, but it’s the Elite and GMP products that are more appropriate for pharma and biopharma.</p>
<p><strong>What do PharmaGrade products have that sets them apart?</strong></p>
<p>It is our way of saying that, for biopharma or pharma production, here is the portfolio of products that are ‘fit for use’ from a manufacturing, quality, and supply chain perspective. Within the biopharma space, excluding commodity products like salts and sugars, there are probably only about 300 chemicals that need to be at this really high level of specifications. Some are used in the media that we make; some are used on their own as supplements, reagents, or base chemicals.</p>
<p>There are also products like L-Methionine sulfoximine, or MSX, which helps in the selection of an appropriate cell line by knocking out those cells that do not have the ability to produce a certain enzyme, thus increasing the quality of the resulting cell line. A small amount of this chemical may be used when creating a cell bank, but it is like liquid gold in ensuring the final cell line is appropriately selected. The cost of failure is huge here, as it’s the master bank for a production process. It might be developed when a product is in Phase I, and then used all the way through to commercial production. So if there is a problem with the cell bank every single batch will be affected.</p>
<p>MSX is difficult to make, and we worked hard to develop the product at our manufacturing facility in Buchs, Switzerland. It is made in a well-controlled environment, and several customers are interested in the product as it removes a critical risk point for them. This is the type of product that we will include in the PharmaGrade portfolio. We want customers to be able to say that they know our quality systems are appropriate and sufficiently robust, and not throw up unexpected concerns five or even 10 years down the line.</p>
<p><strong>Is this something customers have been asking for, or something SAFC has been proactive about offering them?</strong></p>
<p>It is a bit of both. Certainly, there have been requests over the years, and we carried out a substantial survey of the marketplace and our customers to find out what they required. We are not in the commodity business, so we’re not offering bulk salts and sugars in this portfolio, but focusing on those chemicals required in the biopharma manufacturing space that are used in smaller quantities and need that high quality and high level of supply chain transparency. We have worked directly with customers to solve their risk points, and this has led to some products being added to the portfolio, where a handful of customers were asking for the same thing, such as MSX. By offering it in pre-packed containers to different clients this reduces the cost to each of them.</p>
<p><strong>What’s the uptake been like since you launched the PharmaGrade name in January?</strong></p>
<p>It has been pretty significant. We have already been talking to some of our larger customers about it, and there are now about 50 products available in this grade, with more to be added throughout the year. We are very excited about the program, and how it can help our customers. We anticipate that people will see the product list, and ask for others to be added to it. This is already happening – quite often these are products we are already working on, but we’ve already had a couple suggested that we had not thought of. I am very pleased with the response we have had from customers.</p>
<p>SAFC staff will be onsite daily throughout Informex 2012 as an exhibitor and sponsor of the <a href="http://www.informex.com/networking-lounge">Informex Networking Lounge</a>. To learn more about the <a href="http://bit.ly/xaHRoj">PharmaGrade line</a>, please visit <a href="http://bit.ly/q40gKU">Booth 1600</a> or <a href="http://bit.ly/xaHRoj">click here</a>.</p>
<p>SAFC has also put together technical papers covering various technologies and industry issues, such as the <a href="http://www.safcglobal.com/safc-global/en-us/home/white-papers/ipec-guidelines.html">IPEC Guidelines</a>. Access the full list by <a href="http://safc.sigmaaldrich.com/g/?S32NV7K7NW">clicking here</a>.</p>
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		<title>BREAKING NEWS: BioReliance to Become Part of SAFC</title>
		<link>http://safclive.com/breaking-news-bioreliance-to-become-part-of-safc/</link>
		<comments>http://safclive.com/breaking-news-bioreliance-to-become-part-of-safc/#comments</comments>
		<pubDate>Wed, 01 Feb 2012 00:03:13 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[biology]]></category>
		<category><![CDATA[Bioprocessing]]></category>
		<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Fine Chemicals]]></category>
		<category><![CDATA[Industry Overview]]></category>
		<category><![CDATA[Media Production]]></category>
		<category><![CDATA[Quality]]></category>
		<category><![CDATA[Regulatory]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=772</guid>
		<description><![CDATA[&#160; Today, Sigma Aldrich confirmed that the newly acquired BioReliance business will become part of SAFC, the custom manufacturing and services business unit of Sigma-Aldrich. SAFC President, Gilles Cottier noted that the acquisition would serve to increase the SAFC value proposition and positively leverage the company&#8217;s industrial media presence and biological testing capabilities for end [...]]]></description>
			<content:encoded><![CDATA[<p>&nbsp;</p>
<p>Today, Sigma Aldrich confirmed that the newly acquired BioReliance business will become part of SAFC, the custom manufacturing and services business unit of Sigma-Aldrich. SAFC President, Gilles Cottier noted that the acquisition would serve to increase the SAFC value proposition and positively leverage the company&#8217;s industrial media presence and biological testing capabilities for end user services and solutions.</p>
<p><span id="more-772"></span></p>
<p><strong>Sigma-Aldrich Completes Acquisition of BioReliance</strong></p>
<p><strong>St. Louis, MO – January 31, 2012 <em>– <a href="http://www.sigmaaldrich.com/">Sigma-Aldrich </a></em></strong>Corporation (NASDAQ:SIAL), a leading Life Science and High Technology company, announced it has completed its acquisition of BioReliance Holdings, Inc., a leading provider of global biopharmaceutical testing services, from Avista Capital Partners for $350 million in cash, subject to normal post-closing adjustments.</p>
<p>BioReliance provides critical services that include biologic, specialized toxicology and animal health testing to pharmaceutical, biopharmaceutical, diagnostics, and other life science customers worldwide. As a leading provider of biological safety testing, its service offering helps facilitate the development, manufacturing and commercialization of biological drugs and helps enable its clients to register their products worldwide. As a service provider of toxicology studies, BioReliance also enables its clients to launch new small molecule drugs worldwide. BioReliance employs over 650 people and is headquartered in Rockville, Maryland, with additional operations in Glasgow and Stirling, Scotland and sales offices in Tokyo, Japan and Bangalore, India.</p>
<p>“BioReliance’s global biopharmaceutical testing services will enable Sigma-Aldrich to build a specialized services platform that complements our existing products and technology strengths. It will expand our participation in the fast growing biological drug market and will help forge deeper and stronger strategic ties with existing and new customers,” said Rakesh Sachdev, President and CEO.</p>
<p>BioReliance will become part of SAFC, the custom manufacturing and services business unit of Sigma-Aldrich. Gilles Cottier, SAFC President commented, “The combination of BioReliance and SAFC provides a richer value proposition for the development and manufacture of biological drugs. By leveraging SAFC’s industrial media presence and BioReliance’s biological testing services, we can provide new and better end-to-end product solutions and services to our biopharmaceutical customers. The alliance also provides an opportunity to leverage our CompoZr® zinc finger nuclease (ZFN) technology with BioReliance’s Toxicology and Animal Health Services operations for the development of new assays, cell lines and animal models for the Research marketplace.”</p>
<p>BioReliance generated revenues of approximately $110 million in the year ended December 31, 2010 with double-digit growth expected in 2011. The acquisition is expected to be modestly accretive to Sigma-Aldrich’s diluted earnings per share in 2012. Sigma-Aldrich funded the acquisition with a combination of existing cash and credit facilities.</p>
<p>To learn more about SAFC products and services, please <a href="http://www.safcglobal.com/safc-global/en-us/home.html">click here</a>.</p>
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		<title>SAFC Featured in the Informex 2012 Blog</title>
		<link>http://safclive.com/check-out-a-blog-featuring-safc-activity-at-informex-2012-here/</link>
		<comments>http://safclive.com/check-out-a-blog-featuring-safc-activity-at-informex-2012-here/#comments</comments>
		<pubDate>Fri, 27 Jan 2012 22:10:28 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Continuous Processing - Microreators]]></category>
		<category><![CDATA[Fine Chemicals]]></category>
		<category><![CDATA[Industry Overview]]></category>
		<category><![CDATA[Media Production]]></category>
		<category><![CDATA[Quality]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Solid State Chemistry]]></category>
		<category><![CDATA[Supply Chain]]></category>
		<category><![CDATA[Technologies]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=766</guid>
		<description><![CDATA[SAFC Marketing Manager, Nick Johnson, talks about what SAFC is bringing to the &#8220;Big Easy&#8221; in 2012 and why Informex is a key annual event for SAFC. Please click here to read the full blog. We hope to see you at Informex 2012! Come visit us at booth 1600, or to learn more about SAFC [...]]]></description>
			<content:encoded><![CDATA[<p>SAFC Marketing Manager, Nick Johnson, talks about what SAFC is bringing to the &#8220;Big Easy&#8221; in 2012 and why Informex is a key annual event for SAFC. Please <a href="http://bit.ly/wgzz3n">click here</a> to read the full blog.</p>
<p><span id="more-766"></span></p>
<p>We hope to see you at Informex 2012! Come visit us at booth 1600, or to learn more about SAFC at Informex, please <a href="http://safc.sigmaaldrich.com/g/?YZ5V5PJWBJ=clicksrc:Informex2012   ">click here</a>.</p>
<p>SAFC will also host the Informex Networking Lounge. Learn about the activities in the lounge by <a href="http://www.informex.com/networking-lounge">viewing the schedule.</a></p>
<p>To read about SAFC technology and services, please <a href="http://safc.sigmaaldrich.com/g/?S32NV7K7NW">click here</a>.</p>
<p>To join the SAFC LinkedIn Group, please <a href="http://www.linkedin.com/groupsDirectory?itemaction=mclk&amp;anetid=2756992&amp;impid=&amp;pgkey=anet_search_results&amp;actpref=anetsrch_name&amp;trk=anetsrch_name&amp;goback=.gdr_1327702170716_1">click here</a>.</p>
]]></content:encoded>
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		<title>SAFC Gets Ready to Take on the &#8220;Big Easy&#8221; at Informex 2012!</title>
		<link>http://safclive.com/safc-gets-ready-to-take-on-the-big-easy-at-informex-2012/</link>
		<comments>http://safclive.com/safc-gets-ready-to-take-on-the-big-easy-at-informex-2012/#comments</comments>
		<pubDate>Tue, 24 Jan 2012 20:47:12 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Continuous Processing - Microreators]]></category>
		<category><![CDATA[Fine Chemicals]]></category>
		<category><![CDATA[Industry Overview]]></category>
		<category><![CDATA[Quality]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Solid State Chemistry]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=761</guid>
		<description><![CDATA[SAFC wasted no time moving forward in 2012! As we ramp up for our first big show of the year, Informex 2012, we wanted to take some time to run through what we will have to offer leading up to and throughout the upcoming event in New Orleans, LA. SAFC staff and executives will be [...]]]></description>
			<content:encoded><![CDATA[<p>SAFC wasted no time moving forward in 2012! As we ramp up for our first big show of the year, Informex 2012, we wanted to take some time to run through what we will have to offer leading up to and throughout the upcoming event in New Orleans, LA.</p>
<p><span id="more-761"></span></p>
<p>SAFC staff and executives will be onsite to participate in Informex 2012 which runs from February 15th to 17th at the Morial Convention Center. The event returns to New Orleans in 2012 as a global platform for exhibitors and attendees to gain a direct view of what is happening across the various sectors within the fine and specialty chemicals and pharma markets. While in New Orleans, visitors to Informex will have the opportunity to connect with a diverse group of professionals ranging from independent companies all the way up to big Pharma in both established and emerging markets across the globe.</p>
<p>As an exhibitor and sponsor of Informex 2012, SAFC has a full line up of activity in New Orleans. We are looking forward to participating with the community and meeting and networking with new business partners. It will be a busy week and we are excited to highlight some of our activity:</p>
<ul>
<li><strong>Habitat for Humanity on Tuesday, 2/14 (all day event starting at 9am): </strong>SAFC will participate with Rx-360 in a Habitat for Humanity home-building project to support the concept of &#8220;doing well while doing good&#8221; in New Orleans.</li>
<li><strong>Panel Discussion on Wednesday, 2/15 at 7:30am: <strong>&#8220;</strong></strong><strong>Risks to the pharmaceutical Supply Chain: Can Rx-360 Help?&#8221;</strong> (<a href="http://rx-360.org/" target="_blank">View Rx-360</a>) &#8211; The Worldwide Pharmaceutical Supply Chain continues to face threats as a result of counterfeiting, adulteration, theft, and diversion which reduce the safety and efficacy of the drugs in the consumer’s medicine cabinet. <em>Tom Beil, SAFC Vice President of Quality &amp; Regulatory Affairs</em>, and Rx-360 Board Member, will participate in this panel that will discuss supply chain risks, the severity of the problem, and steps being taken by regulators and industry to mitigate these risks. <em>Located in Hall H, Room 261</em></li>
<li><strong>Tech Talks Presentation on Thursday, 2/16 at 2:30pm: </strong><strong>&#8220;Structure &amp; Property Optimization of Cocrystal Phases&#8221; &#8211; </strong>Prof. Chris Frampton, Chief Scientific Officer of SAFC Pharmorphix will present at the Elsevier Tech Talks on the structure and property optimization of Cocrystal Phases. <em>Located at Booth #950</em></li>
</ul>
<p>But that is not all! SAFC is also the official sponsor of the Informex Networking Lounge in 2012. The Lounge returns after a successful debut last year in Charlotte, NC, to act as a location to meet, network and learn throughout the show. The Networking Lounge also features educational sessions on how to maximize social media for your business, as well as a Speed Networking Session on Wednesday and Thursday featuring speed meet and greets within targeted groups for the pharma and chemicals industry.</p>
<p>To learn more about the Networking Lounge and the Speed Networking schedule, please <a href="http://www.informex.com/networking-lounge">click here</a>.</p>
<p>To learn more about SAFC at Informex, <a href="http://safc.sigmaaldrich.com/g/?YZ5V5PJWBJ">click here</a>.</p>
<p>To read more about SAFC technologies and industry insights, <a href="http://safc.sigmaaldrich.com/g/?S32NV7K7NW">click here</a>.</p>
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		<title>Rx-360 Gives Back to the Community and Makes an Impact on Quality at Informex 2012</title>
		<link>http://safclive.com/rx-360-gives-back-to-the-community-and-makes-an-impact-on-quality-at-informex-2012/</link>
		<comments>http://safclive.com/rx-360-gives-back-to-the-community-and-makes-an-impact-on-quality-at-informex-2012/#comments</comments>
		<pubDate>Thu, 19 Jan 2012 19:14:05 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[Industry Overview]]></category>
		<category><![CDATA[Quality]]></category>
		<category><![CDATA[Supply Chain]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=754</guid>
		<description><![CDATA[On Tuesday, February 14th, one day before the Informex 2012 show starts, Rx-360 will kick off their attendance at the event in New Orleans by partnering with Habitat for Humanity for one full day. Current and prospective members will be onsite in New Orleans and will work with the non-profit organization to help build a [...]]]></description>
			<content:encoded><![CDATA[<p>On Tuesday, February 14th, one day before the Informex 2012 show starts, Rx-360 will kick off their attendance at the event in New Orleans by partnering with Habitat for Humanity for one full day. Current and prospective members will be onsite in New Orleans and will work with the non-profit organization to help build a home for a family in need, as well as to promote the motto of &#8220;doing well while doing good&#8221;.</p>
<p><span id="more-754"></span></p>
<p>Habitat for Humanity is a non-profit organization that has helped build more than 500,000 decent, affordable houses around the world. The organization seeks to eliminate poverty housing and homelessness from the world, and to make decent shelter a matter of conscience and action. The approach to housing these individuals and families is unique; prospective homeowners must apply for an affordable loan program in order to get their housing request approved. Once approved, the prospective homeowner dedicates hundreds of man hours that go towards the balance of their home, as well as helping to build homes for others in the program.</p>
<p>Rx-360 chose to begin their week at Informex 2012, hosted from February 15th to 17th at the Morial Convention Center in New Orleans, Louisiana, with Habitat for Humanity because it reflects the Rx-360 format and mission. The global quality consortium is run by a group of professionals across the world that has volunteered to come together and find a way to address serious issues in the industry. For Rx-360, the significant issue is finding a way to secure the supply chain and ensure quality of pharmaceutical ingredients globally.</p>
<p>Rx-360, will exhibit at Informex 2012 in booth 2134 and have also partnered with Informex to offer a morning panel session, titled “Risks to the Pharmaceutical Supply Chain; Can Rx-360 Help?” on February 15th from 7:30 – 9:00am in Hall H, Room 261. The free session will feature Rx-360 panel members and industry executives discussing ways to face counterfeiting, quality issues and supply chain breakdowns and how this non profit group can act as a resource and business partner. Through panel sessions such as this, Rx-360 is looking to provide the greater industry with a comprehensive understanding of the risks facing the chemical and pharmaceutical supply chains and how to overcome them so that patients are protected and everyone in the industry comes out ahead.</p>
<p>High level panelists Katherine Eban, author of <span style="text-decoration: underline;">Dangerous Doses</span>;  Michael Levy, FDA; Gabrielle Cosel, Pew Health Group; Brian Johnson, Pfizer;<strong> </strong>Tom Beil, SAFC and Martin VanTrieste, Amgen will all be onsite to discuss what the risks to the supply chain are, the severity of the problem, and steps being taken by regulators and the industry to mitigate these risks. The panel will address the key topics in discussion format and close with a question and answer session. Moderator Scott Watson of AMPAC Fine Chemicals will be on hand to keep the session running smoothly, as well as to facilitate any follow-up needed.  More information about the session and the panel members can be found at <a href="../../AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/Local%20Settings/Temporary%20Internet%20Files/Informex%20-%20UBM/Show%20Daily%202012/www.informex.com/rx-360">www.informex.com/rx-360</a>.</p>
<p>To find out more about the Rx-360 consortium, please visit <a href="http://www.rx-360.org/">http://www.rx-360.org</a>.</p>
<p>To find out more about SAFC at Informex 2012, please <a href="http://bit.ly/wlw35q">click here</a>.</p>
<p>To read more about Joint Audit and Regulations, please <a href="http://safc.sigmaaldrich.com/g/?S32NV7K7NW=clicksrc:Informex2012 ">click here. </a></p>
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		<title>Hot Off the Press: Sigma-Aldrich to Acquire BioReliance in Order to Extend into Biopharmaceutical Testing and Services</title>
		<link>http://safclive.com/hot-off-the-press-sigma-aldrich-to-acquire-bioreliance-in-order-to-extend-into-biopharmaceutical-testing-and-services/</link>
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		<pubDate>Mon, 09 Jan 2012 17:18:50 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[Bioprocessing]]></category>
		<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Industry Overview]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=750</guid>
		<description><![CDATA[Today, Sigma-Aldrich Corporation announced plans to acquire BioReliance Holdings for $350M. The acquisition is part of a strategic plan to extend the company&#8217;s biopharmaceutical testing and services and increase their value proposition to customers. The extension of these services will allow Sigma-Aldrich to more effectively provide enhanced solutions for its biopharmaceutical customers and also allows [...]]]></description>
			<content:encoded><![CDATA[<p>Today, Sigma-Aldrich Corporation announced plans to acquire BioReliance Holdings for $350M. The acquisition is part of a strategic plan to extend the company&#8217;s biopharmaceutical testing and services and increase their value proposition to customers. The extension of these services will allow Sigma-Aldrich to more effectively provide enhanced solutions for its biopharmaceutical customers and also allows customers to work with a single point provider that is more vertically integrated throughout the drug discovery process. The full press release is available by clicking below. Stay tuned to SAFC Live as we provide updates on this new acquisition and what it means for the company and the industry.</p>
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<p><strong>St. Louis, MO – January 9, 2012 <em>– </em></strong>Sigma-Aldrich Corporation (NASDAQ:SIAL), a leading Life Science and High Technology company, announced it has signed an agreement to acquire BioReliance Holdings, Inc., a leading provider of global biopharmaceutical testing services, from Avista Capital Partners for $350 million in cash. The acquisition is subject to customary closing conditions, including regulatory clearance, and is expected to close in the first quarter of 2012.</p>
<p>BioReliance provides critical services that include biologic, specialized toxicology and animal health testing to pharmaceutical, biopharmaceutical, diagnostics, and other life science customers worldwide. BioReliance’s service offering helps facilitate biological drug development, manufacturing and commercialization activities. The Company&#8217;s ability to develop and execute global testing protocols in compliance with various regulatory standards enables BioReliance&#8217;s clients to register products worldwide. The addition of these services is expected to result in a broader and richer value proposition for Sigma-Aldrich and have an immediate impact on its ability to provide enhanced solutions for its biopharmaceutical customers. The advantage for the customer is the ability to work with a single point provider that is more vertically integrated throughout the drug discovery process.</p>
<p>BioReliance generated revenues of approximately $110 million in the year ended December 31, 2010 with double-digit growth expected in 2011. The acquisition is expected to be modestly accretive to Sigma-Aldrich’s diluted EPS in 2012 and enhance its already strong free cash flow. BioReliance is headquartered in Rockville, Maryland with additional operations in Glasgow and Stirling, Scotland and sales offices in Tokyo and Bangalore. It employs over 650 people worldwide.</p>
<p>Commenting on the acquisition, President and CEO Rakesh Sachdev stated, “Our vision for Sigma- Aldrich is to enhance our Company’s broad product offering and strong technology platforms with a compelling and specialized services platform. The addition of BioReliance’s industry-leading QA/QC testing services enables us to support customers’ needs to determine the quality and integrity of biological drugs at every step of the development and manufacturing process.  As the market continues its focus on biological drug development, our leadership in this area should enable us to build even better, more customer-specific solutions. We are excited to add BioReliance’s capabilities and its talented employees to our Company and fully expect its addition to contribute to our long-term growth and return goals.”</p>
<p>Sigma-Aldrich expects to fund the acquisition with a combination of existing cash and credit facilities.  Morgan Stanley &amp; Co. LLC acted as financial advisor and Bryan Cave LLP served as legal advisor to Sigma-Aldrich for this transaction.</p>
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<p>For more information about Sigma-Aldrich products and services, please <a href="http://www.sigmaaldrich.com/united-states.html?cm_mmc=Google_eBusiness-_-search-_-SIAL+Countries_Countries-_-sigma+aldrich+united+states_Broad&amp;cm_guid=1-_-100000000000000025835-_-7408517799">click here</a>.</p>
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		<title>SAFC Welcomes the New Year with an Industry Perspective from President, Gilles Cottier</title>
		<link>http://safclive.com/safc-welcomes-the-new-year-with-an-industry-perspective-from-president-gilles-cottier/</link>
		<comments>http://safclive.com/safc-welcomes-the-new-year-with-an-industry-perspective-from-president-gilles-cottier/#comments</comments>
		<pubDate>Fri, 06 Jan 2012 19:30:04 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Industry Overview]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=746</guid>
		<description><![CDATA[SAFC Live wishes you a Happy New Year! As we head into 2012, we are excited to kick off the year with a featured industry piece from our President, Gilles Cottier in Pharmaceutical Technology. Click here to read Gilles’ perspective on challenges facing the industry and emerging trends. Throughout the year, SAFC Live will continue [...]]]></description>
			<content:encoded><![CDATA[<p>SAFC Live wishes you a Happy New Year!</p>
<p>As we head into 2012, we are excited to kick off the year with a featured industry piece from our President, Gilles Cottier in Pharmaceutical Technology. <a href="http://pharmtech.findpharma.com/pharmtech/Outsourcing/QampA-with-Gilles-Cottier-SAFC/ArticleStandard/Article/detail/754387?contextCategoryId=48562">Click here</a> to read Gilles’ perspective on challenges facing the industry and emerging trends. Throughout the year, SAFC Live will continue to post exclusive content, editorial links and industry insight for you to reference.</p>
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		<title>SAFC Featured in Year-End Industry Reviews and a Comprehensive View of the Chemical Industry</title>
		<link>http://safclive.com/safc-featured-in-year-end-industry-reviews-and-a-comprehensive-view-of-the-chemical-industry-overall/</link>
		<comments>http://safclive.com/safc-featured-in-year-end-industry-reviews-and-a-comprehensive-view-of-the-chemical-industry-overall/#comments</comments>
		<pubDate>Fri, 30 Dec 2011 21:28:54 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[APIs]]></category>
		<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Industry Overview]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=741</guid>
		<description><![CDATA[2011 is quickly coming to a close. As the year wraps up, SAFC has been featured in a few year-end industry review articles that we are pleased to be a part of and wanted to share. In-Pharmatechnologist rated SAFC&#8217;s Glasgow Conference as #8 in the top 10 API related developments of 2011. The conference was [...]]]></description>
			<content:encoded><![CDATA[<p>2011 is quickly coming to a close. As the year wraps up, SAFC has been featured in a few year-end industry review articles that we are pleased to be a part of and wanted to share.</p>
<p>In-Pharmatechnologist rated <em><a href="http://www.in-pharmatechnologist.com/Materials-Formulation/Round-up-of-SAFC-s-Glasgow-conference">SAFC&#8217;s Glasgow Conference</a> as </em>#8 in the top 10 API related developments of 2011. The conference was held in September of 2011 and featured a multi-day conference and SAFC Irvine facility tour.</p>
<p>Speciality Chemicals featured SAFC President, Gilles Cottier in a round-up piece, titled <em><a href="http://www.specchemonline.com/articles/view/fine-outlook-in-frankfurt">Fine Outlook in Frankfurt</a>, </em>that highlighted the recent CPhI Worldwide events in Frankfurt, Germany.</p>
<p>As a complement to these stories, The American Chemistry Council (ACC) has created a comprehensive year end review of the global chemicals industry as a whole in 2011 that is full of market information. Please <a href="4624.cleverreach.de/c/4670660/6aa67a32532e.">click here</a> to read.</p>
<p>SAFC Live would like to thank you for time and readership throughout 2011 and we look forward to seeing you here often in 2012!</p>
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		<title>SAFC Lives: Rod Kelley, VP of Life Science Manufacturing at SAFC</title>
		<link>http://safclive.com/safc-lives-rod-kelley-vp-of-life-science-manufacturing-at-safc/</link>
		<comments>http://safclive.com/safc-lives-rod-kelley-vp-of-life-science-manufacturing-at-safc/#comments</comments>
		<pubDate>Mon, 12 Dec 2011 20:00:44 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Industry Overview]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=735</guid>
		<description><![CDATA[SAFC Lives presents personnel profiles where we talk to the people and personalities who make SAFC tick, and find out something about their work, what drives them, their aspirations, and what they enjoy doing when they’re not playing a critical role in the ongoing growth of SAFC. In this edition, we talk with Rod Kelley, [...]]]></description>
			<content:encoded><![CDATA[<div id="attachment_738" class="wp-caption alignright" style="width: 160px"><a href="http://safclive.com/wp-content/uploads/2011/12/Rod-Kelley.jpg"><img class="size-thumbnail wp-image-738" title="Rod Kelley" src="http://safclive.com/wp-content/uploads/2011/12/Rod-Kelley-150x150.jpg" alt="" width="150" height="150" /></a><p class="wp-caption-text">Rod Kelley, VP of Life Sciences Manufacturing at SAFC</p></div>
<p>SAFC Lives presents personnel profiles where we talk to the people and personalities who make SAFC tick, and find out something about their work, what drives them, their aspirations, and what they enjoy doing when they’re not playing a critical role in the ongoing growth of SAFC.</p>
<p>In this edition, we talk with <strong>Rod Kelley, VP of Life Science Manufacturing at SAFC</strong>, who is based in Lenexa, Kansas.</p>
<p><span id="more-735"></span><strong>SAFC Live: </strong>Hello Rod. Please start us off with a background of your position and an idea of what your day to day duties are.</p>
<p>My job title was recently changed to Vice President of Life Sciences Manufacturing. This entailed redirecting my role towards overseeing all of the pharmaceutical manufacturing facilities that SAFC operates. In simple terms, I make sure that all the manufacturing sites that support the SAFC life sciences business are properly staffed, resourced and prepared to deliver cost effective products that meet or exceed expectations.</p>
<p><strong>SAFC Live: </strong>How long have you been with SAFC?</p>
<p>I have been with Sigma Aldrich for a total of twenty years, with the past six years in the SAFC branch of the business. I was actually one of the first corporate employees to be hired into Sigma Aldrich. At that time, I came on board as the Director of Safety and Environmental Affairs. This job was created to re-evaluate the safety and environmental responsibility program that was in place. Sigma Aldrich was looking to make this program more effective, and because of that I really got to start at ground zero to build a new safety and environmental program. It was a unique and challenging opportunity that took advantage of my previous experience with Marion Merrill Dow (MMD) in a similar role. MMD was an ethical pharma company and I was involved in the safety and environmental programs there.</p>
<p>Over my years with Sigma Aldrich, and now SAFC, I have assumed responsibilities for many different regulated parts of the business including safety, health, compliance, regulations and some exposure to legal. In early 2000, I took over the Quality and Safety Divisions where I oversaw all quality and safety initiatives for the SAFC Biosciences business. In 2005 I became President of SAFC Biosciences and in Q4 of 2011 my role expanded into VP of Life Sciences Manufacturing for the SAFC Pharma business.</p>
<p><strong>SAFC Live: </strong>How did you enter into a career with Sigma-Aldrich?  What were the factors in this?</p>
<p>As I mentioned, during my time with MMD I was responsible for a similar program to the one SAFC was looking to roll out. I was recruited by a headhunter into my original role with Sigma Aldrich based on this background and had actually never heard of the company prior to that call.</p>
<p><strong>SAFC Live: </strong>What has inspired you during your career with Sigma? What gets you out of bed in the morning?</p>
<p>There are many things that inspire me with this company, but two things stand out the most:</p>
<p>One is looking at the underlying premise of Sigma Aldrich as a company. We have been able to participate in facilitating other companies to improve the quality of life for people. Sigma Aldrich and SAFC support so many companies with science and products that drastically impact the daily lives and health of people across the globe.</p>
<p>The other thing that inspires me is that Sigma Aldrich and SAFC truly invest in their employees. During my time here, I have personally been allowed a lot of growth and movement and that is an approach that the company takes across the board. How often is it that you can come to a company in a role in safety and move into overseeing a global manufacturing organization? At this company, you are not bound by background or education; the only thing you are bound by is your own mind, your own drive and your own desires. If you perform and you show initiative, they will give you the upward mobility and freedom to grow.</p>
<p><strong>SAFC Live: </strong>What does the “Feel It” campaign mean to you?</p>
<p>&#8220;Feel it&#8221; is going beyond just an idea or a campaign. It is sending that message that SAFC has the vision and the products that generate a real difference and this difference generates a feeling. After all, feelings are result of an external stimulus; something that makes an impact and causes a reaction which creates a thought and a feeling inside of a person. The SAFC stimulus is working to solve problems with our customers. It is an interactive approach where we look beyond selling something to a client; we look to understand their needs and their future goals and then cater to those in the most effective and efficient way possible. SAFC is a partner to our customers. We are an entity that makes our customers feel something different. This is encapsulated in the way the way we conduct business on a daily basis. We show our customers that we want to work with them and as a result, they &#8220;Feel it&#8221;. &#8220;It&#8221; is the SAFC difference.</p>
<p><strong>SAFC Live: </strong>How do you think SAFC solves problems for customers?</p>
<p>What stands out for me personally is our approach, and I believe this resonates with the customers, as well. SAFC does not try to walk in the door with a catalogue of products and just sell. Our approach is to walk in the door, sit down, ask questions and try to understand what our customers&#8217; challenges are before we do anything else. Then we look at applying our products and services in a unique and different way to solve their problem. Instead of just selling a product, we are providing a real solution to their challenges.</p>
<p>Another thing that stands out is how we approach the total experience a customer has when dealing with SAFC. It is not about selling a product and then being done with the transaction. We want to contribute to process improvement for our customers, as well. Often times, something as simple as just being able to put on a container exactly how much product is in the container or being able to weigh to a specific weight allows customers to increase their throughput and provides them with more capability due to time and money saved.</p>
<p>SAFC is all about understanding the challenges and aligning capabilities and this is a key reason why we have been successful.</p>
<p><strong>SAFC Live: </strong>What do you see in the future for SAFC?</p>
<p>The future is as big and as bold and as successful as we choose to make it. SAFC has all the parts, pieces and capabilities to grow the business. Additionally, we have positioned the business very nicely for growth and we will support the growth by maintaining our current approach. SAFC looks at each customer as a market within a market and this allows us to work with them in a different way. This approach brings more humanity to our company, so even as we grow, we still have the end user in mind on a constant basis and our ability to personally understand the market will continue.</p>
<p><strong>SAFC Live: </strong>Outside of work, what are your passions?</p>
<p>I was raised in a farming area which has instilled the love of any kind of outdoor activity in me. I particularly enjoy golf and fly fishing and have a strong passion for wine. My wife and I enjoy traveling and it usually has a visit to a winery involved. In general, keeping a connection with the environment around us allows us to keep moving forward in our lives and we feel blessed to have that.</p>
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		<title>Nick Johnson Reflects on what Winning the EOA&#8217;s &#8220;Most Innovative Partnership&#8221; Award Means to SAFC</title>
		<link>http://safclive.com/nick-johnson-reflects-on-what-winning-the-eoa-partnership-award-means-to-safc/</link>
		<comments>http://safclive.com/nick-johnson-reflects-on-what-winning-the-eoa-partnership-award-means-to-safc/#comments</comments>
		<pubDate>Wed, 30 Nov 2011 17:00:23 +0000</pubDate>
		<dc:creator>SAFC</dc:creator>
				<category><![CDATA[CMOs]]></category>
		<category><![CDATA[Industry Overview]]></category>
		<category><![CDATA[Technologies]]></category>

		<guid isPermaLink="false">http://safclive.com/?p=730</guid>
		<description><![CDATA[Launched in 2005, the European Outsourcing Awards is a gala dinner event that celebrates outsourcing excellence in the pharmaceutical community. The annual event rewards successful companies for their innovation, dedication, application and excellence throughout bio and pharmaceutical outsourcing and wider business communities globally. At this year&#8217;s event, hosted during the global pharma exhibition, CPhI Worldwide, [...]]]></description>
			<content:encoded><![CDATA[<p>Launched in 2005, the European Outsourcing Awards is a gala dinner event that celebrates outsourcing excellence in the pharmaceutical community. The annual event rewards successful companies for their innovation, dedication, application and excellence throughout bio and pharmaceutical outsourcing and wider business communities globally.</p>
<p>At this year&#8217;s event, hosted during the global pharma exhibition, CPhI Worldwide, ICSE, P-MEC Europe and InnoPack, the EOA Gala Dinner took place at the Frankfurt Marriott Hotel. On October 25th, 2010 over 250 attendees represented more than 80 global companies to recognize their outstanding contribution to new and significant developments in contract services. CPhI exhibitor, SAFC, was there that evening and took home the award for the<strong><em> Most Innovative Partnership with Oncolytics Biotech, Inc</em></strong>. Here, <strong>Nick Johnson, Strategic Marketing Manager of SAFC</strong> discusses the partnership, the award, and what it all means to SAFC and Oncolytics.</p>
<p><strong><span id="more-730"></span>SAFC Live: </strong>Please tell us about the partnership.</p>
<p><strong>Nick Johnson:</strong> SAFC has worked with Oncolytics Biotech (a Calgary, Canada-based Biotechnology Company) on the production of their proprietary modified wild-type reovirus, Reolysin®, since 2005. It is a unique therapeutic virus currently in Phase III trials as a combination therapy for head and neck cancer treatment and a number of phase II trials for other cancer treatments.</p>
<p>Our relationship began with Oncolytics Biotech requesting our help to optimize medium formulation for Reolysin® production. Managing this process was important to help produce sufficient levels of the compound and to overcome production inconsistencies and limited production capacity, as well as to allow them to conduct critical clinical trials in a more timely fashion.</p>
<p>After the initial request was completed, Oncolytics decided to extend their involvement with SAFC to perform the contract manufacture of clinical batches and then on to process validation of the product. The partnership was advanced when SAFC was named as the commercial manufacturer for Oncolytics Biotech (read the press <a href="http://www.prnewswire.com/news-releases/oncolytics-biotech-inc-enters-into-commercial-supply-agreement-with-safc-121624748.html">release here</a>).</p>
<p><strong>SAFC Live: </strong>What is a reovirus and how does Reolysin® work?</p>
<p><strong>Nick Johnson: </strong>Reovirus, an acronym for Respiratory Enteric Orphan virus, is found naturally and thought to be present in human respiratory and bowel systems. It is not non-pathogenic, so there are no symptoms from infections; however researches have shown a link to reovirus and its ability to infect and kill cancer cells.</p>
<p>Oncolytics has taken the reovirus and applied it as the proprietary formulation Reolysin® as a therapeutic virus for the treatment of cancer. The virus has been demonstrated to replicate specifically in tumor cells bearing an activated RAS pathway and it is thought that this may be found in greater than two thirds of all human cancers. Reolysin® is designed to replicate in, and eventually kill, RAS-activated tumor cells. As cell death occurs, new virus particles are released and can then infect the surrounding cancer cells. The virus is believed to continue reproducing in this way until all tumor cells bearing the RAS pathway are destroyed.</p>
<p><strong>SAFC Live: </strong>Please tell us what is unique about this partnership between SAFC and Oncolytics Biotech and where you have seen success working together in this fashion.</p>
<p><strong>Nick Johnson:</strong> To answer this, first you have to look at the uniqueness of the Reolysin® product itself. Because Reolysin® is a therapeutic virus the process requirements are different from standard virus manufacture, which is most typically for vaccine production. The novelty of this type of therapy requires innovation in and around the actual processes and manufacturing of the product. It all started with developing the media needed for the manufacture of Reolysin®  and we have worked together from there.</p>
<p>Technical innovation has been critical to the development of the partnership. The Oncolytics Reolysin® virus is very pioneering, so as we entered the development phase with them, it meant entering a little bit of uncharted water. Not only that, but as you get closer to the market you see more regulatory questions being asked, and many that had never been asked before. We approached these problems from a unique perspective and focused on solving them as partners with the same goals.</p>
<p>The other significant area of success comes from recognizing that the last couple of years have presented a very challenging environment for biotech companies, with many companies having to slow down their development programs. Oncolytics and SAFC really worked hard together during this two year period to make sure the product moved forward despite market factors. It has been great experience for SAFC as Oncolytics takes the product from clinical phases in to making registration batches. We feel that the announcement of SAFC as their commercial manufacturing partner is a good testimony for the kind of relationship we have.</p>
<p><strong>SAFC Live: </strong>Were there challenges along the way?</p>
<p><strong>Nick Johnson:</strong> There are always the technical challenges to consider. Where you see the difference is how the partnership with Oncolytics has been managed through the difficult times and when challenges arose. We think we addressed these challenges in a flexible way that reflected a very close integration in the technical and commercial relationship between SAFC and Oncolytics Biotech.<strong><br />
</strong></p>
<p><strong>SAFC Live: </strong>What does the European Outsourcing Award 2011 (EOA award) mean for SAFC?</p>
<p><strong>Nick Johnson:</strong> The European Outsourcing Award 2011 (EOA) for Most Innovative Relationship with Oncolytics Biotech means a lot to SAFC. We are extremely pleased and excited to be recognized for this relationship. As an organization we feel that we need to become partners to our clients at all levels in developing therapeutics, building strong relationships and providing a high level of customer service. We feel that this award is recognition that we can excel both technically and as a partner. It is also special because here you see a successful partnership from the pharmaceutical manufacturing stand point, but then you realize that this is also a success in developing new therapeutics that can really change people’s lives.</p>
<p><strong>SAFC Live: </strong>What does the future look like?<strong> </strong></p>
<p><strong>Nick Johnson:</strong> Naturally, this is a very exciting time for Oncolytics with their product in Phase III; they are now pushing ahead for the commercial launch of Reolysin®. At SAFC we are excited for the future and we are very much looking forward to the product reaching the market and to having the partnership continue and grow.</p>
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