While at TIDES, SAFC showcased strong experience in the area with the Proligo range of raw materials (manufactured in the Hamburg facility). CUTAG CPG was especially highlighted during the event as a universal support that helps customers increase the speed of their oligonucleotide synthesis and produce high-quality oligonucleotides with controlled cost and reduced inventory demands.

In contrast to other supports that attach up to four nucleosides, only one nucleoside is needed when using CUTAG CPG. With the same support being used regardless of which nucleic acid is first, it also reduces the potential for error in column selection. This is particularly true for a parallel synthesiser where 96, 192, or more, wells are being used at the same time, and may contain all four.

Unlike other universal supports, CUTAG CPG does not form aniline as a by-product. Rather than aniline-producing phenyl bicycle linkers, it uses an N-methyl bicycle linker. The methylamine this produces is much easier to remove, and does not add extra purification steps to the process, cutting time and cost further.

As more oligonucleotide drugs reach the market in coming years, the current climate of ever-increasing pressures on costs means that technologies like CUTAG CPG will prove to be key for the advancement of the sector. The technology allows biotech companies to save time and money in the synthesis of oligonucleotides and focus on innovation.

To learn more about SAFC’s Proligo line, please click here.

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CEO Rakesh Sachdev leading the Sigma-Aldrich team to ring NASDAQ opening bell

NASDAQ honored SAFC’s parent company Sigma-Aldrich as the second highest performing company on their list of top 100 growing companies today, May 21^st. Representatives of NASDAQ and Sigma-Aldrich joined Rakesh Sachdev (CEO) and Jan Bertsch (CFO) to celebrate this honor as they rang the opening bell of the NASDAQ stock market at 9:30am ET in Times Square.

Sigma-Aldrich was recognized as a leader in Life Science and High Technology, with a nod to the company’s focus on innovation through a large offering of products that are used in research, biotechnology, pharmaceutical development, and manufacturing. Since 2000, Sigma-Aldrich has grown 600% and as Rakesh mentioned during his speech this morning, expects to continue with exceptional growth.

To view USA Today’s story about Sigma-Aldrich being the second highest performing company on the NASDAQ, please click here.

The post Sigma-Aldrich Rings NASDAQ Opening Bell at Times Square appeared first on SAFC Live – Blog on Biotech, Biopharma and Life Sciences.

Lisa Silver, Manager of SAFC Sourcing Services and Supply Chain

SAFC Lives presents personnel profiles where we talk to the people who make SAFC tick to find out more about their personalities, position, what drives them, and what they enjoy doing when they are not playing a critical role in the ongoing growth of SAFC.

In this edition, we talk with Lisa Silver, Manager of SAFC Sourcing Services and Supply Chain in St. Louis, Missouri.

SAFC Live: Hi Lisa, let’s start off with a background of your position and an idea of your day-to-day duties.

I manage the SAFC Sourcing and US Quote Support teams; both of which have significant value to our customers. The US Quote Support team directly supports the sales organization for out of stock products requested by customers. This organization has a wealth of knowledge about internal operations and is vital to the success of SAFC’s sales team.

The SAFC Sourcing Service / CHESS™ (CHEmical Strategic Sourcing) Program is a third-party sourcing and procurement service performed for Top 100 SAFC Commercial customers under contract. Our two major customers are Merck and Amgen.

My role is to help maintain our current customer base in the Sourcing / CHESS™ program and assist with the development of new clients. Additionally, I provide assistance to internal sourcing requirements and lead the Supply Chain Transparency Project. I also work with the SAFC management team to support supply chain initiatives such as forecasting for SAFC, I/S and e-business strategies for the teams, and performance measurements for our service.

SAFC Live: Tell us about your time at SAFC. What brought you here, how long have you been here and how has your role developed?

I came to Sigma-Aldrich a year after finishing my undergraduate degree in Chemistry from the University of Missouri, St. Louis and have been here for nearly 17 years. The job market was very challenging after graduation; I first took a job with a small company in the St. Louis area responsible for radiochemical production. When offered an opportunity to join Sigma-Aldrich, I jumped at the chance and joined as an analytical chemist in the assay lab at Dekalb.

After about two years in the chemist role, I moved to procurement for three years. Then in 2001, I moved over to the SAFC side of the business and have progressed from there. What started as a sourcing role moved into project management and then came full circle to where I am now. It has been an organic evolution, and it is a role that I truly enjoy.

SAFC Live: What has inspired you during your career at SAFC? What gets you out of bed in the morning?

Above anything, I really love helping customers. Back in the dark ages when I was working to put myself through college, I worked at a St. Louis grocery store chain. I loved interfacing with our customers. Flash forward to today, and it is still the same thing that drives me – without needing to collect carts.

This job gives me the ability to connect with SAFC’s user community and create. When a customer needs something, I get to go out and proactively work with my team to find a solution. If we do not already have a solution, then we work to build one.

It is an honor to say that I truly love what I do. My work directly relates to SAFC’s internal excellence policy and provides me with the opportunity to deliver something new and innovative every day.

SAFC Live: How do you think SAFC solves problems for customers?

SAFC focuses greatly on our customers. If we don’t have a solution readily available, we will work to make one. We look to take a holistic approach and are constantly working to provide customers with innovative service. At the end of the day, we make their problems our problems and we do not stop until they are solved.

SAFC Live: What do you see in the future for SAFC?

SAFC is an exciting place to be; I think we are at a crossroads with the organization and customers. This is being driven by the many changing requirements around quality in the industry. In the past, buyers would be more concerned with cost savings and less about quality. Now we are working in an industry where quality is king.

The key to SAFC’s success is finding that balance between quality and cost. At SAFC we are always looking at ways to leverage sourcing so that we can differentiate ourselves to our customers. Fortunately, we are able to complement that with the ability to deliver unique materials, provide supply chain transparency, and support it all with depth of service.

SAFC Live: Outside of work, what are your passions?

Outside of work, I am devoted to my family. My husband and I have two teenage children who are awesome. My daughter is 15 and my son is 12; they bring us great joy.

My other passion lies with being creative and hands-on. I love to do anything from paper crafting and making music, into home improvement and renovation projects. I really enjoy the process of making something from start to finish and being able to exercise my creativity.

The post SAFC Lives: Lisa Silver, Manager of SAFC Sourcing Services and Supply Chain appeared first on SAFC Live – Blog on Biotech, Biopharma and Life Sciences.

It will kick off on Thursday, May 16th at the Bolger Center in Potomac, MD. Then on Tuesday, May 21st guests are invited to theHyatt House in King of Prussia, PA. Finally, a Thursday, May 23rd session at the Le Meridien in Cambridge, MA is available.

These informative sessions offer attendees with a chance to learn and network. Each seminar features input on key topics industry topics, including:

•    Regulatory Updates

•    Virus Risk Mitigation for Raw Materials

•    Massively Parallel Sequencing for biosafety testing

•    Biomanufacturing Case Studies

•    Biosimilars (worldwide regulatory expectations and bioassays for potency)

•    Viral Clearance (impact of filter variability)

•    Molecular Methods for biosafety testing

Refreshments, lunch and a drinks reception at the end are included in the session. A full agenda with speaker profiles and the annual seminar schedule can be found by clicking here.

Click here to register for this event.

The post BioReliance Seminar Series Makes its Way Back to the US for May appeared first on SAFC Live – Blog on Biotech, Biopharma and Life Sciences.

Irvine Groundbreaking April 2013

Ground was broken on April 24^th for the new Dry Powder Media (DPM) manufacturing facility that SAFC is building on its Irvine, Scotland site. The addition of dry powder milling and blending capability to this facility will complete a 5-year Capital Expansion Plan SAFC initiated as part of its long-term commitment to supporting customers in the growing industrial biopharmaceutical market. The purpose-built facility will produce animal component free (ACF) media and will offer regional support to the European market along with manufacturing redundancy to its North American sister facility in Lenexa, Kansas.

The new facility at Irvine is currently under construction with commissioning and qualification scheduled to start Q4 2013. The fully qualified facility will be handed over for routine manufacture during Q1 2014.

Here, the team celebrates the ground breaking, which was well attended by Scottish officials and local media.

The press release announcing the expansion can be found by clicking here. For more information about the project, please click here.

For a recent interview with site director, Fiona Oldfield, please click here.

The Scottish Enterprise also highlighted SAFC (and parent company, Sigma Aldrich) as a key global player in fine chemicals and the future of Scotland in this September 2012 release.

The groundbreaking was recently featured in Powder Bulk Solids. See the story by clicking here.

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Next up on the schedule, BioReliance will be onsite in San Francisco, CA at the World PGx Summit where industry executives will gather to “harness genomic information, predict patient response and develop better, safer drugs”. Hosted at the Hotel Monaco from April 30th to May 2nd, the agenda is focused on pharmacogenomic technologies and how they influence the industry from a manufacturing and end-user standpoint. Starting off with pre-conference workshops on April 30th, the program will look into lab standards, regulatory considerations, increasing safety, sample collection and more. 

On Wednesday, May 1st at 9:50am, BioReliance’s own John L. Kolman, Ph.D., Executive Director, Head of Genomics, will make a presentation titled: Validation of a Multiplex ADME SNP Assay for Clinical Trial Studies. The Illumina® VeraCode® ADME Core Panel – an alternative to DMET.

In this presentation, Dr. Kolman will address how assays for novel genetic biomarkers must be analytically validated to specific international regulations for use in late stage Clinical Trials. He will go on to provide a look into how skilled delivery of these services becomes more important as the industry embraces new FDA guidance on patient genotyping from CDER, CBER and CDRH (Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling). His presentation will then round out with a demonstration of the execution of an assay validation consistent with this guidance.

The full agenda for the PGx Summit can be found by clicking here.

Registration for the event is still open, and BioReliance invites you to join us.

Even if you cannot attend the event, we would still love to hear from you. Click here to learn more about Dr. Kolman’s presentation and what BioReliance has to offer.

The post BioReliance Heads to San Francisco for the World PGx Summit Next Week appeared first on SAFC Live – Blog on Biotech, Biopharma and Life Sciences.

SAFC Welcomes you to booth I-16

SAFC is once again onsite at CPhI Japan as both an exhibitor (Booth I-16) and presenter. The event is currently underway at the Big Sight Exhibition Centre in Tokyo from Wednesday, April 24^th – Friday, April 26^th and as we mark our 11th year of participation, it is fair to say that we have enjoyed watching the event evolve through the years. In fact, SAFC was honored last year by event organizer, UBM Live, as part of a group of 47 exhibitors that have attended CPhI Japan since 2002!

Japan has established itself as the leader of Asia’s pharmaceutical industry. It is also the world’s second largest market known for innovative technologies and products discoveries. CPhI Japan is unique in its ability to bring together key global players in the industry, including major suppliers and influencers, in a unique platform that offers direct access to this flourishing market.

Our team is ready at Booth I-16!

SAFC is especially active this year, with three presentations hosted throughout the event. Featured topics include SAFC’s innovative process development in the Bio-Pharmaceutical market; capability in featuring the highest level of quality and containment engineering to handle cytotoxic and category IV potent compounds manufacturing site; and SAFC’s commitment in supporting clients from the initial development of a viral construct through cGMP manufacture.

The complete SAFC presentation schedule follows:

Wednesday, April 24, 14:30 – 15:00 in Room C

PharmaGrade and SAFC Japan Service for Scale-up – Presented by Makoto Sasaki, SAFC

Thursday, April 25, 14:30 – 15:00 in Room B

SAFC’s Solution with cGMP high potent API manufacturing capability – Presented by Masa Fujino, SAFC

Friday, April 26, 11:00 – 11:30 in Room C

SAFC’s contract manufacturing of viral therapeutics and vaccines for commercialization – Presented by Hillary Penir, SAFC

We hope to see you onsite at Booth I-16, and invite you to join our presentations.

See you in Tokyo!

The post SAFC is Onsite for 11th Visit to CPhI Japan in Tokyo appeared first on SAFC Live – Blog on Biotech, Biopharma and Life Sciences.

Jean Chabbert, EMEA Sales Support Manager

SAFC Lives presents personnel profiles where we talk to the people and personalities who make SAFC tick to find out more about their position, what drives them, and what they enjoy doing when they are not playing a critical role in the ongoing growth of SAFC.

In this edition, we talk with Jean Chabbert, EMEA Sales Support Manager located in the Gillingham, UK facility.

SAFC Live: Hello. Please start us off with a background of your position and an idea of your day-to-day duties.

I am the EMEA (Europe, Middle East, Africa) Sales Support Manager, working directly with the sales support group. The group includes an EU quote department in Poole, UK; a customer service team in our Irvine, Scotland facility; an order entry management team; and a Sourcing Team in Gillingham, UK. Our group is part of a greater global supply chain team, so I report our progress directly to the VP of SAFC Supply Chain, Marketing and R&D, Deborah Slagle.

This position has many facets. In addition to aligning the strategy of the team, I also support SAFC Commercial and Applied Market customers in the EMEA region. I come in and look for alternatives for customers and participate in providing general quotes. I also manage orders and oversee the entry process. By being fully involved in the team strategy, our customer-facing experience, and the back-end processes, I am able to keep an eye out for new ways to improve the supply chain along the way.

On a day-to-day basis, I am often meeting with a customer or working on initiatives related to supply chain solutions or supply chain issues. As a team, we are always identifying new short-term or long-term process initiatives. All of the work comes down to improving the service level for our customers, so that means I take on a broad range of activities.

SAFC Live: Tell us about your time with SAFC. What brought you here, how long have you been here and how has your role developed?

I started off as a chemist at the bench. Though I had graduated with a Master of Science in biomolecules, I focused a lot more on chemistry than biology in school.

After school, I went to a company called Genset in Paris, which was acquired by Proligo in 2003. I then moved into my role with Sigma-Aldrich as part of Proligo being acquired in 2005. At that time of the acquisition, I was in charge of oligo production at our Boulder, CO manufacturing site. Because of my experience, I was given the opportunity to move to The Woodlands, TX to join the Sigma-Aldrich peptide and oligo manufacturing group; I took the offer and stayed in the role of production manager for the team for about 2 years.

In 2007, I transitioned into operations management for oligo and peptides at the Woodlands site. Then in the end of 2008 I took an opportunity to move back to France as a site manager in the Evry oligo-manufacturing site, where I stayed for three years.

My current role in Gillingham with SAFC is actually quite new; I started here in the beginning of 2012.

SAFC Live: What has inspired you during your career with SAFC? What gets you out of bed in the morning?

There are quite a few things that inspire me about my time with Sigma-Aldrich and now SAFC.

For starters, I always wanted to work for a global company with opportunities to grow and continually push myself outside of my comfort zone. I have that, and I feel lucky to look back and know that in the past 7 years, I have had 4 jobs in 3 countries. That time has allowed me to meet so many great people and work with technical experts and business leaders across the globe. The exposure to intelligent people and the daily challenges keep me motivated.

SAFC Live: How do you think SAFC solves problems for customers?

While I have only been with SAFC a short time, it has been invaluable. I am able to participate with key customers and learn new things all the time. To be honest, I have always been very impressed by how strong the business relationships are between SAFC and customers. It all comes as a result of providing solutions and solving problems. We know that delivering, regardless of the problems the customers have, is the key to creating an experience that sets us apart. It is our driving goal to provide exceptional solutions that are on quality and on time.

SAFC Live: What do you see in the future for SAFC?

Right now we are in a challenging market – there has been a lot of uncertainty and disappointment. Yet I see a bright future for SAFC because I think we are doing the right things. We have really taken our focus away from revenue and placed it on the customer experience. We figure the bottom line is that happy customers bring success that is consistent and expansive.

The recent acquisitions, in conjunction with the realignment of business units, reflect an exceptional investment in the future. SAFC is continuing to put time and money into offering world-class facilities and making sure the right people are doing the right jobs. The reorganization has allowed us to improve our customer-centric approach and bring attention to any updates needed to ensure quality and transparency is built into our supply chain.

SAFC Live: Outside of work, what are your passions?

I greatly enjoy fishing, tribal art, and free diving. While there is no obvious link between the three passions, I can say that they are all very relaxing and provide me with lots of opportunities to experience and learn new things. They also help bring together my family, including my wife, 4-year-old son and 1-year-old daughter.

Though I have been fishing and diving since I was a kid, my interest in African/tribal art came later in life. I am so glad that my family can bond through these interests; we always have an excuse to have fun, relax and spend quality time together.

The post SAFC Lives: Jean Chabbert, EMEA Sales Support Manager appeared first on SAFC Live – Blog on Biotech, Biopharma and Life Sciences.

As a CMO, SAFC has firsthand experience with different types of partnerships and the benefits that outsourcing can offer to a pharmaceutical company. From R&D phases through to commercial manufacture, the outsourcing model consistenly offers exceptional results when working with the right partner. In a document titled ‘How can pharmaceutical and life sciences companies strategically engage global outsourcing?’ Pricewaterhouse Coopers (pwc) notes that some of the clearest benefits of the outsourcing model include: 

·         Faster time to market
·         Cost advantage
·         Risk management
·         Strategic focus

Even as the benefits of outsourcing to a CMO continue to be proven, there is still a bit of a stigma attached to outsourcing – often times, companies can perceive it as losing control of their process, or even risking the loss of valuable intellectual property. A recent Cutting Edge report,  ’Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy‘, noted that while the amount of outsourcing has dramatically increased (more than 68% of pharmaceutical companies are outsourcing services – a drastic increase from 2010), the amount of budgeted work outsourced tends to remains lower, hovering around 10 to 20%.   

SAFC has actively participated in industry discussions about the considerations and benefits of outsourcing. Andreas Weiler, Global Head of Strategic Marketing recently participated in a GEN feature about ‘Choosing the Right CMO‘. And in March, Dave Backer, Senior Director and General Manager of SAFC and Mike Garrett, Senior Director of Global Marketing for BioReliance weighed in on ‘Securing the Supply Chain‘ with BioPharm International.

We would be interested to know, what has your experience with outsourcing to a CMO, either as a provider or customer, been? In the meantime, you can learn more about the full SAFC portfolio, by visiting www.safcglobal.com

The post Outsourcing Offers a New Way to Move Ahead appeared first on SAFC Live – Blog on Biotech, Biopharma and Life Sciences.

As a company that likes to stay ahead of the trends, quality has long been a focus area for SAFC. From employing various global teams dedicated to quality and supply chain transparency, to re-categorizing product offerings to include fully validated products, SAFC has been busy working on answering this industry need.

Originally launched in 2012, SAFC’s PharmaGrade portfolio addresses the need for greater supply chain transparency and enhanced quality for biopharmaceutical manufacturing applications. Products in the PharmaGrade portfolio are provided with full documentation of manufacturing history, and are compliant with either GMP (Good Manufacturing Practice) standards or the SAFC Elite Quality grade standards. All PharmaGrade products are quality assurance reviewed and released, and include applicable change control notification, plus a dedicated product support team.

Here, SAFC’s own Beth Ann McLane, product manager for enhanced quality, talks supply chain security with Cynthia Challener of Pharmaceutical Sciences, Manufacturing, and Marketplace Report. The following feature titled Strategies for Achieving Biopharmaceutical Supply Chain, takes a look into how SAFC is ensuring supply-chain transparency and quality for raw materials with the PharmaGrade line.   

The PharmaGrade line recently expanded to include 20 new products, and SAFC expects the portfolio to double in size by the end of 2013.The full press release on the expansion can be found by clicking here.

To learn more about PharmaGrade, please visit: www.safcglobal.com/pharmagrade

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