SAFC is to host a series of three presentations at the forthcoming BioProcess International 2010 Event, to be held from September 20-24 at the Rhode Island Convention Center, Providence, RI. The BPI event, titled ‘Accelerating and Optimizing Biopharmaceutical Process and Product Development’, will feature the following presentations from SAFC:
SAFC and Novozymes Extend Exclusive Marketing and Distribution Deal For LONG®R³IGF-I (LONG®R3) Growth Factor
Posted by Mark August 19 2010
SAFC and Novozymes Biopharma today announced a 10-year extension of their joint agreement under which SAFC retains exclusive marketing and distribution rights for Novozymes Biopharma’s LONG®R³IGF-I (LONG®R3) growth factor used for industrial cell culture applications.
The highly potent growth factor is manufactured specifically for customers in the cell culture market, to enable them to reduce operational and regulatory complexity and minimize manufacturing risk.
Read the full details of the agreement extension here.
Video exclusive: in-Pharma Technologist Takes a Look Inside SAFC's Verona, Wisconsin HPAPI Facility
Posted by Mark August 3 2010
“Greater recognition of toxicity risks of HPAPIs and continued growth of oncology sector are driving drug industry demand for safe manufacturing capacity says” writes Gareth MacDonald of in-Pharma Technologist, talking about the rationale behind SAFC’s recent $30m expansion of its Verona, Wisconsin HPAPI facility.
Gareth was invited to enjoy an exclusive look behind the scenes at the Verona plant’s capabilities and spoke about the market with operations director David Bormett, who also gave an insight into the containment technologies used at the plant, as well as the trends and growth that SAFC is seeing is the field of highly potent compounds, which offer greater efficacy in smaller doses in numerous areas of medical treatment, particular in the development drugs that target cancers.
Forget MTV Cribs… The really fascinating stuff is happening here…
"Changing the Concept of Quality" – Quality and Regulatory Guru Tom Beil Talks With Man Chem’s Hilary Ayshford
Posted by Mark August 3 2010
“The cost of a pharmaceutical ingredient is determined by far more than its monetary value,” writes Hilary Ayshford, Editor of Manufacturing, in the introduction to her interview with Tom Beil, VP of Quality and Regulatory Affairs at Sigma-Aldrich.
Tom Beil, VP, Quality and Regulatory Affairs, Sigma-Aldrich
Never a truer word has been spoken, or written in this case and, despite a decrease in both the number of recorded cases of suspected IP infringement AND the number of good detained under such suspicion in 2009 (compared to 2008) by EU customs, the numbers are still a major cause for concern to the global pharma and bio-pharma industries.
In the article ‘Changing The Concept of Quality,’ published in the current issues of Manufacturing Chemist, Beil talks about the ongoing problem of counterfeit pharma and how the perception of quality is changing as “more people start to look at their supply chain, the more they realize that they don’t know where those products come from.” As a result, the total cost of quality is now something more than a buzzword…. Moreover, it’s looking at the overall supply chain as a matrix rather than a linear process.
The importance of quality and the auditing system required globally to ensure that the pharma industry is doing its utmost to prevent both supply chain failures and the threat of counterfeit, that SAFC, along with numerous other pharma players, became founding partners in Rx-360, “a consortium that is aimed at assuring the quality and authenticity of the products moving through the supply chain. Members also include Abbott, Amgen, BASF, Boehringer Ingelheim, AstraZeneca, GSK, Novartis and Pfizer, as well as many other notable names.”
You can read Hilary Ayshford’s fine article in full right here.
Modular Manufacturing – time to be embraced by biopharm CMOs?
Posted by Mark July 19 2010
In his recent article – “Thinking Inside the Box” – published over at Pharmaceutical Technology, Erik Greb takes an in-depth look at “a modular approach to biopharmaceutical production” which “could bring process flexibility” to the industry as it “allows plant and process designers to divide the manufacturing process into standardized, discrete units that can be assembled, moved, and disassembled easily.” As CMOs continue to feel pressure from customers to reduce costs, Greb talks to a number of industry luminaries, including SAFC’s Dave Backer, to find out if, and how, contract manufacturing organizations are starting to embrace the modular concept. Fascinating stuff and well worth a read….
Read the full article here.
"Contained but not constrained" – Trevor Calkins talks high potency facility design and considerations with Cleanroom Technology
Posted by Mark July 19 2010
Highly potent drugs require specialized manufacturing facilities to ensure they do not escape into the environment. In this exclusive article with Cleanroom Technology, SAFC’s Trevor Calkins describes in detail, from the initial stage of a project through potency classification to specific design and containment specification, how the company designed its multipurpose manufacturing plants to meet the complex containment requirements.
Read the full article here
Disposable processing driving investment in media business, says SAFC's Dave Feldker
Posted by Mark June 23 2010
During the SAFC global media summit held in Chicago recently, In-PharmaTechnologist’s Gareth MacDonald caught up with SAFC Pharma Vice President Dave Feldker to talk about the company’s investment at its St. Louis, MO. and Irvine, Scotland sites in developing its liquid cell culture reagents in response to growing biomanufacturing industry demand. Feldker also discusses how this investment dovetails with other investment that SAFC has made recently, in particular in the expansion of its dry powder media manufacturing capabilities at its Lenexa, KS. site.
Check out the full video interview here
Recalling pharma – Chemistry World looks at the critical need for quality monitoring and raw materials characterization in bio-pharma manufacturing
Posted by Mark June 23 2010
A very interesting article by Sarah Houlton appeared in Chemistry World this week that looks at how the withdrawal of drugs from the market and manufacturing failures have served to highlight the need for the pharma industry to ensure that the medicines supplied to consumers only contain what they should.
Featured in the article are Chris Oldenhof, who works in external regulatory affairs at Dutch chemicals producer DSM, Guy Villax, chief executive of Portuguese manufacturer Hovione, and Bruce Lehr, Director of Development at SAFC. Lehr talks about how Pharma companies are seeking greater information from suppliers, including greater levels of characterization around raw materials. Building on this theme, SAFC has set up its own enhanced raw material characterization program for cell culture media sold to biopharma manufacturers. Lehr goes on to talk about the steps that SAFC has taken to monitor and deal with any variance in composition of materials and the need for due diligence throughout the supply chain. and how putting that in place can ensure all materials meet all specifications.
You can read the article in full here:
As ever, we welcome your thoughts on the topics raised and encourage you to comment.
Sunshine, positive industry vibes, one cutting edge-HPAPI facility and Wisconsin highways all feature as SAFC's global media summit is a hit in Chicago…
Posted by Mark June 18 2010
The first ever SAFC Global Media Summit was held in Chicago last week and was attended by 11 journalists from leading chemical, pharmaceutical and bio trade publications from Europe and the United States. Having previously held separate events in Europe and North America, the Chicago summit was the first ‘global’ event to be organized by the Company.
Hosted by a senior executive team from SAFC comprising President Gilles Cottier, VP of Marketing Ed Roullard, VP of Sales and Operations Dave Feldker and VP of Quality and Regulatory Affairs, Tom Beil, the event was hosted in downtown Chicago. Proceedings kicked off on the evening of Tuesday 8th June with an informal drinks reception, which was welcomed by the journalists, many of whom had travelled from Europe to attend. The event kicked into high gear the following morning with a series of briefings held in the Dana hotel’s 26th floor Sky Lounge. Luckily the previous night’s torrential rain had abated, to be replaced by glorious sunshine, which enabled the party to take full advantage of the spectacular views afforded by the outdoor balcony area. Read the rest of this entry »
SAFC introduces environmentally-safe broad spectrum biocide for medical IVD apps
Posted by Mark June 17 2010
SAFC yesterday announced the roll-out of a new, ‘ready-to-use’ solution-based biocide, ProClin® B-119 (www.safcglobal.com/proclin). This safe and effective biocide has been specifically designed for challenging formulation conditions and works across pH levels 4-12 and at temperatures of up to 90 degrees centigrade to control microorganisms, providing stability and reliability of in-vitro Diagnostics (IVD) reagents used in medical testing. ProClin B-119 is formaldehyde-free and has been specifically designed to meet a wider range of pH levels and temperatures than biocides currently on the market. Read the rest of this entry »
