Welcome to another posting of ‘Industry Insight with Chester,’ a periodic round-up of news and views from around the Pharma and biopharma industries compiled by Chester Solack, Business Analyst at SAFC in Lenexa, Kansas.
Archive for the ‘APIs’ Category
Industry Insight with Chester: A Collection of Current Industry Updates
Friday, May 18th, 2012An API Regulations Update from the ICH Q3D Metal Impurities Workshop
Friday, April 20th, 2012As SAFC Live previously reported, the ICH Q3D Metal Impurities Workshop was held from April 4-5, 2012 at the Marriott Bethesda North Hotel in Bethesda, Maryland. The program focused on the new limits for element impurities in drug products and how they may impact businesses in the pharma industry. On day one, SAFC Quality Assurance Director, Patty Benson, participated in a panel titled “Perspectives From Active Pharmaceutical Ingredient (API) Suppliers”, along with a lineup of speakers from industry colleagues, the IPEC-Americas, CHPA and SOCMA’s Bulk Pharmaceutical Task Force (BPTF). The panel talked about draft guidelines and data implications, and their impact on pharmaceuticals. Patty’s input from an API maker’s perspective was complemented with an excipient user perspective from Janeen Skutnik-Wilkinson, Director of Quality and Regulatory Policy at Pfizer Inc. and an excipient maker perspective from David Schoneker, Director of Global Regulatory Affairs at Colorcon.
Patty’s presentation in the “Perspectives From Active Pharmaceutical Ingredient (API) Suppliers” panel is available for reference here: Q3D BPTF 0412.
To learn more about SAFC, please click here.
SAFC Presents at the Upcoming ICH Q3D Metal Impurities Workshop in Bethesda, Maryland
Monday, April 2nd, 2012From April 4-5, 2012, delegates will gather at the Marriott Bethesda North Hotel in Bethesda, Maryland for the two day ICH Q3D Metal Impurities Workshop that will feature a program focused on the new limits for element impurities in drug products and how they may impact businesses in the pharma industry.
On Wednesday, April 4th at 9am, SAFC Quality Assurance Director, Patty Benson, will participate in a panel titled “Perspectives From Active Pharmaceutical Ingredient (API) Suppliers”, along with a lineup of speakers from industry colleagues, the IPEC-Americas, CHPA and SOCMA’s Bulk Pharmaceutical Task Force (BPTF) to discuss the draft guidelines and implications data will have, as well as the impact on pharmaceuticals. Patty’s input from an API maker’s perspective will be complemented with an excipient user perspective from Janeen Skutnik-Wilkinson, Director of Quality and Regulatory Policy at Pfizer Inc. and an excipient maker perspective from David Schoneker, Director of Global Regulatory Affairs at Colorcon.
We hope to see you there to learn, network and exchange information amongst industry peers. To learn more about registration for the event, please click here. To learn more about SAFC, please click here.
SAFC Featured in Year-End Industry Reviews and a Comprehensive View of the Chemical Industry
Friday, December 30th, 20112011 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’s Glasgow Conference as #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.
Speciality Chemicals featured SAFC President, Gilles Cottier in a round-up piece, titled Fine Outlook in Frankfurt, that highlighted the recent CPhI Worldwide events in Frankfurt, Germany.
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 click here to read.
SAFC Live would like to thank you for time and readership throughout 2011 and we look forward to seeing you here often in 2012!
Optimizing High-Potency Manufacturing – An industry snapshot by PharmaTech’s Patricia van Arnum
Tuesday, June 7th, 2011Great article by Patricia van Arnum in the latest issue of Pharmaceutical Technology that talks about the importance of effective containment measures in API manufacturing and how a variety of process, equipment, and operational considerations need to be taken into account. From facility design to handling and storage procedures to the processes used in manufacturing to the choice of equipment deployed, specialist knowledge and approaches are necessary to ensure that containment and minimal exposure of employees is achieved.
Pro-Pharmaceuticals, Inc. Announces Agreement with SAFC
Monday, May 9th, 2011Last week, Pro-Pharmaceuticals, Inc., the leader in Galectin Therapeutics, and SAFC®, the custom manufacturing business unit of Sigma-AldrichTM, announced a multi-year agreement to ramp-up the manufacture of the active pharmaceutical ingredient (API) for its lead product candidate, GM-CT-01 (DAVANAT®).
CPhI News… SAFC Completes Expansion of High-Potency Fermentation Capabilities at Israel Site
Wednesday, October 6th, 2010SAFC today announced the completion of a state-of-the-art expansion of its Jerusalem, Israel facility. The additional capacity expands SAFC’s contract manufacturing capabilities in large molecule recombinant proteins and small molecule Active Pharmaceutical Ingredients (APIs) through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.
The 50,000 sq. ft. cGMP fermentation expansion, which is expected to begin production later in October 2010, will focus on niche fermentation of APIs and bulk drugs, producing secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. A 30,000 sq. ft. area of the new facility has been designed to be Biosafety Level 2 compliant – enabling manipulation of human pathogens. Capabilities include 1,000 and 4,000-liter tank capacities for bacterial and fungal fermentation, as well as explosion-proof suites.
“Fermentation is a long-standing technology, yet new applications have been recently discovered, including the synthesis of high potency compounds, which is a major growth area currently driving contract manufacturers such as SAFC to look beyond traditional active pharmaceutical ingredient (APIs),” said SAFC President, Gilles Cottier. “The Jerusalem expansion builds upon over 30 years of Sigma-Aldrich experience in the development and manufacture of hundreds of microbial-derived products, and is expected to help SAFC augment its industry-leading strategy of strength and expertise in emerging, highly-specialized technologies and difficult to manufacture products.”
At the Jerusalem facility, SAFC employs E.coli, Streptomyces sp., filamentous fungi and yeast, including risk group 2 human pathogens, across a wide product portfolio that includes small organic molecules and peptides, as well as larger molecules such as proteins, lipids and carbohydrates or macromolecules.
“We believe a primary differentiator at our Jerusalem site is our capability to safely manufacture niche small molecule products and biologics such as natural or recombinant proteins,” added Cottier. “In addition to having industry-leading techniques, capability and infrastructure to manufacture fermentation derived HPAPIs, the site is a multi-disciplinary, full-service facility offering purification and analytical expertise associated with fermentation technology such as microbiology, organic chemistry, biochemistry and molecular biology.”
