Archive for the ‘Vaccines’ Category

BREAKING NEWS: Strategic Agreement Announced Between Pfēnex and SAFC

Tuesday, June 7th, 2011

Today, Pfēnex, Inc. announced a non-exclusive partnership with SAFC, under which Pfēnex will support the engineering of strains and processes for SAFC’s biopharmaceutical fermentation business, strengthening capabilities in the areas of microbial strain engineering and the production of complex protein therapeutics and bioconjugation. By pairing Pfēnex’s cutting edge expression technology with the broad range of ingredients and world-class CMO services and facilities of SAFC, the partnership aims to facilitate more comprehensive and time sensitive vaccine development and production for clinical phase trials; both companies are excited about the expansion of capabilities through working together.

A follow up interview with Bill Taylor, Director, Business Development & Commercial Operations of Pfēnex will be available later this week. And next week, an interview with Mark Cassidy, VP of SAFC will go live. These interviews will cover more in-depth detail of this partnership and the benefits it will provide from the perspective of both companies.

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“A World of Innovation” – Dr. Sarah Houlton reports for BioProcess International on the SAFC/Sartorius downstream processing day

Tuesday, June 7th, 2011

“The world faces a clear need for innovative biological products to treat and prevent diseases that cause significant health burdens. What might be less obvious is a need for innovation in biomanufacturing processes. If these products are to be made more efficiently and cost-effectively through less wasteful and safer means, then improvements are definitely needed” writes Dr. Sarah Houlton in the excellent report published today in BioProcess International that reviews the Downstream Processing Day co-hosted by SAFC and Sartorius Stedim Biotech and held in Liverpool, UK earlier this year.

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Challenges And Changes in Vaccine Manufacture – PharmTech Europe’s Stephanie Sutton reports from the recent SAFC/SSB Downstream Processing Day

Tuesday, February 1st, 2011

Last week saw the Downstream Processing Day, hosted by SAFC and Sartorius Stedim Biotech, take place in Liverpool, UK.  One of the editors attending the event was Stephanie Sutton from Pharma Technology Europe, who wrote that “a lot of interesting topics were discussed, including vaccine manufacture, which is a particularly hot issue both inside and outside of the industry at the moment.   In a very interesting review of the event, Stephanie goes on to talk about a presentation given by Hikmat Bushnaq-Josting, Technical Manager at SAFC, which discussed some of the

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Viral Vaccines Case Study

Thursday, February 18th, 2010

The growing interest in gene therapy drugs and a resurgence in interest in vaccines have led to an increasing demand for large scale virus manufacture. Specialist contract manufacturers are able to make viruses quickly, safely and flexibly to meet this demand, partly thanks to the new breed of disposable bioreactors.

Link To Article

Trends in the Manufacturing of Viral Gene Therapeutics and Next Generation Vaccines

Thursday, January 28th, 2010

In this article published by In-Pharma Technology, Jeff Strobel, Site Director of SAFC’s Carlsbad, CA. facility, discusses some of the trends and developments surrounding the manufacture of viral gene therapeutics and future iterations of vaccines. Gene therapy has historically been a ‘catch-all’ phrase for those products using a viral vector, plasmid, or cell as a delivery vehicle for a gene product. Early applications in this field really developed in the 1980s and 1990s, often using viral vectors such as adenovirus or retrovirus to deliver genes. There are still no approved gene therapy products in the western world, but numerous applications are being pursued, notably in cancer, central nervous system disorders and cardiac disease. There are also some exciting studies for diseases of the eye. In sum, researchers are now being more realistic than in the early days, seeing the future of gene therapy in providing effective treatments, not cures.

The article looks at how safety used to be a significant issue but the dangers are now much better understood and provided for. In fact, many of the companies with gene therapy products have a higher standard of efficacy and safety. Also covered are changing trends, such as the use of disposable equipment, the growing interest in which has been supported by the entrance of more suppliers into the market. The importance of containment and safety regarding the virus’ and treatment of the facilities is also discussed in depth.

Read the full article here

Find out more about this topic and SAFC’s Carlsbad facility by clicking here…. Read More

SAFC Proceeds With Technology-Based Growth

Saturday, January 9th, 2010

“The custom manufacturer and fine-chemicals company adds further capabilities in high-potency and viral-product manufacturing and targets synergies in gene editing with its parent company, Sigma-Aldrich.”

Great article by Patricia van Arnum for Pharmaceutical Technology that looks at how Sigma-Aldrich and SAFC are “leveraging their slate of technology-based capabilities as part of their growth strategy.” The article covers antibody drug conjugation and high-potency manufacturing, viral-product manufacturing and how Zinc Finger Nuclease technology is being used to develop cell lines in the company’s viral-product manufacturing business and the development of media.

Read full Article

Webinar – Defining Hydrolysates: An Approach for Generating a Chemically Defined Alternative

Thursday, November 5th, 2009

In the biopharmaceutical industry it is common to see protein hydrolysates in cell culture processes as part of a complete medium formulation or a fed-batch bioreactor process.  It is well documented that hydrolysates can have a substantial positive impact on cell growth and/or protein production. However, given the undefined nature and the lot-to-lot variability associated with hydrolysates there exists a need to mitigate these risks with a chemically defined (CD) alternative that can maintain the desired performance.  SAFC Biosciences® is now offering a new product that meets this goal and can quickly convert an undefined process to fully defined.  The approach to solving this complex puzzle is discussed within, including details on how “active” hydrolysate fractions were found and the subsequent identification of the compounds contained within.  The knowledge gained from this work was used to design EX-CELL® CD Hydrolysate Fusion, which is capable of replacing the functions of hydrolysates in many Chinese Hamster Ovary (CHO) cell systems.

What was covered in the webinar:

  • Understanding of hydrolysate complexity and source of variability
  • Analytical technologies used to characterized undefined components
  • Impact of hydrolysate addition on CHO cell gene regulation and overall performance
  • Product scale-up considerations
  • Chemically defined application proofs

This webinar took place on November 18,2009

To download and view the webinar click on this link:

https://www1.gotomeeting.com/register/147249640

Mention priority code BWS9234SW2