SAFC Live – Blog on Biotech, Biopharma and Life Sciences

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

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

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