November 10 and 11, 2014
Hyatt Regency, San Francisco, CA
• Who should attend? Pharmaceutical and biopharm executives who form and manage outsourcing partnerships.
• What's on the agenda? Industry leaders providing educational sessions focused on best practices and lessons learned to help you avoid costly mistakes others have made in their outsourcing experiences.
Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.
How Genzyme Got Its Manufacturing Mojo Back By Nick Taylor, Contributing Editor
In the summer of 2009, Sandra Poole, newly appointed head of Genzyme’s Allston Landing biologics plant, and the site’s leadership team were confronting arguably the toughest job in biotech at the time. Days before her arrival, Genzyme shut down the site after discovering a viral contaminant. There would be no settling-in period. The entire company and thousands of patients were relying on this team to fix the problem.
White Paper: Facing The Challenges — Single-Use Approaches To Powder Transfer By Chris Rombach, ILC Dover
Media and buffer preparation is a key part of the biopharmaceutical manufacturing process, and while it doesn’t have to be carried out in sterile conditions, improving the powder transfer process makes this step cleaner, safer, and more efficient, protects personnel, and could cut time and costs as well.
White Paper: Connection Technology Advances Closed-System Processing By John Boehm, Business Unit Manager, Colder Products Company
The global demand for new biologics and vaccines, combined with the growing emergence of biosimilars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective.
Article: A Design Of Experiment (DOE) Approach For Purification Of Recombinant Proteins By Xuemei M. He, Sherif Hanala, and Mark Snyder, Bio-Rad Laboratories, Inc.
Mixed-mode chromatography has become an important purification tool for downstream process developers. Under specific purification conditions, one or more such interaction modes may be involved in the binding or repulsion between the target protein and the chromatography media. Therefore, the behavior of a protein during purification by mixed-mode chromatography is often not predictable on the basis of its pI or amino acid sequence.
Standard Flexsafe 2D validation bags made of the new polyethylene S80 film are designed for small-scale investigations and for the validation of the Flexsafe bag family. They are available in 150 mL and 500 mL volumes to support end users' process development and validation testing.
The demand for transporting medical and pharmaceutical products is exploding. So too are the challenges associated with moving time- and temperature-sensitive cargo in a manner that keeps the cold chain intact, and ensures documented quality of delivery.
In this webinar you will learn about the Emphaze AEX Hybrid Purifier — a multi-mechanism clarification device that embodies the philosophy of innovation necessary to transform and redefine the mAb purification process.