By Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader
Pam Garzone, executive director of biotechnology and clinical development at Pfizer worldwide research and development, is instrumental in implementing her company's outsourcing strategy. As the clinical team lead, she is accountable for the clinical development strategy for programs originating at Rinat, a research unit within Pfizer. Her duties include working with different functional expert groups such as biologists, clinicians, toxicologists, clinical pharmacologists, and statisticians. "I ensure that everyone on the asset team is in the same boat and rowing in the same direction," she says.
By Jose Castillo, Director of Cell Culture Technologies at ATMI LifeSciences
While incremental advances can create solutions to technological problems, sometimes the only way to achieve the required result is to rip up the old rulebook and start from scratch. That’s the approach ATMI LifeSciences took in developing a bioreactor for vaccine manufacture.
By Rafik H. Bishara, Steve Jacobs, and Dan Bell
More than a decade ago, the way business was conducted between pharmaceutical manufacturing companies and their supply chain providers was typically expressed through verbal expectations at the due diligence meeting, at the audit, or at the first project meeting, and that was pretty much done by using written bullet points.
By Scott Anderson, Kathy Lawrence, Dennis McCreary, and Melissa Wilcox
By using the RevealX™ detection technology of the Reveleris® system, which independently triggers fraction collection from multiple detectors including UV and ELSD, this work will demonstrate that these bottlenecks can be reduced or eliminated without reducing the recovery of compounds of interest.
By Betty Howard, Radiation TechTeam Manager, STERIS Isomedix Services
Many sterilization methods are available for pharmaceuticals, healthcare devices, and labware, including steam, sterile-filtration, ethylene oxide, vapor-phase hydrogen peroxide, electron-beam irradiation, and gamma irradiation. Each technique needs to be evaluated before use based on various criteria. Most importantly, one must consider how the technique will affect the final product characteristics and performance.
IBC's Biopharmaceutical Development & Production (BDP) Week event (March 24 to 27, 2014, San Diego, CA) provides the most in-depth coverage of bioprocessing methods in the field to give you the tools you need to develop and manufacture the increasingly diverse and complex molecules emerging in the biopharmaceutical pipeline. New registrations can save 20 percent off the standard rate with priority code BDP14BRO. Download the event brochure.