08.05.14 -- PhRMA, U.S. Biopharma Companies Partner For Arthritis Treatment R&D; Pfizer To Acquire Baxter's Commercial Vaccines
Life Science Leader and BayBio bring you interactive panels on the challenges to managing outsourcing relationships. Panelists include Andy Skibo (RVP, AstraZeneca; EVP, MedImmune), David Lowndes (SVP, Shire), Bob Kanuga (VP, Merck), Junning Lee (SVP, Theravance Biopharma), Terry Novak (COO, Pernix Therapeutics), and others. Learn more.
By Suzanne Elvidge, Contributing Editor
The trade in falsified medicines — medicines that look real but really aren’t what they seem — is a huge and growing one, and it is putting patients’ health and even their lives at risk. Along with regulatory authorities around the world, the European Union is putting directives into place that could begin to slow this deadly trade.
Dr. Rüdiger Lomb, World Courier
Given the high cost of conducting global clinical trials and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain — transportation and logistics providers included — conform to GxP guidelines.
By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg
Freeze drying is generally known to be a time-consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimizing a freeze-drying cycle in the laboratory — in particular the primary drying phase. Applying PAT (process analytical technology) in the laboratory can provide valuable information about product and process behavior and may help to identify the critical process parameters during cycle development and optimization.
A Q&A with James Espiritu, Laboratory Equipment Business Applications Manager, Miele
As in any analytical lab, cross-contamination due to improper glassware washing is one of the major sources of experimental error in a drug development lab. The good news is that cross-contamination is totally preventable and it is possible to have excellent control over the glassware washing operation using a properly validated, sophisticated lab washer.
ChemOutsourcing is the largest U.S.-based API show, attracting annually 700 to 800 chemists from the pharmaceutical, biotech, and chemical industries. The show focuses on API development spanning early drug discovery through chemical development and commercial supply. Attendees are executive scientists from pharmaceutical companies responsible for sourcing starting materials, intermediates, and active ingredients, and experienced in working with contract research and contract manufacturing organizations. Learn more.