Outsourcing Articles

Across the pharmaceutical industry, dramatic and durable changes to the operating environment are calling for modifications to companies’ strategies and structures. The industry is facing a period of eroding pricing power, falling growth in the consumption of branded drugs, and tighter regulatory standards.

This time, it was different. While the extent of consolidation in outsourcing in 2008 was not bad, we suspect it would have been stronger had it not been for deteriorating economic and capital market conditions. Moreover, the uneven financial results of some drug development firms and outsourcing service providers probably inhibited many contemplated transactions from coming to fruition.

met Mike Kowolenko at the BIO conference in San Diego in 2008. We had an entertaining conversation about his new role at Wyeth (see his biographical note on page 80 for more information on his title and responsibilities), discussing the quirks and intricacies of biomanufacturing at a major pharma company.

As the Environmental Health & Safety (EH&S) manager of a small but growing drug discovery company, I developed a potent compound control program in 2004-2005.

Testing of excipients as described by pharmacopoeia monographs has advanced over recent years to include highly sophisticated techniques such as X-ray Diffraction (XRD) and Near Infrared (NIR). However, these monographs have mainly focused on standards for chemical product characteristics.

Stability studies are a critical part of the drug development process and are essential for regulatory approval. Stability studies are required at all phases of the drug development life cycle. They establish the groundwork for understanding if the drug candidate is viable. Will the dose range and the formulation prove to be sufficiently robust to support the candidate’s safety and efficacy?

Rolling out an operational excellence program in response to a cost reduction crisis is a little silly. It’s like seeing your house on fire and responding by mowing the lawn, or having your car battery die and responding by installing cup holders, or realizing your boat is sinking and responding by waxing the rail.

Changes to USP chapters have been implemented and more will be taking effect soon. These changes impact the routine operations of pharmaceutical and biopharmaceutical companies as well as those of their contract services and outsourcing partners.

Contract manufacturing covers a wide landscape, from development to clinical supplies, Active Product Ingredients (APIs) to medical device components, and intermediate and final product manufacturing. So what does it take to be a successful contract manufacturer? In a nutshell, a mature and well defined technical transfer process.