• 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.
By Wayne Koberstein, Executive Editor
You have seen the headlines, reading them like obituaries for the about-to-be departed. You know the drill: repeated failures in Phase 3, nothing to replace the big earners with vanishing patents, mental images of a ship lost at sea. So why is Eli Lilly & Company still here — sailing the same course, undiverted, undiluted, and seemingly undeterred as the uniquely independent Midwestern-based company it has always been?
By Vinnie Hebert, Product Manager, Brookfield Engineering Laboratories, Inc.
Nutraceutical powders are like pharmaceutical powders in many aspects. There is an active ingredient (or ingredients) with a host of excipients.
By Mike Byrd, Director of Computer System Validation, ProPharma Group
While documented cost estimates may vary for correcting software/system defects in early versus late phases of the life cycle (10 to 100 times), the fact remains that formalized design verifications can be an effective tool in improving software quality. In regulated environments this can translate into improved compliance, enhanced data integrity, and ultimately. patient safety.
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, more efficient, protects personnel, and could cut time and costs as well.
By Annette Kaya, Andrea Uebele, Anke Seeger, et al., M+W Process Industries
Contract manufacturer DSM Biologics, at its current good manufacturing practices (cGMP) facility in Groningen, The Netherlands, provides services for clinical development and commercial production based on mammalian cell culture technology.