By Charlie Neal, Area Manager, Southeast Region, ProPharma Group
Ever wonder why some — most — projects don't go as planned? Let me take a cut at explaining what I have observed in the last few decades. Firstly, let us assume that you have contracted a well-known consulting firm to assure that you reach the established key milestones. Let us also assume that a Contract Manufacturing Organization (CMO) has agreed to contract process validation services. In particular, the CMO needs support validating the process for a new product. In addition to process validation, this firm will also need to have cleaning validation performed to verify that there are no detrimental residues of this new product left on common processing equipment.
By Sergio Mauri, Manager, BU Integrated Projects, Fedegari Group
The blockbuster model that was driving the pharmaceutical manufacturing industry in the past several decades has almost ended. Massive production, large batches, and high-speed lines have been designed to supply the patients with “multipurpose” small molecule drugs to cover the huge worldwide demand of health for the most common diseases. The next-generation drugs will focus on the single patient and bespoke to cover the individual health demand. For instance, biotech products and large molecules are the most promising therapeutic means for treatment of different kinds of cancer.
By Chris Rombach, ILC Dover
Media and buffer preparation is a key part of the biopharmaceutical manufacturing process, and while it doesn't need 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.
• Who should attend? Pharma and biopharm executives who form and manage outsourcing partnerships.
• What's on the agenda? Educational sessions focused on best practices and industry leaders’ experiences and lessons learned to help you avoid costly mistakes.
Register today! Space is limited. Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.