INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Understanding The Physical Properties Of An API And Their Effect On Drug Product Performance

  An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.

• Expanding Sterile Crystallization Capabilities To Meet Rising Customer Demand

  Production of sterile powders requires specialized expertise and capabilities in sterile crystallization. Learn what your CDMO capabilities should be in order to deliver a quality product.

• Can You Afford Not To Outsource Buffer Preparation?

  The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

• Process Characterization: Ready For The FDA?

  In this webinar, Greg Sears, Ph.D, Global Director, Process Characterization, Head of Manufacturing Science and Technology, Pharma Services, Biologics at Thermo Fisher Scientific, discusses process characterization basics, including information on what’s optional vs. what’s required.

• Meet Aggressive Timelines By Simplifying Your Drug Delivery Supply Chain

  To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route for drug substance, drug product, and clinical trial packaging needs.

• Strategies To Develop Lipid-Based Drug Delivery Systems And Oral Dosage Forms

  Liquid-filled capsules (LFC) are the primary delivery platform for oral delivery of lipid formulations which includes both softgels and liquid-filled hard capsules. Liquid-in-bottle is another avenue for delivering lipid formulations. Proper deployment of these technologies can provide formulators with effective delivery platforms during early-phase development and commercial products. In this webinar, industry experts discuss strategies to develop lipid-based drug delivery systems (LBDDS) for oral delivery. The experts share the fundamental principles, advantages and disadvantages of different dose forms for LBDDS and considerations for selecting a suitable dosage form for early phase development programs through commercialization.

• Why Choose A Commercial HPAPI Manufacturer For Your Clinical Program?

  Switching from an early-phase CDMO to a commercial-scale manufacturer for your highly potent active pharmaceutical ingredient (HPAPI) projects can be costly and lead to project delays.

• Continuous Flow Manufacturing Of Pharmaceutical Ingredients

  Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

• Choosing The Right CDMO For Late Phase Clinical Trials

  For many pharmaceutical companies that do not have their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical aspect in the management of parenteral products. This webinar offers insight into the importance of looking for a partner with extensive experience in the parenteral arena, as products move through clinical phases and toward commercialization.