Newsletter | December 2, 2019

12.02.19 -- Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)

Featured Editorial
Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)
By Herman F. Bozenhardt and Erich H. Bozenhardt

There are many ways to tackle pharmaceutical facility design, engineering, building, and production, and each plant has its own methods and culture. However, there are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” 

Process Characterization: The Foundation For Validation
By Mark Durivage, Quality Systems Compliance LLC

Process characterization is the foundation for process validation activities. Too often, validation activities fail due to the lack of process characterization using sound statistical and scientific methods, including design of experiments (DOE).

Industry Insights
Cell-Based Assays In A GMP Environment: Approaches For Clinical And Commercial Stability Studies
Webinar | By Ming Li, Ph.D., and Aryo A. Nikopour, Nitto Avecia Pharma Services

This presentation demonstrates that in vitro, cell-based assays are an indispensable tool to quantify the biological activities of, and to support the potency tests for, biotherapeutics.

Preparing For Your CDMO Selection Process
White Paper | Ajinomoto Bio-Pharma Services

Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Some companies, especially those with limited experience in the biopharmaceutical industry, may find themselves unprepared when it comes to beginning the search.

Enhanced Cold Chain Capabilities
Article | Thermo Fisher Scientific

Along with proficient monitoring and tracking resources, Fisher Clinical Services optimizes every level of the cold chain process to ensure the security of clinical trial supplies.

Ensuring The Efficacy Of Probiotic Products
Article | Ropack Pharma Solutions

There is growing interest among consumers in verifying that the dietary supplements they take are safe and efficacious. The concern over whether consumers are getting the product as it is described on the label is rooted in one vital and transformative fact: probiotics are living organisms that are highly sensitive to humidity and oxygen. 

BioProcessing Asia Conference In Review
E-Book | GE Healthcare Life Sciences

This e-Book provides an illustration of the cutting-edge presentations from BioProcessing Asia 2018, from the sustainability of biosimilars, to the regulatory climate in Asia, the challenges facing the international bioprocessing community, and the latest technologies for viral vector/vaccine production.

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