Newsletter | January 6, 2020

01.06.20 -- A Biopharma Year In Review -- And A Look Ahead To 2020

Featured Editorial
A Biopharma Year In Review — And A Look Ahead To 2020
By K. John Morrow, Jr. and Eric S. Langer

The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.

Executing Signals And Responses In A Continued Process Verification Program
By Peiyi Ko, Ph.D., founder and consultant, KoCreation Design LLC

Part 1 of this series provided an overview of continued process verification (CPV) and how it is key to setting the foundation for continuous improvement in pharmaceutical manufacturing. In this second part we will look more deeply into how enhanced knowledge management can enable robust change management in the life sciences industry.

Industry Insights
Can You Trust A Machine For Downstream Bioprocess Buffer Preparation?
Article | By Enrique Carredano, GE Healthcare Life Sciences

There is a limit to how many stainless-steel tanks you can squeeze into a biomanufacturing facility. Is automated buffer preparation a solution to the dilemma of balancing increased production capacity against limited footprint expansion alternatives?

Should You Choose A Commercial HPAPI Manufacturer For Your Clinical Program?
White Paper | By George Hlass and David Bastie, FAREVA

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. Partnering from the outset with a CDMO capable of supporting HPAPI projects from concept to launch can accelerate development timelines and reduce overall costs.

Analytical Quality By Design Using Design Of Experiments
Poster | By Lun Xin, James Crichton, Spencer Beard, Wei Hong, Yao Chen, Todd Stone, and Yunsong Li, Catalent

At the center of analytical quality by design (QbD) is design of experiment (DoE). Using DoE, assay development begins with the creation of an analytical target profile to define method objectives including critical method attributes and key method attributes. This scientific poster demonstrates how a panel of analytical assays designed for a mAb used different DoE approaches for rigorous statistical design and analyses for assay development.

Comparator Sourcing In Emerging Markets: Look Before You Leap
Article | Thermo Fisher Scientific

The broad appeal of emerging markets for comparator sourcing is offset by the innumerable challenges that can arise in such regions. But, companies can minimize risks and avoid common pitfalls.

Continuous Flow Manufacturing Of Pharmaceutical Ingredients
White Paper | Ajinomoto Bio-Pharma Services

While batch process chemistry remains the standard in the pharmaceutical industry, a clear increase in continuous flow processes has emerged over the past decade thanks to the commercialization of preparative flow reactor units. A strong growth is anticipated for continuous flow manufacturing of active pharmaceutical ingredients as it offers a number of important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

Quick To Clinic For Oral Solid Dose
Thermo Fisher Scientific
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