Newsletter | January 8, 2020

01.08.20 -- Biotech Music In The "Twenty-Twenties"

From The Editor
Biotech Music In The "Twenty-Twenties"
By Louis Garguilo, chief editor, Outsourced Pharma

Welcome to the melodious-sounding “Twenty-Twenties.” What correspondingly pleasant harmonies will we hear from our drug industry during the second decade of this millennium? James Mackay, Ph.D., founder, president, and CEO, Aristea Therapeutics, and Stanley Crooke, M.D., Ph.D., founder, chairman, and CEO, Ionis Pharmaceuticals, predict a virtuosity emanating from the halls of biotech.

Featured Editorial
Nickels And Dimes: What To Do When Your CDMO Charges You Unexpected Fees
By Barbara Berglund, COO, CMC Turnkey Solutions

There are so many factors that figure into initial selection of a CDMO: You would consider capabilities, core competency, schedule flexibility, quality, and regulatory track record. You need to consider the cost of transferring in your process, your test procedures, your overall program, you need to set assumptions for costs associated with changing the timing of manufacturing dates, or you may find that there is a discounted price for campaigning several batches or if you manufacture a certain number of batches per year.

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

Process validation should never be performed until the process is fully characterized. A failed process validation should be a rare event; otherwise, a warning letter will probably be in your future.

Industry Insights
Doubling Up For Speed: Using Parallel Operations In Biopharma Manufacturing
Article | By Joe Makowiecki, Patrick McMahon, and Sven Frie, GE Healthcare Life Sciences

One solution to drug development challenges is adopting a parallel operations business model. This article offers recommendations for how parallel operations can be leveraged in a biomanufacturing strategy.

Rethink Aseptic Filling To Meet Pharma’s Challenging Requirements
White Paper | Singota Solutions

Rethinking aseptic filling from technology to process to service while meeting shifting market demands will help all participants in the pharmaceutical industry and ultimately help the smaller patient populations who need targeted therapies.

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