Newsletter | January 9, 2019

01.09.19 -- China Biopharma: Recognizing The Past, Recasting The Future

From The Editor
China Biopharma: Recognizing The Past, Recasting The Future
By Louis Garguilo, Chief Editor, Outsourced Pharma

In part two of our discussion with BeiGene’s Diana Francis, VP Quality & Compliance, we turn her attention back to two concerns with China: IP theft and quality breaches. Then I’ll wrap up our overall discourse to date, with two observations on what we’ve learned this past year about China’s growing connection to the global biologics industry.

Featured Editorial
5 Questions To Ask Your CDMO: #4 — What’s Your Sweet Spot?
By Bernhard J. Paul, Ph.D., Principal Consultant, Carinth Consulting LLC

While many companies (or company sites) have experience with early-phase work, it’s important to dig a bit deeper during your vendor selection due-diligence activities to understand what certain companies do best — their “sweet spot.”

Quality Risk Management And The Draft Annex 1 Revision: What To Expect
By Hal Baseman and Kelly Waldron, Ph.D., ValSource, LLC

The PIC/S Inspectors Working Group is preparing to finalize the EMA Annex 1, Manufacture of Sterile Medicinal Product, guidance/GMPs. The revision, an overhaul of the 2008 version of the annex, attempts to clarify many issues and concerns specific to aseptic processing of sterile medicinal products.

Industry Insights
Services Marketing: You Can’t Build A Strong Marketing Strategy On A Weak Foundation
Article | By Kevin Olson, Industry Standard Research, ISR Reports

Strong marketing service strategies are built on a strong foundation of deeply understanding the market, customer needs, and the decision-making processes. Continue reading to learn how to elevate your organization’s credibility and service marketing plans.

Utilizing External Collaboration To Accelerate Vaccine Development
White Paper | By Chris Rode, scientific director at Janssen Biotherapeutics Development

Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule Team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.

Route Scouting In API Development: A Luxury Or Necessity?
Article | Piramal Pharma Solutions

Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus, a new field of chemistry called process research was born.

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions
White Paper | Patheon

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

Elemental Impurities Tool Kit
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