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.
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.”
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.
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.
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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.
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.