Newsletter | October 19, 2012

10.19.12 -- What Should You Do When Your CMO Gets Bad News From The FDA?

Pharmaceutical Online
What Should You Do When Your CMO Gets Bad News From The FDA?
By Wayne Koberstein, contributing editor, Life Science Leader
Dr. Brian James, Ph.D., VP of operations, Rondaxe, gives his insights on the best course of action for a pharmaceutical company to take when the CMO faces regulatory problems.
Read more.

Are you frustrated by corrosion problems? CSI stocks complete lines of corrosion-resistant superalloy fittings and tubing in AL-6XN and Hastelloy C-22. Our extensive inventory and three locations enable us to ship hygienic piping and components around the globe in a timely manner. Learn more.

Outsourcing Articles

The Impact Of DMPK Clinical Failures
By John James Vrbanac, MPI Research
Integrating DMPK studies early in the drug development process can significantly decrease attrition rates. Read more.

Collaboration Can Lead To A True Extension Of Your Own Supply Chain
By Luc Ruelens, senior director for external supply integration, Asia Pacific, Janssen Supply Chain
Janssen collaborated with CMOs in Asia to achieve their goal to develop a few preferred partners for early API synthesis steps. Read more.

Top Mistakes Made By CMOs And Their Clients
By Eric Langer, president and managing partner, BioPlan Associates, Inc.
When choosing outsourcing partners, there are 19 factors that affect biotherapeutic developers' selection of CMOs, according to the 9th Annual Report and Survey of Biopharmaceutical Manufacturers. Read more.

Featured Multimedia
Video: Center Of Excellence For Sterile And Specialty Products

Video: Center Of Excellence For Sterile And Specialty Products

The 175,000 square foot Center of Excellence for Sterile and Specialty Products, in Lakewood, NJ, focuses on aseptic production of sterile dosage forms.

Featured Webinar

Driving Innovation In A Collaborative Biopharma Ecosystem
Round table discussions with:
Greg Verdine, Venture partner of Third Rock Ventures, Erving professor of chemistry at Harvard University, founder of Warp Drive Bio
Mike Varney, Senior vice president of small molecule research, Genentech
Joe Vacca, Senior vice president, early success sharing partnerships, WuXi AppTec
Chris Chen, Senior vice president and CTO, biologics services, WuXi AppTec
Moderated by Richard Soll, Senior vice president of integrated services and head of corporate alliances, WuXi AppTec
Click here to register. Learn more.

Featured Outsourcing Solutions
CGMP Radiosynthesis: Will Your CRO Be There When It Counts?
Expert 14C radiolabeling for human clinical programs requires extensive training and experience. Having supported radiolabeled studies for more than 10 years, ABC Laboratories was one of the first to synthesize 14C-labeled API and formulate to prepare drug product under CGMP. Read more.
Focus On Content Uniformity Via Flow Control Systems
With a focus on improving outcomes for patients, Norwich discovered a content uniformity issue during the technical transfer of a low-dose product and then provided a novel solution to ensure reliable product supply.  Read more.
Poster: Enhancing The Solubility Of Poorly Water-Soluble Drugs In The Presence Of Nano-Emulsion Particles
By DPT Laboratories
Aqueous solubility of drug substances is an important parameter in preformulation studies of a drug product. Several drugs are sparingly water-soluble and pose challenges for formulation and dose administration. Read more.
Fact Sheet: Jubilant HollisterStier Overview
Jubilant HollisterStier Contract Manufacturing & Services is an integrated pharmaceutical contract manufacturer, able to manufacture sterile and nonsterile dosage forms. Read more.
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