12.09.13 -- NovoNordisk's New Diabetes Drug, Ferring Research Institute: Benefits Of Peptides, And More
The Microsart AMP Mycoplasma utilizes quantitative, real-time PCR as the method of choice. The kit is EP 2.6.7 and EP 2.6.21 compliant and is suitable for sensitive and robust detection of Mycoplasma contaminations for different raw materials in a biopharmaceutical process. With the ability to be very flexible in sample volume and sample preparation, the kit is specifically designed for the control of fermentation materials, for in-process controls, and for lot release testing of finished products. Learn more.
By Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader
Dr. Keith James joined Ferring Pharmaceuticals as VP of therapeutic innovation in early 2012. In December, 2012, he was promoted to president of the Ferring Research Institute and SVP of R&D for Ferring Pharmaceuticals. Prior to joining Ferring, Dr. James spent 29 years working for Pfizer, with significant time spent in discovery research. At the 2013 Oligonucleotide & Peptide-Based Therapeutics Congress he will speak on recent progress and future prospects in the peptide and protein therapeutic space. I recently spoke with Dr. James to get an overview of the potential in this market.
A Q&A With Christophe Couturier, VP of Services, Merck Millipore
The challenge of getting your drug product to clinical trials is expensive and time-consuming. This portion of the drug development pipeline could take an average of 18 months to complete — not to mention the sizable investment in facilities and labor. How can pharma and biopharma manufacturers keep new, innovative drugs in the pipeline, and still cut down on those big risk factors?
By Richard Mirro, Eppendorf Inc.
This application report presents a simple protocol for achieving high-density culture of Pichia pastoris (P. pastoris) cells using a New Brunswick benchtop autoclavable stirred-tank fermentor or bioreactor.
By Darrick Niccum, Senior Global Product Manager - Biotechnology, TSI Incorporated
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of RMM instruments.
By Brent Bushnell, Colder Products Company
When the first sterile connectors were launched, in the early 2000s, single-use systems and bioreactors were focused on small-scale production at the lower end of the pilot-plant range. Maximum single-use bioreactors ranged from 200L to 500L, and although sterile hold bags of 1000L to 2000L were used, flow rates of 20L per minute were sufficient in most cases. Sterile connectors designed around 1/2" I.D. formats performed well for the majority of single-use applications at that time.
By Michael Gotz, QuickSTAT
In the previous blog post "Infectious Biologicals Category A and B — Classification Guidelines", I provided definitions of infectious biologicals Category A and B, and some basic guidelines on how to classify your shipments. These definitions are clear and helpful when you know that your shipment contains pathogens. In that case, it is either on the list for Category A, or if it is not, then it is classified as Category B.