Newsletter | December 9, 2013

12.09.13 -- NovoNordisk's New Diabetes Drug, Ferring Research Institute: Benefits Of Peptides, And More

Bioresearch Online Newsletter
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.
» Guest Column
Peptides And Proteins Make Significant Advances
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.
Upcoming Training

Clinical Investigator Meeting Training: No GCP 101, Please!
Date: Tuesday, December 10, 2013 • Time: 1pm – 2:30pm EST
Featured Focus: Upstream
Q&A: Cutting Time And Cost In Getting Your Drug To Clinic
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?
White Paper: Analysis Of Dialyzed Flask Technology For Antibody Production
By Denis Phichith, Ph.D. and Brian Canna, MBA
Efficient and cost-effective hybridoma culture is essential to small- and large-scale monoclonal antibody production for research purposes.
Application Note: Introduction To Pichia Pastoris In A Stirred-Tank Fermentor
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.
Datasheet: T-Series Membrane Cassettes
By Pall Life Sciences - BioPharmaceuticals
Product: Mix-Mode Chromatography Media
Product: WeighStation: Quantitative And Reproducible Fluid Measurement
Product: Fiber Optic Raman Spectrometer: AvaRaman
» Quality/Regulatory
White Paper: The Challenges With Real-Time Viable Particle Counters
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. 
White Paper: How To Successfully Manage Your Suppliers And Ensure Product Safety And Compliance
Application Note: Improve Compound Purification Efficiency And Productivity At Minimal Costs
Catalog: Liquid Handling Solutions
Brochure: Versatile Cell Counter And Analyzer: Multisizer 3
Service: Isomedix Tissue Processing Services
Product: CrimpLoc Closure System
» Downstream
Article: The Demand For High-Flow Sterile Connectors For Single-Use
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.
Article: Supporting Advances In MAb Process Development And Manufacturing
Datasheet: HVAC Filter A11 Mini-Pleat With Gasket
By 3M Purification
Brochure: DHX Disposable Heat Exchanger
Brochure: Cytotoxic Services: Safe And Responsible Handling Of Cytotoxic Drugs
Brochure: Sani-Tech High-Purity Piping And Components
Brochure: Sample Dryer: SampleGenie
» Supply Chain Integrity
Guest Column: Dangerous Goods Classification: UN 3373 Biological Substance, Category B Confusion
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.
Case Study: IMP Shipments: Too Big, Too Costly, Too Bad
Case Study: Quick International's Reliable Cold Chain Solution To Deliver Medical And Pharmaceutical Products
Datasheet: Aeris Pallet Shipper
By ThermoSafe, Sonoco Protective Solutions
Brochure: Asset Tracking And Cargo Condition Monitoring Unit: SC506S
Brochure: Xyntek-Antares Bottle Tracking System
» Most Recent News
NovoNordisk Drug Demonstrates Superior Blood Sugar Control
First FASN Anti-Tumor Candidate in Clinical Development
New EU Funding For Research Into Heart Disease
Smart Wound Dressing Could Help In Fight Against Drug-Resistant Bacteria