Newsletter | March 12, 2014

03.12.14 -- FDA Overhauls Non-Prescription Drug Approval Process

Bioresearch Online Newsletter
Quality/Regulatory Downstream Upstream Supply Chain Integrity
» Featured Article
4 Ways You Can Overcome Roadblocks To Technology Adoption In Clinical Trials
By Shannon Cooke, Project Manager, Life Science Solutions, TransPerfect Life Sciences
Technology continues to advance at almost breakneck speeds. Not only are these advancements surpassing anything we could have imagined just 10 or 20 years ago, they are touching every professional field, including Life Sciences. More advanced computers, displays, and software programs are replacing paper, cards, files, and binders in libraries, banks, and professional offices around the world. Yet despite a clear need and desire to move in a paperless direction, clinical trials still lag far behind other highly regulated industries.
Featured Focus: Quality/Regulatory
Strategies For Gamma Sterilization Of Pharmaceuticals
By Ruth Garcia, Betty Howard, Rose LaRue, Glenn Parton, and John Walker, Steris Isomedix Services
A crucial step in pharmaceutical production is sterilization. There are many sterilization methods to choose from such as steam, sterile filtration, ethylene oxide gas (EtO), electron beam (E-beam), and gamma radiation. Each technique has aspects that make it suitable or unsuitable for the sterilization of a particular product.
WHITE PAPER: 21 CFR Part 11 Challenges And Solutions
CASE STUDY: EDC Versus Paper: A Head To Head Comparison
BROCHURE: Arc Conductivity Sensor For Pure And Ultra-Pure Water 
BROCHURE: Improve Bioavailability With SoluPath A Multiplatform Solution
BROCHURE: Laser Diffraction Particle Size Analyzer
PRODUCT: Low-Temperature Sterilization System: Amsco V-PRO 1 Plus
» Downstream
WHITE PAPER: Bioterrorism Countermeasures: Vaccines
By Dr. Laura Ciccolini, Commercial Director, Biopharma Technology Limited
There have been few instances of bioweapon use by terrorists, but the impact has been significant. With the growth of political turmoil and of extremists groups, the potential danger of bioterrorism is increasingly in the minds of the public and governments.
WHITE PAPER: Faster Flash Purification Of Peptides With Higher Loading And Better Resolution
By Bopanna N.K., Chitra Sundararajan, and Melissa J Wilcox, Grace Discovery Sciences
Peptides and proteins are becoming increasingly popular for their potential use as therapeutic drugs. To earn and maintain a share in the fast-growing peptide market, peptide researchers and manufacturers are constantly trying to improve and optimize the various steps in peptide synthesis.
DATASHEET: Foresight Prepacked Plates And Columns 
By Bio-Rad Laboratories, Inc.
DATASHEET: ÄKTA Pure Chromatography System For Fast Purification
By GE Healthcare Life Sciences
PRODUCT: ArmorFlex 114 Film: Containment Solution
PRODUCT: BalanCD Chemically Defined Growth And Feed Media Product Line
PRODUCT: Seed Expansion And Cell Banking System
» 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?
ARTICLE: Boost Efficiencies In Bioprocessing Workflows With A CIMS
By Gail Dutton, DASGIP Information and Process Technology GmbH, an Eppendorf company
For many bioprocessing professionals the proliferation of process monitoring and control solutions presents an immense opportunity to improve their knowledge of their mammalian cell cultivation or microbial fermentation processes.
DATASHEET: Allegro MVP Single-Use Bioprocessing System
By Pall Life Sciences - BioPharmaceuticals
DATASHEET: Amyloid Beta-Protein Immunohistostain Kit
By Wako Laboratory Chemicals
BROCHURE: Fibra-Cel Disks Support System For Cell Cultures
POSTER: Different Responses Between Human Primary Cells Cultured In 2D vs. RAFT 3D Cell Culture System
PRODUCT: Aegis 5-14 Film: Single-Use Container System
» Supply Chain Integrity
ARTICLE: Why Monitoring Cold Chain Data Is Not Enough
By Nitin Dahad, Dyzle
In the cold chain logistics industry there's a huge change happening. Lots of data is being gathered by wirelessly connected data loggers, sensors, and monitoring equipment. This is sometimes referred to as real-time monitoring or "near-real-time" monitoring. Having all this information is great, and this may contribute to GDP and GMP guidelines for food and pharmaceutical industries, but having too much data may also pose challenges if not managed properly.
ARTICLE: Securing The Brand Packaging Workflow
ARTICLE: Clinical Trial Logistics In India: Managing Distribution Timelines Through The Efficient Importation Of Investigational Drugs
CASE STUDY: Why Air Cargo Is A Viable Solution For Transporting Medical And Pharmaceutical Products
By Todd Keefe, Southwest Airlines Cargo
The ecosystem tied to the movement of medical and pharmaceutical products is complex and highly distributed. Shippers and receivers for these life-saving products are spread out around the country, and there are no centralized routes between them.
CASE STUDY: Precise Cold Chain Logistics Supports Global Study Of Heart Disease
» Most Recent News
FDA Overhauls Non-Prescription Drug Approval Process
Eisai And Biogen Idec Collaborate Over Alzheimer's Disease Drugs
GE HealthCare Invests In Blood Cancer Testing Technologies
Merck's MK-5172/MK-8742 Treatment Shows Anti-HCV Efficacy
Stem Cells Driving Alzheimer's Research
IBC's Biopharmaceutical Development & Production (BDP) Week event (March 24 to 27, 2014, San Diego, CA) provides the most in-depth coverage of bioprocessing methods in the field to give you the tools you need to develop and manufacture the increasingly diverse and complex molecules emerging in the biopharmaceutical pipeline. New registrations can save 20 percent off the standard rate with priority code BDP14BRO. Download the event brochure.

HIPAA And Source Data Access: Dispelling The Myths
Date: Friday, March 14, 2014 • Time: 1pm – 2:30pm EST

Vendor Qualification And Compliance: What Sponsors And CMOs Must Know
Date: Tuesday, March 25, 2014 • Time: 1pm – 2:30pm EST

Computer Systems Validation (CSV) — Avoiding The Top Five Regulatory Pitfalls
Date: Wednesday, April 9, 2014 • Time: 1pm – 2:30pm EST
Follow Bioresearch Online: