Pharmaceutical Online Newsletter
Departments:
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Drug Substance Production
Logistics
Clinical Development
Dosage Form Production
Primary Process Development
Packaging/Assembly
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Featured Focus: Logistics
3 Keys To Mastering The Life Sciences Supply Chain With 3PL
By Richard Beeny, cofounder and CEO, LifeScience Logistics
In the past, most pharmaceutical companies performed their warehouse and distribution services within their own facilities, with very few outsourcing these processes to third parties. The supply chain was much simpler then, essentially getting a product from point A to point B.
BROCHURE: An Affordable Way To Ship Temperature-Sensitive Cargo
PRODUCT: Containing The Costs Of Reuse
NEWS: New Cold Chain Complete Actively Monitors Two Temperature Thresholds
» Discovery Research
ARTICLE: Managing Cell-Based Potency Assays: From Development To Life Cycle Maintenance
By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity, and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).
» Clinical Development
ARTICLE: Considerations In Using Cyclodextrins As Solubilizers For Early Toxicology Studies
By Lisa Z. Crandall, MS, Velesco Pharma Services
Early-stage drug development can frequently be hindered by compound solubility and the need to deliver large doses to animals with as little vehicle toxicity as possible. Formulators have a powerful tool in the Cyclodextrin (CD) molecules; however there are several complicating factors that must be considered.
NEWS: Recipharm Supplies Clinical Trial Material For FDA Approved Phase IIb Study Sponsored By PledPharma
NEWS: Concert Pharmaceuticals Announces Completion of Enrollment in Phase 2 CTP-499 Clinical Trial
» Primary Process Development
WHITE PAPER: Expedite Development While Ensuring Successful Commercial Outcomes
By Darren Hassey, director, Quality Assurance, AMRI
As regulatory expectations continue to evolve in the area of pharmaceutical development, working with contract research and manufacturing organizations that couple execution experience with high-end technical capabilities and contemporary quality systems will ensure the most value from strategic partnerships and enhance a project's progress on its path toward commercialization.
» Drug Substance Production
WHITE PAPER: Streamlining The Biological Factory: Making A Better CHO Cell For Biopharma Production
NEWS: AMRI And Codexis Announce Technology Collaboration
» Dosage Form Production
ARTICLE: Getting To The Core Of CoreRx
By Ed Miseta, editor, Outsourced Pharma
CoreRx officially opened its new 35,000–square-foot facility in Clearwater, FL on January 17, 2013, and members of the Life Science Leader team were there. The process all began last August, and when you think about it, going from a 3,300-square-foot facility to something more than 10 times the size is a pretty big deal.
NEWS: Santarus Announces Commercial Launch Of UCERIS (Budesonide) Extended Release Tablets
» Packaging/Assembly
SERVICE: Custom Packaging And Pouching