Sourcing and Management by Pharmaceutical Technology
November 2014 Volume 10 Issue 11

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In this issue: News, interviews, and articles on industry efforts to secure the supply chain, consolidation of contract outsourcing providers, advances in contract analytical testing and biologics development, API development challenges, and business news.

Featured Content
Mission: Close Gaps in the Supply Chain
By Cynthia A. Challener, PhD
Supply chain security and quality group Rx-360 driven by patient safety.
>> Read More

Outsourcing
CMO Exits Reduce Pharma Manuacturing Capacity
By Jim Miller
As the number of CMOs shrinks due to acquisitions, exits, compliance problems and a switch to proprietary products, the capacity available to industry is reduced.
>> Read More

Analytical Testing Advances Deliver More Data
New assays, as well as advances in mass spectrometry and chromatography, give analytical testing laboratories tools to provide drug sponsors with additional information.
>> Read More

Advances in Technology Needed to Spur Biologics Growth
Technologies, such as high-throughput screening and single-use systems, are facilitating the development and manufacture of large-molecule drugs.
>> Read More

API Synthesis & Manufacturing
GMP Fluorination Challenges Limit Use in API Synthesis
By Cynthia Challener, PhD
Fluorination can significantly impact the bioavailability of drug substances, however, safer fluorinating reagents and access to GMP fluorination capabilities remain challenges.
>> Read More

Regulatory Developments
WHO Promotes International Collaboration for Generic Drug Approvals
By Sean Milmo
The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.
>> Read More

Business
Pharma Industry Growth Slows in Brazil
By Hellen Berger
The Brazilian economy is being impacted by internal and external factors, and forecast figures are being quickly revised downwards.
>> Read More

Outsourcing Association Elects Chairman
Industry veteran Peter Bigelow to guide PBOA Board.
>> Read More

Contract Services Roundup
LabCorp to Acquire CRO Covance

BMS Expands Manufacturing Agreement with Lonza

SGS Completes Cell Bank Testing Facility

DPT Expands Capacity with New High-Speed Bottle-Filling Center at San Antonio Site

MPI Research Acquires Jasper Clinical Research & Development

BioReliance Adds Advanced In-Vitro ADME and Toxicology Services

Ashland Opens a Pharmaceutical Center in Delaware

Industry News
Gerresheimer Introduces Integrated Processes for Mold Qualification

FUJIFILM Announces Agreement to Acquire Kalon Biotherapeutics

Webcasts
Developing a Comprehensive Tool Kit for Microbial Identification
Tuesday, November 18, 2014 at 8:00 AM PST/ 11:00 AM EST/ 4:00 PM GMT/ 17:00 PM CET
Sponsored by Eurofins Lancaster Laboratories