Sourcing and Management by Pharmaceutical Technology
September 2014 Volume 10 Issue 9

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In this issue: News, interviews, and articles on advances in outsourcing relationships, biopharma business opportunities in Africa, meeting regulatory requirements for supply chain safety, and other business news.

Outsourcing
Contract Services Ride High As Funding Floods Bio/Pharma
By Jim Miller
The contract services industry’s success is largely a result of the improved financial environment, rather than an increased acceptance of outsourcing.
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Contract Providers Assume Expanded Responsibilities
By Rita Peters
Contract service providers are playing a more diverse role in drug development.
>> Read More

Study: CMO Technical Expertise is Not Enough
By Eric Langer
Sponsors are demanding high levels of professionalism, performance, and effectiveness in managerial areas to accompany CMOs’ technical expertise.
>> Read More

Business
African Biopharma Market Presents Long-term Opportunities
By Cynthia A. Challener, PhD
http://www.pharmtech.com/pharmtech/sitewide/images/clear_dot.gifBiopharma companies seeking to leverage opportunities in African market must adopt the right strategy to achieve success.
>> Read More

FDA Strategies Designed to Speed Generic Drug Approvals
By Jill Wechsler
A surge in generic drug applications is testing FDA’s ability to reduce the backlog of ANDAs.
>> Read More

Supply Chain
Preparing to Meet Counterfeiting Regulations
By Jennifer Markarian
An expert discusses how companies should be preparing to meet the requirements of the Drug Supply Chain Security Act, which requires phase-in of requirements to prevent counterfeiting.
>> Read More

API Synthesis and Manufacturing
Supply Chain Security Tops Concerns for Biopharma Raw Materials
By Cynthia A. Challener, PhD
Biopharma are looking to reduce risk, increase performance, and optimize productivity in raw material development.
>> Read More

Contract Services Roundup
DPx Holdings Acquires Gallus BioPharmaceuticals

WuXi Facility Passes FDA Inspection for Manufacture of API

Fujifilm Diosynth Biotechnologies Expands Cell-Culture Capacity

Catalent Appoints Two Executives to Board of Directors

PSC Investments Acquires Sterile Injectable Fill/Finish Facility

Gallus to Manufacture Anti-PSMA mAb for Progenics Pharmaceuticals

Industry News
American Airlines Cargo Builds Pharmaceutical Handling Facility

EMD Millipore Signs Contract with Samsung BioLogics

GE Healthcare Life Sciences Announces New US Headquarters in Massachusetts

Webcasts
API Characterization for a Speedy and Successful Formulation Strategy
Thursday, Sept. 18, 2014, 8:00 am PDT/ 10:00 am CDT/ 11:00 am EDT
Sponsored by Patheon

Worry-free weighing: Dealing with static and drafts
Thursday, Oct. 9, 2014, 11:00 am EDT
Sponsored by Mettler Toledo

Accelerating Vaccine Development: Regulatory, Biosafety, and Clinical Strategies
Tuesday, Sept 9, 2014 at 11:00 am EDT for the US, Tuesday, Sept. 16, 2014 at 15:00 CET
Sponsored by SGS Life Science Services

Utilizing PepFinder Software for Interrogation of LC-MS Peptide Map Data of Biotherapeutics
Wednesday, Sept. 17, 2014 at 8:00 am PDT/ 11:00 am EDT/ 4:00 pm BST/ 5:00 pm CEST
Sponsored by Thermo Fisher Scientific