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.
>> Read More
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
Biopharma 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
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