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Outsourcing
Modest Expectations for CMOs and Biosimilars
Jim Miller
Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.
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PBOA Supports Legislation to Protect FDA User Fees
The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.
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API Synthesis & Manufacturing
The Challenge of Resolving Agents for Chiral Resolution
Cynthia A. Challener
Finding efficient methods for the production of chirally pure APIs remains an important topic in the pharmaceutical industry.
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Supply Chain
Mitigating Cold-Chain Risks
Wanis Kabbaj and Dirk Van Peteghem
Market growth, costs, and regulations, and drive pharmaceutical companies to find new ways to mitigate risk in the cold chain.
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Regulatory Developments
Significant Changes in the 2014 IPEC Significant Change Guide
Kevin J. McGlue
A revision and modernization of the IPEC Significant Change Guide incorporates concepts of risk assessment.
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FDA Tightens Drug Security Regulations
Jill Wechsler
New rules for tracing drugs through the supply chain and policies for drug compounders change the regulatory landscape.
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Contract Services Roundup
WellSpring Pharma Services Names New President
WellSpring Pharma Services has announced the appointment of David Mayers as president.
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Novasep to Manufacture Celladon's Mydicar API
Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.
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Catalent Expands Clinical Packaging Capabilities in Europe
The company has increased capacity for cold storage and controlled drug substances handling at its European facilities.
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SGS Expands Biomarker Testing Capabilities at Poitiers Facility
SGS has invested in additional modules for its COBAS 6000 analysis system in a move to expand its biomarker analytical capabilities at its Poitiers facility in France.
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Grand River Names Director of Manufacturing
Grand River Aseptic Manufacturing has named Steve Nole as director of manufacturing.
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Supplier News
Repligen Expands US Manufacturing Facility

Romaco Group Announces Finalization of Innojet Acquisition

PCI Completes Full Biotec Rebranding

AmeriSourceBergen Adds New Distribution Center in Australia

Webcasts
Fundamentals of Spray-Dried Dispersion Technology
Live broadcast on: March 19, 2015 at 11AM ET
Spray-dried dispersion technology is a proven approach to improve the dissolution rate and bioavailability of low solubility compounds, and helps to bring new medicines to market. Attend this webinar to learn the fundamentals of spray-dried dispersion formulation selection, process development, stability, scale-up, and performance considerations.
Sponsored by Bend Research

Applying Water Activity to Pharmaceutical Technology
Live broadcast on: March 25, 2015 at 11AM ET
Learn basics of water activity and the role it plays in the chemical stability, microbial content, and physical properties of pharmaceutical products. Hear experts discuss compendial and regulatory requirements for water-activity determination, and practical applications of water activity in marketed pharmaceuticals.
Sponsored by Decagon Devices