Grand River Names Director of Manufacturing
Steve Nole joins Grand River Aseptic Manufacturing as director of manufacturing.
WellSpring Pharma Services Names New President
WellSpring Pharma Services has announced the appointment of David Mayers as president.
Repligen Expands US Manufacturing Facility
A facility expansion adds space for production of Repligen’s tangential flow system.
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.
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.
Modest Expectations for CMOs and Biosimilars
Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.
FDA Tightens Drug Security Regulations
New rules for tracing drugs through the supply chain and policies for drug compounders change the regulatory landscape.
Mitigating Cold-Chain Risks
Market growth, costs, and regulations, and drive pharmaceutical companies to find new ways to mitigate risk in the cold chain.
The Challenge of Resolving Agents for Chiral Resolution
Finding efficient methods for the production of chirally pure APIs remains an important topic in the pharmaceutical industry,
Catalent Expands Clinical Packaging Capabilities in Europe
The company has increased capacity for cold storage and controlled drug substances handling at its European facilities.
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.
PCI Completes Full Biotec Rebranding
Five months after PCI acquired Biotec International Services , PCI has completed a complete rebranding of the UK-based Biotec.
Romaco Group Announces Finalization of Innojet Acquisition
Romaco Group announced that it had finished the acquisition of Innojet Herbert Hüttlin, a German company specializing in coating and granulation.
AmeriSourceBergen Adds New Distribution Center in Australia
The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.
Significant Changes in the 2014 IPEC Significant Change Guide
A revision and modernization of the IPEC Significant Change Guide incorporates concepts of risk assessment.
