Emergent BioSolutions, ProMetic Life Sciences Set Manufacturing Agreement
ProMetic Life Sciences will use manufacturing and plasma fractionation processes at Emergent BioSolutions’ Winnipeg, Canada facility.
Theorem Opens Clinical Supplies Facility
Clinical supplies facility in Frankfurt, Germany will triple Theorem Clinical Research’s current clinical supplies capacity.
Titration Systems Configured for Single-Analyte Testing
Potentiometric titration systems from Metrohm can be customized for different applications.
Aseptic CMO Recognized as Company to Watch
Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.
Kit Detects and Quantifies HCPs
Gyrolab CHO-HCP Kit 1 detects and quantifies host cell proteins from Chinese hamster ovary cells.
A New World for Pharma Regulations?
The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.
Small-Molecule APIs Still Play a Big Role
Despite the buzz about biologic-based drugs, small molecule-based drugs are still the mainstay treatment.
CMOs in Asia Gain Market Share, Slowly
While biomanufacturing clusters continue to emerge outside of North America and Western Europe, they are unlikely to threaten these powerhouse CMOs.
Safety Testing on the Manufacturing Floor
New test methods can streamline drug development by bringing safety testing of raw materials directly to the manufacturing floor.
Advances in Continuous Crystallization
Research groups supported by industry tackle the challenges of continuous crystallization and process analytical technology.
Keeping Up with Biologics Advances
The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.
Intertek Opens GMP Pharmaceutical Stability Storage Facility in Cambridge, UK
This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.
EMA Upholds GVK Biosciences Suspension Recommendation
EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.
CMC Biologics Expands Denmark Facility
The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.
Symbiosis Launches Bulk Lyophilization Service
Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.
SAFC Expansions Address Significant Need for Enhanced Manufacturing Capabilities
SAFC’s new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.
Rx-360 Establishes Working Group in India
Supply chain consortium establishes a working group to address quality problems in India.
Moving Forward with Serialization
A complex and evolving set of regulations challenges drug manufacturers to understand and implement serialization requirements.
