PTSM: Pharmaceutical Technology Sourcing and Management-06-03-2015

ProMetic Life Sciences will use manufacturing and plasma fractionation processes at Emergent BioSolutions’ Winnipeg, Canada facility.

Clinical supplies facility in Frankfurt, Germany will triple Theorem Clinical Research’s current clinical supplies capacity.

Potentiometric titration systems from Metrohm can be customized for different applications.

Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.

Gyrolab CHO-HCP Kit 1 detects and quantifies host cell proteins from Chinese hamster ovary cells.

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.

Despite the buzz about biologic-based drugs, small molecule-based drugs are still the mainstay treatment.

While biomanufacturing clusters continue to emerge outside of North America and Western Europe, they are unlikely to threaten these powerhouse CMOs.

New test methods can streamline drug development by bringing safety testing of raw materials directly to the manufacturing floor.

Research groups supported by industry tackle the challenges of continuous crystallization and process analytical technology.

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.

The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.

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’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.

Supply chain consortium establishes a working group to address quality problems in India.

A complex and evolving set of regulations challenges drug manufacturers to understand and implement serialization requirements.