Manufacturing

The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.

While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.

Sessions address cell therapies, tableting, continuous processes, serialization, and more.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

Cleanability is crucial when choosing components for GMP manufacturing areas.

Several chromatographic resins are available for downstream purification.

Is there enough talent to go around?

It is vital that companies involved in the manufacturing and handling of cytotoxic drugs ensure that staff are given the highest possible levels of protection.

The company has increased capacity for cold storage and controlled drug substances handling at its European facilities.

Enclosures contain powders and particulates during hazardous drug manipulation.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

Aprecia Pharmaceuticals' new facility in Ohio will create 150 jobs.

Leased facilities in California will expand Kite Pharma's capacity for clinical T-cell therapies.

The agency cites Apotex’s Bangalore facility with quality system failures.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

Careful selection of a contract packager should include interviews, surveys, and on-site visits.

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

MG America's TEKNA Capsule Filler has advanced controls to reduce powder loss and maintain optimal performance.

Advances in process modeling and use of open-architecture control models will lead to more efficient process control methods.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

UPS Temperature True Packaging provides four prequalified packaging system options for temperature-sensitive products with different time and temperature requirements.

Changsung's Gel Reclaim System (GRS) recovers gelatin scrap from a soft gel line.