Manufacturing

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.

Thermo Fisher Scientific adds Advanced Scientific’s custom single-use systems and equipment to its bioprocessing offerings.

Aesica announced that it received continuing approvals from FDA for its bulk manufacturing and packaging operations in Germany.

The Shantha facility will be Sanofi's second, in addition to its site in Frankfurt, for production of Insuman insulin.

The pharmaceutical supply chain continues to be a challenge for the industry despite advances in QbD and PAT.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

Tooling can be damaged by poor handling or problems in process design or material choice.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.