Manufacturing

Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

Is there enough talent to go around?

Scientists and industry experts seek effective preventive therapies to combat global disease.

Large-scale implementation of Protein A chromatography offers several challenges.

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Baxter announced that its new biopharmaceutical arm, scheduled to become independent from Baxter in 2015, will be located in Bannockburn, Illinois.

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

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

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.

The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.

Antibodies in research should be standardized and categorized using a barcode-like classification system, according to research published in Nature.

Juno's new manufacturing facility in Washington state will support clinical trials for immunotherapies.

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.

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

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

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

They may not be glamorous, but buffers play an important role in biopharma manufacturing.

As ADCs move through the drug-development process, different analytical methods are often required.

Evaluating the assembly design process, manufacture, and use helps mitigate risk.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Market forces may limit the success of CMOs.

The use of commercially available media to achieve high titer in early process development is discussed.

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.

The potential blockbuster treatment targets a protein involved in cholesterol homeostasis.

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.