Manufacturing

The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.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

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

Sanofi will tap into Boehringer Ingelheim’s therapeutic monoclonal antibody manufacturing capabilities.

Single-use components aid efficiency in automated personalized therapy manufacturing.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

Switching grades of raw material late in the development cycle can be costly. Best practice says get it right at the beginning.

New designations lead to faster drug approvals, but there is more work to be done.