Manufacturing

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.

As more biologic drugs come to market, manufacturers will require improved bioprocessing technologies.

Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.

The authors review efforts to limit polymer degradation without significantly impeding cell growth.

Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.