Manufacturing

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.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.Roche Acquires Bispecific Antibody Developer Dutalys

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

MedicalRF.com/Science Photo Library-ANDRZEJ WOJCICKI/Henrik Jonsson/Stocktrek Images; Dan Ward

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

Tosoh Bioscience’s CaPure-HA hydroxyapatite chromatography resin is designed for the purification of monoclonal antibodies, polyclonal antibodies, and antibody fragments, and the separation of antibody isoforms and isozymes.

Opdivo and investigational agent FPA008 will be tested in combination for their efficacy in boosting antitumor immune response.