Development

Ligand-binding assays are fundamental to characterizing biosimilars.

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

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

Halozyme will receive an initial payment of $15 million for Enhanze, its technology that enables biologics to be delivered as a simple subcutaneous injection.

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

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

Merck announced an agreement with NewLink Genetics to acquire exclusive rights to its experimental Ebola vaccine, rVSV-EBOV, for $50 million.

The new partnership will focus on RNA biology for the discovery and manufacture of new therapies.

AstraZeneca announced a partnership with Pharmacyclics and Janssen for combination trials of MEDI4736 (AstraZeneca) with Imbruvica (Pharmacyclics and Janssen) for the treatment of hematologic cancers.

For cellular therapies to become a viable treatment for large-sized patient groups, steps need to be taken to develop an efficient manufacturing and supply system to minimise the cost of goods.

New research will focus on a superfamily of protein receptors linked to various diseases.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

The new service offering will help customers determine levels of permeability, transport, metabolism, and toxicity in drug product.

Personalized immunotherapy treatments help 90% of acute lymphoblastic leukemia patients achieve remission in a new study.

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.

NIH continues funding for tissue chips to be used in the development of therapeutics.

GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.

The BioPhorum Operations Group has published a resource to help the biopharmaceutical industry deliver a consistent approach to continued process verification.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

Merck KGaA fill-finish expansion in Italy will be completed in 2017.

The Pediatric Clinical Research Group initiative expands to include pediatric research sites.

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.

The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.