Development

Articles

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

Nemera Receives Drug Manufacturing Authorization for its Autoinjector Facility

Adeline Siew is science editor for BioPharm International.

OrlaSURF technology can be used for the development of target-binding assays to monitor the binding of an ADC to its antigen.

Engineered Proteins as Tools in ADC Development and Manufacture

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Communication and taking the time to develop the process are key to successful transfer and scale up of biologics

Being Thorough When Transferring Technology

Interactions between biologic drug products and the components of prefilled syringes can cause protein aggregation, but there are alternative materials that can help mitigate this problem.

The Truth Behind Protein Aggregation in Prefilled Syringes

The collaboration will provide GMP manufacturing ahead of future clinical studies.

CMC Biologics Will Manufacture F-star mAb² Bispecific Antibodies

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

Scale-up of complex, innovative products requires commercialization models that are sustainable.

Scale-Up of Complex Biologics

Selecting a delivery method early on may be beneficial.

A Review of the Challenges of Delivering Macromolecule Biologicals

Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.

Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity

Although the Committee for Medicinal Products for Human Use (CHMP) gave Blincyto a positive opinion, full approval of the drug in the EMA will rely on additional clinical studies.

Formulation and Drug Delivery, Combination Drugs