Formulation and Drug Delivery, Combination Drugs

November 10, 2017

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.

September 28, 2017

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.

April 01, 2017

BioPharm International

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

March 01, 2017

BioPharm International

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

November 01, 2016

BioPharm International

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.

June 07, 2016

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

June 01, 2016

BioPharm International

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

April 01, 2016

BioPharm International

Selecting a delivery method early on may be beneficial.

October 01, 2015

BioPharm International

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

September 28, 2015

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.