Formulation and Drug Delivery, Combination Drugs

AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic

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.

Nemera Receives Drug Manufacturing Authorization for its Autoinjector Facility

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.

Engineered Proteins as Tools in ADC Development and Manufacture

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.

Being Thorough When Transferring Technology

March 01, 2017

BioPharm International

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

The Truth Behind Protein Aggregation in Prefilled Syringes

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.

CMC Biologics Will Manufacture F-star mAb² Bispecific Antibodies

June 07, 2016

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

Scale-Up of Complex Biologics

June 01, 2016

BioPharm International

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

A Review of the Challenges of Delivering Macromolecule Biologicals

April 01, 2016

BioPharm International

Selecting a delivery method early on may be beneficial.

Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity

October 01, 2015

BioPharm International

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

EMA Approves Blincyto, with Conditions

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.