APIs and Excipients

Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines

June 22, 2018

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

Canada OKs Samsung BioLogics’ mAb Drug Substance Plant

June 21, 2018

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Cambrex Adds R&D Lab for Generic APIs

June 13, 2018

Pharmaceutical Technology's In the Lab eNewsletter

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.

GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory

June 07, 2018

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

AMRI Secures Seven-Year NIH Contract for APIs and Drug Product

June 06, 2018

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

EMA Recommends Four Biosimilars for Approval

June 04, 2018

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

EMA Recommends Approval of Migraine Biologic

June 04, 2018

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

New Tools Outline Advances for Continuous API Processing

June 02, 2018

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

Anti-methamphetamine Antibody Moves to Clinic

June 01, 2018

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Lonza to Manufacture TxCell Product

June 01, 2018

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.