Biologics APIs

BioNTech and OncoC4 to Co-Develop mAb for Solid Tumor Indications

March 21, 2023

BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.

Sandoz to Build New Biologics Production Facility in Slovenia

March 17, 2023

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Genuv and Celltrion Partner on Development of Novel Therapeutic Antibodies

March 17, 2023

The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.

Influencing Change in Drug Delivery

March 03, 2023

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

Preparing for a New Wave of mRNA Technologies

February 16, 2023

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

SuspendIt Anhydrous Introduced as New Compounding Base

January 11, 2023

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

January 11, 2023

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

Updated REMS Document for Prescription, Biological Drug Product

January 11, 2023

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Managing mRNA Instability During Formulation, Manufacturing, and Shipment

December 03, 2022

Unique solutions are required to protect inherently unstable messenger RNA.

FDA Expands Oversight of Cell and Gene Therapies

October 12, 2022

CBER maps modernization plan to handle surge in research and applications.