Biologics APIs

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.

Biologic Standards in the Pharmacopoeias: An Update

October 02, 2022

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

Synthego Aims to Accelerate Drug Discovery with New Engineered Cell Libraries

August 04, 2022

Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.

Progress in the Development of CAR NK-Cell Therapies

August 03, 2022

Further advances in construct design and manufacturing scalability are still needed.

Novasep-PharmaZell Invests €7.3M to Increase API Production Capacity

August 02, 2022

Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.

VeriSIM Life and Mayo Clinic Team Up to Co-develop New Therapies

July 08, 2022

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.