When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

In March 2023, the FDA issued a final guidance, titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products” that describes scientific and regulatory considerations for the development, ...

Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...

USP is developing digital reference standards to integrate into modern digital environments, enhancing regulatory confidence ...

Simtra BioPharma Solutions, a CDMO, formed a five-year strategic alliance with the life science business of Germany-based Merck KGaA, which operates as MilliporeSigma in the U.S. and Canada. The ...

Nurix Therapeutics has had a phase 1 trial of its B-cell malignancy drug put on partial hold by the FDA while the biotech revamps its manufacturing process. The hold follows the company alerting the ...

Figure 1: Examples of Primary Packaging Material Options for Parenteral Drug Products. Primary packaging material (PPM) refers to the material in direct contact with a drug product, serving as the ...

DURHAM, N.C. & CARLSBAD, Calif.--(BUSINESS WIRE)--KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and cGMP contract development and manufacturing organization (CDMO), and Argonaut Manufacturing ...

A company that formulates pharmaceuticals in a sterile environment is spending almost $30 million to expand its headquarters in Lee, Massachusetts.