Quality/GMPs

FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.

FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.

BioPharm International® spoke with Sujay Jadhav, CEO of Verana Health about trends in real-world data and the impact these trends will continue to have on the pharmaceutical industry in 2025.

The approval of Hikma Pharmaceuticals’ liraglutide injection marks the first generic version of Victoza, a GLP-1 receptor agonist.

EMA and HMA have published revised guidelines on identification of commercially confidential information and personal data used in marketing authorization applications.

Daniel Giroux, VP of Biologics Development at Abzena, discusses approaches for optimizing process development for the production of proteins.

EMA's committee gave recommendations for marketing authorization of 17 drugs in December, which include therapies for rare heart conditions, anemia, and liver disease.

The European Commission’s approval of the Catalent acquisition by Novo Holdings includes the related acquisition of three manufacturing sites by Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

Many factors must be considered to overcome the challenges associated with viral clearance.

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

A new platform allowing market authorization holders to report drug shortages has gone live.

EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents

As biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.

The agency will review the company’s supplemental new drug application for vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy.

Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.

With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.

With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.

The approval of eladocagene exuparvovec-tneq (Kebilidi) marks the first FDA approval for a gene therapy to treat AADC deficiency.

Eisai Europe and Biogen have received a positive opinion for the monoclonal antibody therapy to be used as a treatment of adult patients with early Alzheimer’s disease.

Chancellor of the Exchequer, Rachel Reeves, has announced a £520 million (US$675 million) investment for manufacturing capacity in the United Kingdom, prompting academic and industry leaders to point out that funds should be used to train personnel.

BioPharm International spoke with Kenneth LaRiviere, head of Engineering at Andelyn Biosciences, about the possible problems that can arise when operating an older facility for biopharmaceutical manufacturing.

The importance of proper analysis of HCPs in the biomanufacturing process was discussed by Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, at AAPS PharmSci 360.

Pfizer’s bivalent RSV prefusion F vaccine has been approved by FDA to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.