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Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.

Manufacturing sites and a control site will work together in a hub-and-spoke model that has key differences from conventional manufacturing operations.

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

The investment is part of CGT Catapult’s Cross-Catapult Investment Pilot and will accelerate the pre-clinical development of Spliceor’s trans-splicing gene therapy platform.

Three deaths attributed to acute liver failure appear to have occurred following regular treatment or investigational therapy.

Minimize contamination in cell therapy manufacturing with isolators, staff protocols, sterile materials, and validated suppliers for process integrity.

The company’s gene therapy, AAVB-039, for the treatment of Stargardt disease progresses to a Phase I/II clinical trial.

Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.

Northway Biotech will develop and scale production of AATec’s ATL-105 for the treatment of non-CF bronchiectasis.

Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

The consortium will focus on the delivery of a fully automated robotics cell and gene therapy manufacturing platform.

Stoboclo and Osenvelt (both denosumab-bmwo) reference Amgen’s Prolia and Xgeva, respectively.

Increased capacity will help Circio progress development of circVec AAV gene therapy and in-vivo cell therapy, with the company setting a goal of selecting its first therapeutic candidate in 2026.

Biocon said that, according to clinical data, both Vevzuo and Evfraxy demonstrated a safety and efficacy profile comparable to that of the reference product.

As development of novel drugs accelerates, enhanced downstream production processes maintain product efficacy, safety, and quality.

Linvoseltamab-gcpt, marketed as Lynozyfic, is a bispecific antibody designed to facilitate T cell activation and cancer cell killing.

The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.

The new building will create 150 new jobs and expands total production area to nearly 12,000 square meters.

Using its proprietary Optimer delivery vehicle, the company said it uncovered a previously unexploited protein marker expressed on activated hepatic stellate cells.

In contrast to earlier conferences in 2025, experts interviewed as part of the BIO conference in Boston did not come to a consensus about lasting impacts of recent changes in US government policy.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

In this episode of the Ask the Expert video series, Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma, discusses the options available for controlling adventitious contamination in cell processing and the use of closed processing systems for cell therapy production.

EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.

In preclinical trials in mice, the vaccine delivery system provided protection against malaria that was strong enough to stand up to the efficacy of traditional multi-dose regimens.