Quality Systems

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.

The European Union is discussing ways to reduce Europe’s over-reliance on imports of APIs.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Aviva Capital Partners and developer Socius are investing £1 billion to develop a cancer research and treatment center in Sutton, London.

The pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about how the political landscape may impact the pharmaceutical industry.

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

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 EMA’s revised guidelines on data protection in marketing authorization applications.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the impact of the changing political landscape on the pharmaceutical industry.

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the impact of the post-COVID-19 world on the pharmaceutical industry and how that has shifted the talent pool.

SkyCell is working with Microsoft to incorporate SkyCell’s AI-powered supply chain solution into Microsoft Teams and Copilot.

Advancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

Advanced solutions are improving drug dissolution, absorption, and overall therapeutic performance.

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Michael Franco, global sales director at PSG Biotech, spoke with the PharmTech Group at INTERPHEX 2025 about recent advancements in pharmaceutical flow sensor technology.

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.