Quality Systems

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.

Pharmaceutical Technology® spoke with Krishna Kanumuri, CEO of Sai Life Sciences, about which trends from 2024 will carry over and impact the bio/pharma industry in 2025.

Josh Hoerner, general manager of Purisys, provides his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.

New TCR-T cell therapies look promising in the treatment of haematological and solid tumours.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

The Act is the European Union’s plan to avert drug shortages.

Christian Cobaugh, Eswar Iyer, and Vincenzo Antignani go behind the headlines to discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old.

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

The Omni ASCENT, officially launched at INTERPHEX 2025, is a next-generation off-site manufactured vertical utility solution aimed at optimizing the flexibility and efficiency of cleanrooms.

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about how the geopolitical instabilities might impact the bio/pharmaceutical industry.

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about which trends from 2024 he expects to impact the bio/pharmaceutical industry in 2025.

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about the impact of artificial intelligence and machine learning on the bio/pharmaceutical industry.

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.