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.
Speaking at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, discusses the practical benefits of functional labels in protecting parenteral drugs.
Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
BioPure’s BioClamp connector has been upgraded and is now manufactured to be 13% lighter than the previous model, allowing users to achieve a 26% reduction in carbon dioxide emissions across the full lifecycle of a product.
Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.
Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.
The company said the Stratyx 250 is the first bioreactor of its kind to offer biotech companies a combination of automation, remote process control, and flexibility.
Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.
With up to 88 channels, the CytoFLEX mosaic Spectral Detection Module offers enhanced detection.
Sherwin-Williams will showcase its advanced coating systems, which are designed to ensure safety, sterility, and efficiency in pharmaceutical manufacturing environments.
Winners are selected entirely through industry voting, with those honored representing recognition by their peers.
Having completed its €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has driven the growth of Slovenia’s workforce.
The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.
Sarah Hein, co-founder and CEO of March Biosciences, sat down with BioPharm International® to talk about novel modalities for cancer treatment.
In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.
The £10 million (US$13 million) investment is part of a larger £58 million (US$75 million) Series A financing round to be used for the development of Maxion Therapeutics’ preclinical lead program for treating inflammatory diseases.
The commission’s approval makes durvalumab the first and only immunotherapy for LS-SCLC in the EU.
The addition of the two larger-volume bioreactor sizes to Cytiva’s Xcellerex X-platform portfolio will allow scientists and researchers to scale up from 50 L to 2000 L to meet growing demand for clinical trials and regulatory approved products.
With the investment, AstraZeneca will establish a second global strategic R&D center in Beijing as well as support major research and manufacturing agreements to further advance life sciences in the country.
PharmTech Group chatted with Markus Laubscher of Orbia during DCAT Week 2025, covering the topics of sustainability, regulatory hurdles, next-generation innovation, and the DCAT Week experience.
EsoBiotec’s proprietary lentiviral platform primarily enables the immune system to attack cancers but could ultimately offer patients cell therapy treatments delivered in minutes rather than several weeks.
BioPharm International® spoke with Helen Baker, director of Formulation Design at Quotient Sciences to find out how drug development can be optimized to ensure a more secure supply chain.
Curia plans to expand its sterile fill/finish capabilities at its Glasgow, UK, site and gives updates on an ongoing expansion at its Albuquerque, NM, site.
Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection.
The company is highlighting its commitment to next-generation glass manufacturing in efforts to strengthen the pharmaceutical supply chain.
Christine Mya-San, global account manager at Roquette Pharma Solutions, discusses the most significant pharma ingredients at play over the past year and looks ahead at ingredient innovation.
Russell Miller, vice-president of Global Sales & Marketing at Enzene, discusses how continuous bioprocessing is at the forefront of changing biologics manufacturing moving forward.
PharmTech Group sat down with Anil Kane of Thermo Fisher Scientific live on site at DCAT Week 2025, to talk about technologies and digital solutions companies are using to meet demand across the bio/pharma industry.
PharmTech Group interviewed Lee Karras of Noramco live on site at DCAT Week 2025, shortly after the company announced a $25 million investment in sterile injectable manufacturing capabilities at its Halo Pharma facility in New Jersey.
The company gave a first look at its completed expansion at its manufacturing site in Gliwice, Poland during DCAT Week 2025 in New York City.
