
Executive Director Emer Cooke presents EMA’s achievements for the year.
Susan Haigney is lead editor of BioPharm International®.

Executive Director Emer Cooke presents EMA’s achievements for the year.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets.

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.

Co-legislators in Europe have reached a provisional agreement on a new pharmaceutical policy framework to help boost competitiveness, innovation, and supply chain security.

A new facility in Tennessee will boost high-speed pharma packaging capacity and strengthen US supply chain support.

The new Tethered Cap, which will be showcased at 2026 Pharmapack Europe, addresses the demand for sustainability with a TE safety ring that remains attached to the cap.

David Basile, VP Technical Operations, Americas, Hovione, explains what regulators expect for the maintenance of GMP facilities and equipment.

Luca Cavazzini, Sales & Marketing Director at IMA Active, discusses some of the industry’s most common manufacturing challenges, such as sustainability, continuous processes, and technology advancements.

FDA has granted orphan drug designation to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis.

Starting with risk mitigation, GMP facility and equipment maintenance is all about anticipating problems before they happen and showing regulators a controlled environment.

The agency is expanding its use of artificial intelligence (AI) with the deployment of agentic AI for staff to create more complex AI workflows and harness AI models.

The first patient visit has taken place for the SURMOUNT-REAL UK clinical trial of Eli Lilly and Company’s weight-loss drug, tirzepatide.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle regulatory inspections and client expectations.

In a poster presentation at AAPS PharmSci 360, Eda Fenercioglu, a scientist at Pfizer, outlines a streamline workflow for identifying and mitigating visible particles in biologic drugs.

Pharmaceutical Technology® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss some of the unique instruments used to conduct bioanalysis.

Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen, provides a look into some of the trends impacting bioanalysis in biopharmaceutical development and manufacturing.

Pharmaceutical Technology® spoke with Dr. Mark Arnold, owner and principal, Bioanalytical Solution Integration, ahead of AAPS PharmSci 360 to find out how bioanalysis enhances bio/pharmaceutical drug development.

Pharmaceutical Technology® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss how LC–MS is used in bioanalysis.

Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen, explains how artificial intelligence, machine learning, and large language models are used in performing bioanalysis.

Vishal Mukund Sonje, Vaccine Manufacturing Lead, CEPI, talks about the challenges that arise in the manufacturing of vaccines in various global regions.

Pharma companies are focusing on sustainability efforts to meet client expectations, environmental audits, and climate pressures.

Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company, discusses what makes a CDMO that offers end-to-end service beneficial.

Pharmaceutical Technology® spoke with Peter Freed, head of Global Pharma CTS, Roquette, about a variety of materials-related topics including protein stability, tablet coating, sustainability, and securing the supply chain.

ACG showcased the expansion of its European presence, and Bora Pharmaceuticals participates in a discussion about CDMO innovation.

Pharmaceutical Technology® spoke with Dr. Weite Oldenziel, CEO of Ofichem, before CPHI Frankfurt 2025 to get his perspective on the API market and why it is important to qualify API suppliers.

Pharmaceutical Technology® spoke with Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences Company, ahead of CPHI Frankfurt 2025 to find out what makes an end-to-end service provider beneficial to sponsor companies and how digital technologies are changing the industry.

Radiopharmaceuticals are allowing for the targeted treatment of cancers, but they do pose challenges.

Vishal Mukund Sonje, Vaccine Manufacturing Lead, CEPI, talks about the challenges that arise in the manufacturing of vaccines in various global regions and gives a preview of his presentation at CPHI Frankfurt 2025.

Pharmaceutical packaging plays an important role in sustainability efforts. Maija Pohjakallio, VP, Climate and Circular Economy, Metsä Group, explains how fiber-based packaging can help with these efforts.

Pharmaceutical Technology® spoke with Tara Dougal, Event Director for Pharma at Informa Markets about what attendees at CPHI Frankfurt should expect this year.

Published: January 10th 2025 | Updated: January 13th 2025

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