Manufacturing

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Articles

Three regulatory actions are converging to move biologics, gene therapy, and the ATMP platform forward quickly, say Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, technical, Parexel.

Regulatory Actions Impacting Biologics

In a string of ADC acquisitions, Novartis agreed to acquire Myricx Bio for up to $1.5 billion, gaining an NMTi ADC payload platform designed to overcome resistance in solid tumor treatment.

Why Are Drugmakers Racing to Acquire ADC Payload Platforms?

Dr. Thomas Ybert is chief scientific officer and co-founder of DNA Script and leads the company's research and innovation efforts. Thomas is the main inventor of DNA Script's Enzymatic DNASynthesis (EDS) technology. Holding a PhD in molecular biology and yeast genetics from Ecole Polytechnique, his background includes R&D roles at Sanofi and Total/Amyris.

The future of synthetic biology will depend not only on the ability to design biological systems, but on the capacity to manufacture DNA reliably at scale within regulated frameworks.

Writing the Biological Script: Scaling DNA Manufacturing for the Next Generation of Therapeutics

Kimberly Salgado is Head of Centre for Biosimilar Drug Development, ICON plc

Changes in regulations are reducing costs, expediting approval, and increasing the market for biosimilars.

Faster Doesn’t Mean Easier: Development Impacts of a New Biosimilar Regulatory Landscape

Brian Drapeau is founder, GxPFrame and a cell and gene therapy manufacturing and quality systems consultant.

The cell and gene therapy manufacturing workforce is having to expand on deliverables while remaining under trained.

Training: The Real Constraint in CGT Manufacturing

Feliza Mirasol is the science editor for 

AI and PAT have been shown to reduce manufacturing variability in advanced therapies, which leads to improved process control and accelerated patient access to lifesaving treatments.

Addressing Manufacturing and Access Barriers in Advanced Therapeutics

Lars Hahn is senior vice-president, Global Sales Organization, at Vetter.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

Navigating Biopharma Complexity: Why Long-Term Partnerships Matter 

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

Challenges for the Global Manufacturing of Vaccines

Videos

Jerry Keybl, senior vice-president, Biopharma Products and Strategy, Avantor, discusses innovations in biomanufacturing and recalls his impressions of INTERPHEX 2025 held this past April.

Discussing Pragmatic Solutions to Ground Industry Innovations with Avantor

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

In this exclusive Drug Digest video, Deepak Bahl from Roquette and Jagruti Patel from Lonza look at strategies for accelerating early-stage development while reducing risk, approaches to speeding up timelines for complex formats without sacrificing quality, and maintaining a flexible CMC process that ensures quality.

Manufacturing, Biologic Drugs