Manufacturing

Videos

In part 2 of this 2-part interview, Jason Bock, founder and CEO of CTMC provides input on how the FDA's proposed manufacturing registration rule may impact personalized therapies.

FDA's Manufacturing Registration Rule's Impact on Advanced Therapies: Part 2

Jason Bock, founder and CEO of CTMC, provides his perspective on the FDA’s proposed rule to streamline registration for single distributed manufacturing establishments, and what the change may mean for personalized medicines.


FDA's Manufacturing Registration Rule's Impact on Advanced Therapies: Part 1

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

It is essential to understand how raw material variability can create challenges in process control for autologous adoptive cell therapies. 

Overcoming Raw Material Variability Challenges for Autologous Adoptive Cell Therapies 

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

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The new partnership will work to embed digital identification into labware, solving chain-of-identity challenges for individualized cell and gene therapies.

Say Cheese: Avantor, p-Chip Bring COI Compliance to Clinical Consumables

 is senior vice-president and general manager (IDMO Business), Cellares.

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the bio/pharmaceutical trends from 2024 that continue to impact the industry in 2025.

Industry Outlook 2025: Cell Therapy Advancement

The move towards “pharma 4.0” requires a major shift, both ideologically and technologically, to adapt current processes to a framework that will automate much of today’s manufacturing.

Pharma 4.0: What are Industry Leaders Prioritizing in the Modernization of Pharmaceutical Manufacturing? 

With a completed €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 led to the growth of Slovenia’s workforce.

Novartis’ Steady Investments in Slovenia Result in New Viral Vector Manufacturing Facility and a Growing Work Force

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Brian Feth, Xcell Biosciences; Thomas Heathman, Ori Biotech; and Matthew Lauber, Waters Corporation go behind the headlines and discuss commercialization challenges in the cell and gene therapy space; advances in new genomics tools from Roche, Illumina, and Eikon; and the latest development and manufacturing partnerships. 

Manufacturing, Cell Therapies