Manufacturing

Articles

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

FDA Issues Guidance on CAR-T Cell Product Development

Feliza Mirasol is the science editor for 

Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

Pluri Launches New Cell Therapy CDMO Division

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.

AstraZeneca Poised to Acquire Cell Therapy Developer, Gracell, in Deal Valued at $1.2 Billion

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

Revolutionary therapies restructure pharmaceutical manufacturing.

Leap Year

There are positive indications for future growth.

New Therapies Cry Out for New Skills

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

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

Choosing the Right Excipients for MSC and iPSC Therapies

Through Syena, its oncology-focused product company, Replay will develop and manufacture T-cell receptor and natural killer cell therapies with the NIH and Miltenyi Biotec.

Replay Signs Exclusive Licensing Agreements with NIH and Miltenyi Biotec for Cell Therapy Development and Manufacturing 

Tome Bioscience is facilitating the transition in biology from the editing phase to the cut-and-paste phase.

Tome brings $213 Million to the Programmable Genome Editing Party

Chris Spivey, editorial director for Pharmaceutical Technology, discusses messenger RNA (mRNA) advances with Guillaume Roelandts, Head of Products and Marketing, Quantoom Biosciences, at the 11th International mRNA Health Conference in Berlin, Germany.

Tackling Production Challenges through Greater Access to mRNA Technologies

Novartis and Legend Biotech seek to advance certain CAR-T cell therapy candidates targeting Delta-like ligand protein 3.

Manufacturing, Cell Therapies