Manufacturing

Feliza Mirasol is the science editor for 

Articles

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.



New FDA Draft Guidance Made Available for Materials Used in Manufacturing CGTs and Tissue-Engineered Therapeutics

SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.

SK pharmteco to Ensure Supply of Ferring Pharmaceuticals Gene Therapy

Charles River has entered into separate agreements with Axovia Therapeutics and Ship of Theseus to offer plasmid DNA manufacturing services for a gene therapy and a lead candidate program, respectively.

Charles River to Provide pDNA Manufacturing Services in Two Deals

With the launch of a new manufacturing service, Memel Biotech will offer services for discovery through to formulation for advance therapy medicinal products.

Memel Biotech to Offer ATMP Manufacturing at Lithuania Site

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

Videos

Can Cellares deliver on the goal to meet total patient demand for cell therapies globally? CEO Fabian Gerlinghaus discusses.

Automation of Clinical Data Key in Meeting Cell and Gene Therapy Demand

Univercells and Altamira Therapeutics are collaborating on nanoparticle-delivered mRNA vaccines, while Andelyn Biosciences and Grace Science are partnering on novel therapies for NGLY1 deficiency.

Univercells and Andelyn Biosciences Form Separate Drug Development Partnerships

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

FDA Greenlights Orchard Therapeutics' Gene Therapy for Children's MLD; AGC Biologics Selected for Manufacturing

Cellares CEO Fabian Gerlinghaus discusses the nuts and bolts of counterflow centrifugal elutriation and electroporation innovations and optimization, while hinting at big news on future release testing of products, as a product itself.

Cellares Cell Shuttle is More Valuable Than the Sum of the Value of the Individual Parts

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen. 

CSL Licenses Cytegrity Lentiviral Vector Production System to Genezen

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods. 

Manufacturing, Gene Therapies