Manufacturing, Gene Therapies

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

CGT Catapult will implement Cellular Origins' robotic platform in its Stevenage, UK, site to establish automated CGT manufacturing.

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.

The separation of deamidated capsids from non-deamidated capsids can be achieved using HIC, according to studies done by a team at Oxford Biomedica.

Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.

ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

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

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.

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

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.

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

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

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

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.

Revolutionary therapies restructure pharmaceutical manufacturing.

There are positive indications for future growth.

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

Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

Collaboration is a key component to achieving long-term success with genetic medicines.

Exagamglogene autotemcel seen as synechdoche.

Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.

Monoclonal antibody and viral vector manufacture share similarities, but vector scale up faces unique challenges.