Manufacturing, Gene Therapies

From scale-up and tech transfer to analytical method development and quality testing, alliances between innovators and contract partners, and between CDMOs and technology vendors, are taking more therapies from lab to patient.

Evozyne’s evolution-based protein design technology will be used to research and develop proteins that could be used in the next generation of gene therapies.

Through the acquisition, Lilly will have access to Prevail’s portfolio of clinical-stage and preclinical neuroscience assets.

Leveraging real-time MRI guidance for intracranial gene therapy administration potentially improves efficacy and outcomes.

The acquisition significantly expands Precision Medicine Group’s cell and gene therapy expertise.

The collaboration will utilize ViGeneron’s novel engineered AAV capsids, vgAAV, to transduce retinal cells with intravitreal injections for an undisclosed target.

Through the acquisition, Eli Lilly will have access to Prevail’s portfolio of clinical-stage and preclinical neuroscience assets.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

The collaboration includes the development, commercialization, and supply of Orgenesis’ pipeline in South Korea and Japan and the development and commercialization of Cure Therapeutics’ pipeline on a global basis.

The gene therapy increases the ability of retina cells to make a soluble form of CD59, a protein that shields the retina from damage, to prevent additional damage and to preserve vision.

Behzad Mahdavi, PhD, will join a team of experts in the company’s Science and Technology Group to fast-track the adoption of new development and drug delivery technologies and manufacturing processes and techniques.

The companies have entered into an agreement for the technology transfer and clinical manufacturing of Mustang’s MB-107 lentiviral gene therapy program for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, in Europe.

The agreement will allow Roche to use CEVEC’s proprietary ELEVECTA technology, which is designed to enable fully scalable, high-performance AAV vector production in suspension bioprocesses.

The HFC Disconnect Series from CPC (Colder Products Company) provides sterile disconnection of tubing used for single-use biopharma and cell and gene therapy manufacturing systems.

A virtual ribbon cutting, tour, and panel discussions were hosted on Oct. 29, 2020 to announce the opening of BioCentriq on the campus of the New Jersey Institute of Technology in Newark, NJ.

Bayer will own the rights to AskBio’s AAV-based gene therapy platform, its intellectual property portfolio, and an established CDMO.

Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.

The new VirusExpress lentiviral production platform increases dose yields and reduces process development time for cell and gene therapies.

Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.

Roche will use Dyno’s CapsidMap platform to develop next-generation adeno-associated virus vectors for gene therapies for central nervous system diseases and liver-directed therapies.

The manufacture of gene therapy vectors is shifting to more modern technologies.

The technology is a novel, plasmid-free manufacturing system for robust and reproducible manufacture of AAV at scale.

Cellnest will join Fujifilm Irvine Scientific’s PRIME-XV portfolio which consists of xeno-free and chemically defined media for stem cell culture.

The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.

The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy.