Gene Therapy Production Articles & Analysis
33 news found
The proceeds will enable ViGeneron to accelerate its proprietary viral vector-based gene therapy platforms and drive product development in its two lead ophthalmic gene therapy programs. ...
In this webinar, I look forward to exploring current and new strategies for optimising the upstream AAV vector production process, a vital first step towards advancing gene therapies to meet clinical and commercial ...
PT, in Carlsbad, CA Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today that Chief Medical Officer Maria Escolar, M.D, MS., will present updated clinical data from the RESKUE Phase 1/2 clinical trial for FBX-101—the Company’s novel gene therapy for the ...
Ray Therapeutics, a biotechnology company developing optogenetic gene therapies for patients with retinal degenerative conditions, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced further collaboration for their manufacturing partnership to include clinical stage plasmid ...
Waisman’s expert team will be working closely with BriaCell’s scientific and product development teams to ensure timely production of Bria-Pros™ in compliance with applicable regulatory requirements by the FDA. ...
ASC Therapeutics has joined forces with Charles River to scale the manufacturing of ASC618, its second-generation virus-based gene therapy for hemophilia A. The agreement expands upon their current collaboration, begun in 2019 that focused on achieving Good Manufacturing Practice (GMP)-virus manufacturing and establishing processes for adeno-associated virus ...
This will allow our teams to work efficiently together during the development phase and through the manufacturing process.” Cell Therapies CEO, Mr Peter Giannopoulos, said: “As the first Australian site to obtain TGA approval to commence onshore manufacture of CAR-T cell therapy products, we are delighted to now be working with an ...
About RP-L201 RP-L201 is an investigational gene therapy product being developed for severe Leukocyte Adhesion Deficiency-I (LAD-I). The therapy consists of hematopoietic stem cells from the patient that have been genetically modified with a lentiviral vector to contain a functional copy of the ITGB2 gene. ...
(Nasdaq: AVRO), a leading clinical-stage gene therapy company with a shared purpose to free people from a lifetime of genetic disease, today reported new interim data, including on new visual motor integration, motor coordination and visual perception measures, from a collaborator-sponsored, ongoing Phase 1/2 gene therapy ...
(Matica Bio), a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, today announced the opening of its new 45,000-square-foot facility dedicated to the production of viral vectors and cell-based products used in cell and ...
Pronalyse is a new division of Creative Proteomics, which is an integrated CRO company with rich experience in providing drug development services. The product manager of the company is excited to launch the Gene Therapy Products Characterization service to help clients overcome the challenges of gene ...
Regeneron receives access to ViGeneron’s vgAAV capsids for one inherited retinal disease target and an option for an exclusive license to develop and commercialize the gene therapy product ViGeneron is eligible to receive upfront payment, research funding, option exercise fee, development and commercial milestone payments, plus royalties ...
Within the facility, the space dedicated for cell and gene therapy will offer integrated CDMO services for mRNA, viral vectors, and plasmid DNA, providing GMP production with multiple segregated cleanrooms to deliver greater manufacturing efficiency. ...
-GI Innovation·GI Cell, respectively establishing a cell therapy center at Severance Hospital·Songdo Severance Hospital(tentative named) -Establishment of the seamless process for research, production, clinical trials, Regulatory affair (RA), and etc. of advanced biopharmaceutical GI Innovation, a new innovative drug development company, announced ...
(Nasdaq: SGMO), a genomic medicine company, today announced updated preliminary results from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. These latest data show that, as of the November 9, 2021 cutoff date, the investigational ...
Virica Biotech Inc., a leading developer of solutions for scaling of viral medicines, today announced it will collaborate with Oxford BioMedica plc (LSE:OXB), a leading gene and cell therapy company, to improve the yield and production efficiency of Oxford Biomedica’s next generation lentiviral vector gene ...
Banik’s extensive experience in process development and clinical manufacturing of stem cell products has been key to the development of Neurona’s manufacturing processes and production of NRTX-1001 clinical lots in the company’s own cGMP facility. ...
Gene therapy candidate has potential to address a large number of retinitis pigmentosa and Leber congenital amaurosis gene mutations with a single product Trial to start in Q1 2022 will enroll patients with mutations in NR2E3 or RHO genes MALVERN, Pa., Dec. 09, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. ...
(Nasdaq: SGMO), a genomic medicine company, today announced preliminary results from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. As of the September 17, 2021 cutoff date, results from the four patients treated in the first two ...
At CPhI Worldwide 2021, Thermo Fisher Scientific will showcase its newest capabilities across its global pharma services network which help pharmaceutical and emerging biotech companies accelerate time to market in a wide range of modalities and platforms including cell and gene therapies, drug products and biologics. CPhI 2021 begins with a ...