The Hearth

Ray Therapeutics and Forge Biologics Announce Viral Vector Contract Development and cGMP Manufacturing Partnership

Retrieved on: 
Tuesday, March 1, 2022
Other Manufacturing, Research, Genetics, Clinical Trials, Manufacturing, Biotechnology, Health, Pharmaceutical, Science, Eye, The Hearth, Partnership, Optogenetics, Retinitis pigmentosa, RP, Ray, Nyctalopia, Prevalence, Retina, AAV, Ophthalmology, Therapy, CA, Neuron, Person, Central retinal artery occlusion, Multimedia, Biotechnology, Visual acuity, Retinal degeneration, Severe cognitive impairment, Patient, B cell, HEK 293, Light, Program, Field line, CGMP, Retinal ganglion cell, CEO, RGC, Medical imaging, Pharmaceutical industry, Forge, Hearth

View the full release here: https://www.businesswire.com/news/home/20220301005482/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220301005482/en/
    Forge will provide adeno-associated viral (AAV) process development, scale-up engineering and cGMP manufacturing services for Ray Therapeutics program, Ray-001.
  • All development and cGMP manufacturing activities will occur at The Hearth, Forges 200,000 ft2 gene therapy cGMP production facility in Columbus, Ohio.
  • We look forward to helping Ray Therapeutics advance their AAV manufacturing with an eye towards restoring vision in patients with ophthalmology disorders.
  • Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company.

Solid Biosciences and Forge Biologics Announce Viral Vector Contract Development and cGMP Manufacturing Partnership

Retrieved on: 
Monday, October 4, 2021
Other Manufacturing, Research, Genetics, Stem Cells, Manufacturing, Biotechnology, Pharmaceutical, Health, Science, Other Science, Ignition, Duchenne muscular dystrophy, Partnership, The Hearth, Security (finance), CDMO, Therapy, CGMP, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, FDA, Multimedia, Patient, Program, Family, Disease, DMD, IGNITE, IND, Safety, AAV, Nasdaq, Mutation, HEK293, Pharmaceutical industry, Forge Biologics, Solid Biosciences, FORGE BIOLOGICS, SOLID BIOSCIENCES

Solid Biosciences Inc. (Solid, Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), and Forge Biologics, a cell and gene therapy-focused contract development and manufacturing organization (CDMO), announced a partnership to advance the development and manufacturing of SGT-003, Solids next generation gene therapy program for Duchenne.

Key Points: 
  • Solid Biosciences Inc. (Solid, Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), and Forge Biologics, a cell and gene therapy-focused contract development and manufacturing organization (CDMO), announced a partnership to advance the development and manufacturing of SGT-003, Solids next generation gene therapy program for Duchenne.
  • View the full release here: https://www.businesswire.com/news/home/20211004005324/en/
    Forge will provide an adeno-associated viral (AAV) vector process, scale-up engineering and cGMP manufacturing services for SGT-003.
  • All development and cGMP manufacturing activities will occur at The Hearth, Forges 175,000 ft2 gene therapy cGMP production facility in Columbus, Ohio.
  • Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company.

Forge Biologics Announces Regulatory Updates from FDA and EMA, Accelerating Manufacturing and Clinical Trial Momentum

Retrieved on: 
Monday, September 20, 2021
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Ignition, COMP, Muscle weakness, Hearing loss, The Hearth, Peripheral neuropathy, Therapy, European Medicines Agency, CGMP, FDA, Psychosine, Multimedia, Patient, Regulatory affairs, Hematopoietic stem cell transplantation, Irritability, Quality, Death, GALC, European Union, Krabbe disease, Disease, Technology, HEK293, Peripheral nervous system, Union, Research, Brain, Cell, AAV, Lipid, EMA, Galactosylceramidase, Pharmaceutical industry, Vaccine, Krabbe Disease, FBX-101, Orphan Designation, Forge Biologics, KRABBE DISEASE, FBX-101, ORPHAN DESIGNATION, FORGE BIOLOGICS

FBX-101 previously received Orphan Drug and Rare Pediatric Disease Designations from the FDA earlier this year.

Key Points: 
  • FBX-101 previously received Orphan Drug and Rare Pediatric Disease Designations from the FDA earlier this year.
  • Forge presented information to the FDA on its proprietary HEK293 suspension cell line, Ignition Cells, and adenovirus helper plasmid, pEMBR, and received FDA alignment that these technologies are suitable for cGMP manufacturing of clinical drug products.
  • The Hearth is a custom-designed cGMP facility dedicated to AAV vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.
  • By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.