Hearth

Forge Biologics Selected as an AAV Manufacturing Partner for California Institute for Regenerative Medicine to Help Accelerate Gene Therapy Programs

Retrieved on: 
Wednesday, October 11, 2023
Research, Pharmaceutical, Other Education, Other Manufacturing, Genetics, Education, Clinical Trials, Science, Biotechnology, Manufacturing, Other Science, Health, Regenerative medicine, Patient, CGMP, California Institute for Regenerative Medicine, AAV, CIRM, CDMO, Business development, Pharmaceutical industry, Forge, Hearth

Forge Biologics (Forge), a leading manufacturer of genetic medicines, announced today that it has joined the California Institute for Regenerative Medicine’s (CIRM) Industry Resource Partner Program to help advance the manufacturing of adeno-associated adenovirus (AAV) gene therapy programs from the state of California.

Key Points: 
  • Forge Biologics (Forge), a leading manufacturer of genetic medicines, announced today that it has joined the California Institute for Regenerative Medicine’s (CIRM) Industry Resource Partner Program to help advance the manufacturing of adeno-associated adenovirus (AAV) gene therapy programs from the state of California.
  • Forge joins the CIRM Industry Resource Partner Program and will enable accelerated research and cGMP AAV manufacturing to CIRM-funded programs.
  • As a leader in AAV and plasmid manufacturing, Forge will assist CIRM’s partners—which range from industry to academic investigators—in accelerating gene therapy development and manufacturing.
  • Forge specializes in accelerating AAV gene therapy programs at any stage, from preclinical to clinical and commercial manufacturing.

New Hope Research Foundation and Forge Biologics Announce cGMP Manufacturing Partnership to Accelerate Gene Therapy for Patients with Tay-Sachs Disease

Retrieved on: 
Wednesday, June 28, 2023
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Ignition, Partnership, GM2, Glycogen storage disease, Hope, Multimedia, AAV, Forge, Tay–Sachs disease, CDMO, CGMP, Patient, Entrepreneurship, HEK293, Pharmaceutical industry, Hearth

View the full release here: https://www.businesswire.com/news/home/20230628556153/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230628556153/en/
    “We are proud to be the CDMO partner for New Hope Research Foundation, an organization that is significantly advancing a gene therapy approach to provide hope for patients suffering from Tay-Sachs disease,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics.
  • “At Forge, we are ready to partner with companies, nonprofit organizations, and gene therapy developers around the world, working towards the mission we share to bring potentially life-saving gene therapies to patients.”
    Through this partnership, Forge will provide adeno-associated virus (AAV) process development, analytical services, and cGMP manufacturing to New Hope Research Foundation.
  • The Foundation will leverage Forge’s platform processes, including its proprietary HEK293 suspension Ignition Cells™, to accelerate the initial production.
  • All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio.

Life Biosciences and Forge Biologics Announce cGMP Manufacturing Partnership to Advance Development of Novel Gene Therapies for Aging-Related Diseases

Retrieved on: 
Monday, May 8, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Ignition, Partnership, Ageing, Multimedia, Medicine, AAV, CGMP, Patient, Toxicology, HEK293, Pharmaceutical industry, Hearth, Forge

Life Biosciences (“Life Bio”), a biotechnology company advancing innovative cellular rejuvenation technologies to reverse diseases of aging and injury and ultimately restore health for patients, and Forge Biologics (“Forge”), a genetic medicines manufacturing organization, today announced a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to address aging-related diseases, including its lead program targeting ophthalmic indications.

Key Points: 
  • Life Biosciences (“Life Bio”), a biotechnology company advancing innovative cellular rejuvenation technologies to reverse diseases of aging and injury and ultimately restore health for patients, and Forge Biologics (“Forge”), a genetic medicines manufacturing organization, today announced a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to address aging-related diseases, including its lead program targeting ophthalmic indications.
  • Through this partnership, Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio.
  • All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio.
  • “We are delighted to be working with the Forge team, whose expertise in gene therapy manufacturing is unmatched,” said Jerry McLaughlin, Chief Executive Officer of Life Biosciences.

Forge Biologics and Oculogenex Announce AAV Contract Development and Manufacturing Partnership

Retrieved on: 
Tuesday, January 10, 2023
Health, Genetics, Clinical Trials, Research, Science, Optical, Biotechnology, AAV, Forge, HEK 293, Quality of life, AMD, Partnership, Patient, Retina, Immortalised cell line, Multimedia, Eye, CGMP, Pharmaceutical industry, Vaccine, Hearth

Oculogenex, a biotech company developing a novel adeno-associated viral (AAV) gene therapy treatment to stop the degeneration of central vision in patients, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced a manufacturing partnership to help support the advancement of Oculogenex’s gene therapy program for dry age-related macular degeneration (AMD) toward clinical trials.

Key Points: 
  • Oculogenex, a biotech company developing a novel adeno-associated viral (AAV) gene therapy treatment to stop the degeneration of central vision in patients, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced a manufacturing partnership to help support the advancement of Oculogenex’s gene therapy program for dry age-related macular degeneration (AMD) toward clinical trials.
  • View the full release here: https://www.businesswire.com/news/home/20230110005476/en/
    Forge will provide AAV process and analytical development, and manufacturing services for Oculogenex.
  • The program will utilize Forge’s platform process, including its proprietary HEK 293 suspension Ignition™ cell line and pEMBR™ adenovirus helper plasmid.
  • All AAV development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy cGMP production facility in Columbus, Ohio.

Eikonoklastes Therapeutics and Forge Biologics Announce Viral Vector Contract Development and AAV Manufacturing Partnership

Retrieved on: 
Tuesday, November 29, 2022
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Ignition, Environment, Eikonoklastes, HEK 293, DNA, Multimedia, Therapy, Brain, Partnership, Patient, Movement, CGMP, Motor neuron, Triple-negative breast cancer, Paralysis, Neurodegeneration, ALS, Research, Spinal cord, Clinical trial, AAV, Amyotrophic lateral sclerosis, Forge, Neuron, Pharmaceutical industry, Vaccine, Hearth

View the full release here: https://www.businesswire.com/news/home/20221129005440/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221129005440/en/
    Forge will provide adeno-associated viral (AAV) process development and manufacturing services for ET-101.
  • All development and AAV manufacturing activities will occur at the Hearth, Forges 200,000 square foot gene therapy facility in Columbus, Ohio.
  • Partnering our AAV manufacturing with Forge will further our ability to advance into clinical trials, said Bruce Halpryn, Ph.D., Chair, CEO, and Co-Founder of Eikonoklastes Therapeutics.
  • Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company.

Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients with Krabbe Disease

Retrieved on: 
Tuesday, October 11, 2022
Children, Biotechnology, Manufacturing, Health, Pharmaceutical, Research, Other Manufacturing, Genetics, Consumer, Science, Clinical Trials, CA, HSCT, Congress, ESGCT, CSF, Hope, Diagnosis, Locomotion, Krabbe disease, Lists of diseases, Peripheral nervous system, Cell, CGMP, Patient, Gene, Mesa, Sphingolipid, Dementia, Peripheral neuropathy, Multimedia, White matter, Clinical trial, European Society of Gene and Cell Therapy, Nerve, Psychosine, PNS, Hearing loss, AAV, Cerebrospinal fluid, Degenerative disease, Irritability, GALC, CEO, Hematopoietic stem cell transplantation, Incidence, Death, Safety, Natural history, CNS, M.D, Neurodegeneration, Brain, Plasma, ARM, Infant, Central nervous system, Nervous system, Pharmaceutical industry, Vaccine, Hearth, Krabbe, Forge

Clinical data support preclinical observations that this gene therapy approach after HSCT may lessen many of the immune challenges previously observed with systemic AAV gene delivery and may create a safer environment for gene replacement.

Key Points: 
  • Clinical data support preclinical observations that this gene therapy approach after HSCT may lessen many of the immune challenges previously observed with systemic AAV gene delivery and may create a safer environment for gene replacement.
  • Findings also support this novel approach for extending the delivery of gene replacement strategies to target metabolic diseases amenable to HSCT.
  • Krabbe disease is characterized by mutations in the GALC gene which lead to loss of motor function.
  • RESKUE a Phase 1/2 clinical trial to investigate the safety and efficacy of FBX-101 in patients with Infantile Krabbe disease.

Ray Therapeutics and Forge Biologics Expand Their Viral Vector cGMP Partnership to Encompass Plasmid DNA Manufacturing

Retrieved on: 
Monday, October 10, 2022
Other Manufacturing, Research, Genetics, Clinical Trials, Manufacturing, Biotechnology, Health, Pharmaceutical, Science, Ignition, CA, Retina, Therapy, Retinal ganglion cell, Prevalence, Optogenetics, Retinal degeneration, Field line, Light, CGMP, Person, Biotechnology, Patient, B cell, Research, Program, Multimedia, Â, Severe cognitive impairment, Plasmid, Partnership, Retinitis, Visual acuity, Nyctalopia, Neuron, Ray, AAV, RP, CEO, RGC, DNA, Central retinal artery occlusion, HEK, Retinitis pigmentosa, Pharmaceutical industry, Vaccine, Hearth, Forge

View the full release here: https://www.businesswire.com/news/home/20221010005240/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221010005240/en/
    Forge will provide research-grade and GMP-Pathway plasmid manufacturing services, in addition to adeno-associated viral vector (AAV) process development, scale-up engineering, and cGMP manufacturing services for Ray Therapeutics program, RTx-015.
  • The program will continue to utilize Forges platform manufacturing processes, including its proprietary HEK 293 suspension Ignition Cells and pEMBR adenovirus helper plasmid.
  • All development and cGMP manufacturing activities will occur at the Hearth, Forges 200,000 square foot gene therapy cGMP production facility in Columbus, Ohio.
  • Ray Therapeutics lead candidate RTx-015 uses intravitreal administration, from which the vector diffuses into the retina and transduces primarily the RGCs.

Myrtelle and Forge Biologics Announce Viral Vector and Plasmid DNA cGMP Manufacturing Partnership

Retrieved on: 
Monday, October 3, 2022
Health, Biometrics, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Ignition, CNS, Forge, GMP, Technology, AAV, CEO, Multimedia, Inc., CGMP, RHI, Pfizer, Ear, Partnership, Rita Raave, Program, Patient, Hearing, Neurodegeneration, Intellectual property, HEK 293, Pharmaceutical industry, Vaccine, TMPRSS3, Hearth, Myrtelle Canavan

View the full release here: https://www.businesswire.com/news/home/20221003005359/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221003005359/en/
    Forge will provide research-grade and GMP-Pathway plasmid manufacturing services as well as cGMP adeno-associated viral (AAV) process development and scale-up manufacturing services for Myrtelles program, Myr-201.
  • The program will utilize Forges platform process including its proprietary HEK 293 suspension Ignition Cells and pEMBR adenovirus helper plasmid.
  • All development and cGMP manufacturing activities will occur at the Hearth, Forges 200,000 square foot gene therapy cGMP facility in Columbus, Ohio.
  • The Hearth is a custom-designed cGMP facility focused on AAV manufacturing and can host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.

Forge Biologics to Present and Participate at Upcoming Investor Conferences

Retrieved on: 
Thursday, September 29, 2022
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Forge, CGMP, AAV, Hearth

Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company.

Key Points: 
  • Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company.
  • Forges mission is to enable access to life changing gene therapies and help bring them from idea to reality.
  • Forges 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters.
  • By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

Forge Biologics Fuels Gene Therapy Manufacturing Engine with Launch of Plasmid DNA Manufacturing Services to Support AAV Clients

Retrieved on: 
Tuesday, September 27, 2022
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, OH, AAV, Exhibition, CGMP, Bioreactor, Plasmid, Company, Patient, Research, DNA, Conference, GMP, Vaccine, Pharmaceutical industry, Hearth, Forge

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced the new availability of plasmid DNA manufacturing to its suite of scalable manufacturing services for gene therapy programs, complementing Forges existing AAV process development, analytical development, cGMP manufacturing, and automated final fill capabilities.

Key Points: 
  • Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced the new availability of plasmid DNA manufacturing to its suite of scalable manufacturing services for gene therapy programs, complementing Forges existing AAV process development, analytical development, cGMP manufacturing, and automated final fill capabilities.
  • Forges plasmid production services utilize single-use systems that seamlessly integrate into the Companys platform AAV manufacturing process, allowing continuity of manufacturing for clients and streamlined vendor management.
  • All plasmid production will occur at Forges manufacturing facility, the Hearth, in Columbus, OH, and is available exclusively to clients performing their AAV manufacturing at Forge.
  • The Hearth is a custom-designed cGMP facility focused on AAV manufacturing and can host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.