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Forge Biologics vs Fujifilm Pharmaceuticals U.S.A., Inc

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CategoryForge BiologicsFujifilm Pharmaceuticals U.S.A., Inc
Listed sitecdmocdmo
SummaryDedicated AAV gene therapy CDMO with a 200,000+ sq. ft. cGMP facility featuring 20 suites and bioreactors up to 5,000L, supporting 60+ clients across 35+ indications with high-yield manufacturing and seamless regulatory compliance.CDMO specializing in liposome and lipid nanoparticle (LNP) formulation development and GMP manufacturing from bench to commercial scale, with mRNA process development and aseptic fill-finish capabilities.
Services
  • AAV Manufacturing
  • Viral Vector Manufacturing
  • Upstream Processing
  • Downstream Processing
  • CMC Analytical Development
  • Process Development
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Vial Filling
  • Stability Testing & Storage
  • Quality Control Testing
  • CMC Regulatory Submission Support
  • Technology Transfer
  • Formulation Development
  • Process Development
  • Lipid Nanoparticle (LNP) Formulation
  • mRNA Manufacturing
  • Upstream Processing
  • Downstream Processing
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Quality Control Testing
  • Technology Transfer
Modalities
  • Gene Therapy
  • AAV / Viral Vector Platform
  • mRNA
  • Oligonucleotide
Indications
  • Rare Disease
  • Neurology
  • Ophthalmology
  • Immunology
  • Infectious Disease
  • Cardiovascular
  • Metabolic
  • Respiratory
  • Dermatology
  • Gastroenterology
  • Nephrology
  • Women's Health
  • Psychiatry
  • Oncology
  • Oncology
  • Infectious Disease
Locations
  • Headquarters & Manufacturing (The Hearth), Grove City, Ohio, United States
  • Headquarters & Manufacturing, Grove City, Ohio, United States
  • The Hearth (Manufacturing Facility)
  • The Hearth (Manufacturing Facility), United States
Data not yet provided.
Certifications
  • EU GMP · Identifier: EU GMP Compliant
  • FDA · Identifier: cGMP Compliant
  • EMA · Identifier: EU GMP
  • FDA · Identifier: cGMP
  • EMA · Identifier: cGMP
Data not yet provided.
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.