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Aldevron vs Fujifilm Pharmaceuticals U.S.A., Inc

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CategoryAldevronFujifilm Pharmaceuticals U.S.A., Inc
Listed sitecdmocdmo
SummaryAldevron is a CDMO specializing in mRNA manufacturing with LNP encapsulation and fill/finish, viral vector production, plasmid DNA, and gene therapy solutions from discovery through commercialization.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
  • mRNA Manufacturing
  • Lipid Nanoparticle (LNP) Formulation
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Process Development
  • CMC Analytical Development
  • Stability Testing & Storage
  • Quality Control Testing
  • Recombinant Protein Manufacturing
  • Cell-Line Development
  • Lentiviral Vector Manufacturing
  • AAV Manufacturing
  • Viral Vector Manufacturing
  • Technology Transfer
  • CMC Regulatory Submission Support
  • Cell Therapy Manufacturing
  • 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
  • mRNA
  • Cell Therapy
  • Gene Therapy
  • Vaccine
  • AAV / Viral Vector Platform
  • mRNA
  • Oligonucleotide
Indications
  • Oncology
  • Metabolic
  • Infectious Disease
  • Rare Disease
  • Oncology
  • Infectious Disease
Locations
  • Breakthrough Campus (Headquarters), Fargo, North Dakota, USA
  • Advance Campus, Fargo, North Dakota, USA
  • Innovate Campus, Madison, Wisconsin, USA
  • Discovery Center, Waltham, Massachusetts, USA
  • Headquarters
Data not yet provided.
Certifications
  • Germany (Competent Authority) · Identifier: Certificate of GMP Compliance of a Manufacturer
  • FDA CBER · Identifier: Pre-License Inspection (PLI) and GMP audit - No Action Indicated (NAI)
  • ISO · Identifier: ISO 13485:2016
Data not yet provided.
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