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Aldevron vs Biomay AG

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CategoryAldevronBiomay AG
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.GMP CDMO specializing in plasmid DNA, mRNA, and recombinant protein manufacturing from gene construction to market supply, with in-house mRNA lipid-nanoparticle formulation 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
  • mRNA Manufacturing
  • Cell-Line Development
  • Recombinant Protein Manufacturing
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Lipid Nanoparticle (LNP) Formulation
  • Process Development
  • CMC Analytical Development
  • CMC Regulatory Submission Support
Modalities
  • mRNA
  • Cell Therapy
  • Gene Therapy
  • Vaccine
  • AAV / Viral Vector Platform
  • mRNA
  • Gene Therapy
Indications
  • Oncology
  • Metabolic
  • Infectious Disease
  • Rare Disease
Data not yet provided.
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
  • Headquarters, Vienna, Austria
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
  • EMA · Identifier: GMP
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.