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Argonaut Manufacturing Services vs Grand River Aseptic Manufacturing

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CategoryArgonaut Manufacturing ServicesGrand River Aseptic Manufacturing
Listed sitecdmocdmo
SummaryArgonaut is a sterile fill-finish CDMO specializing in isolator-based aseptic manufacturing for biologics, peptides, nucleic acids, lipid nanoparticles, gene therapies, and vaccines from preclinical through commercial scale, with FDA and Annex 1 compliance.Sterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines.
Services
  • Vial Filling
  • Prefilled Syringe (PFS) Filling
  • Cartridge Filling
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Quality Control Testing
  • CMC Analytical Development
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Vial Filling
  • Prefilled Syringe (PFS) Filling
  • Cartridge Filling
  • Lyophilization (Freeze Drying)
  • Quality Control Testing
  • Secondary Packaging & Labeling
  • Serialization & Track-and-Trace
  • Stability Testing & Storage
  • CMC Analytical Development
  • Technology Transfer
  • CMC Regulatory Submission Support
  • Controlled Substance Manufacturing
  • Vaccine Manufacturing
  • Monoclonal Antibody (mAb) Manufacturing
  • Biologics Development & Manufacturing
  • API Synthesis & Manufacturing
  • Small Molecule Development & Manufacturing
Modalities
  • Biologics (Other)
  • Peptide
  • Oligonucleotide
  • Gene Therapy
  • Vaccine
  • Small Molecule
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Vaccine
IndicationsData not yet provided.Data not yet provided.
Locations
  • Headquarters, Carlsbad, CA, USA
  • Headquarters, Grand Rapids, Michigan, United States
  • Headquarters
Certifications
  • FDA · Identifier: 21 CFR 210, 211, 820
  • EMA · Identifier: Annex 1
  • GMP · Identifier: Five GMP manufacturing facilities
  • Annex 1 · Identifier: Three facilities designed and qualified with Annex 1 revisions
  • GMP · Identifier: Five GMP manufacturing facilities; three Annex 1 compliant
  • FDA · Identifier: GMP
  • EMA · Identifier: Annex 1
  • GMP · Identifier: Five GMP manufacturing facilities (three Annex 1 compliant)
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.