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Catalent vs Grand River Aseptic Manufacturing

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CategoryCatalentGrand River Aseptic Manufacturing
Listed sitecdmocdmo
SummaryGlobal CDMO providing end-to-end contract development and manufacturing for pharma, biotech, and consumer health. Delivers 60+ billion doses annually across small molecules, biologics, cell & gene therapies, and clinical supply.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
  • Cell Therapy Manufacturing
  • Viral Vector Manufacturing
  • AAV Manufacturing
  • Oral Solid Dosage Manufacturing
  • Inhalation & Nasal Dosage Manufacturing
  • Formulation Development
  • Process Development
  • CMC Analytical Development
  • Technology Transfer
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Quality Control Testing
  • Recombinant Protein Manufacturing
  • Biologics Development & Manufacturing
  • API Synthesis & Manufacturing
  • Small Molecule Development & Manufacturing
  • Monoclonal Antibody (mAb) Manufacturing
  • Secondary Packaging & Labeling
  • Stability Testing & Storage
  • CMC Regulatory Submission Support
  • Allogeneic Cell Therapy Manufacturing
  • Autologous Cell Therapy Manufacturing
  • Cell-Line Development
  • Upstream Processing
  • Downstream Processing
  • Vial Filling
  • Prefilled Syringe (PFS) Filling
  • Topical & Semi-Solid Manufacturing
  • Serialization & Track-and-Trace
  • Cold-Chain Storage & Logistics
  • Cartridge Filling
  • Lyophilization (Freeze Drying)
  • Lentiviral Vector Manufacturing
  • 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
  • Small Molecule
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Cell Therapy
  • Gene Therapy
  • AAV / Viral Vector Platform
  • Small Molecule
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Vaccine
IndicationsData not yet provided.Data not yet provided.
Locations
  • Headquarters, United States
  • Asia Pacific, Asia Pacific
  • Europe, Europe
  • Latin America, Latin America
  • North America, North America, United States
  • China, China
  • Japan, Japan
  • North America, North America
  • Headquarters / Global Operations
  • Cell Therapy Center of Excellence, Princeton, New Jersey, United States
  • Soft Chew Manufacturing, Manassas, Virginia, United States
  • Global Network
  • Headquarters, Grand Rapids, Michigan, United States
  • Headquarters
Certifications
  • GMP · Identifier: Nine GMP facilities
  • FDA · Identifier: 21 CFR 111
  • FDA · Identifier: 21 CFR 117
  • 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.