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Grand River Aseptic Manufacturing vs Samsung Biologics

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CategoryGrand River Aseptic ManufacturingSamsung Biologics
Listed sitecdmocdmo
SummarySterile 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.Leading CDMO offering end-to-end biologics development and manufacturing from cell line development through aseptic fill-finish, with capabilities in drug substance, drug product, ADC, and mRNA services.
Services
  • 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
  • Cell-Line Development
  • Process Development
  • CMC Analytical Development
  • Technology Transfer
  • CMC Regulatory Submission Support
  • Recombinant Protein Manufacturing
  • Monoclonal Antibody (mAb) Manufacturing
  • ADC (Antibody-Drug Conjugate) Manufacturing
  • mRNA Manufacturing
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Quality Control Testing
  • Biologics Development & Manufacturing
  • Upstream Processing
  • Downstream Processing
  • Vial Filling
  • Stability Testing & Storage
  • Formulation Development
  • Vaccine Manufacturing
  • ADC Payload & Linker Synthesis
  • Lipid Nanoparticle (LNP) Formulation
  • Prefilled Syringe (PFS) Filling
  • Cartridge Filling
  • Lyophilization (Freeze Drying)
Modalities
  • Small Molecule
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Vaccine
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Antibody-Drug Conjugate (ADC)
  • mRNA
  • Vaccine
IndicationsData not yet provided.
  • Oncology
Locations
  • Headquarters, Grand Rapids, Michigan, United States
  • Headquarters
  • Bio Campus I, South Korea
  • Bio Campus II, South Korea
  • Headquarters / Bio Campus I, Incheon, Yeonsu-gu, Republic of Korea
  • Bio Campus II, Incheon, Yeonsu-gu, Republic of Korea
  • ADC Plant, Incheon, Yeonsu-gu, Republic of Korea
  • Samsung Biologics America, United States
  • Samsung Biologics Japan Office, Japan
  • Headquarters
Certifications
  • 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)
Data not yet provided.
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.