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Grand River Aseptic Manufacturing vs Halix

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CategoryGrand River Aseptic ManufacturingHalix
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.HALIX is a mammalian expression CDMO specializing in viral vectors, viral vector vaccines, and recombinant proteins from development through GMP manufacturing and fill-finish at clinical and commercial scale.
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
  • Upstream Processing
  • Downstream Processing
  • Recombinant Protein Manufacturing
  • Monoclonal Antibody (mAb) Manufacturing
  • Viral Vector Manufacturing
  • Vaccine Manufacturing
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Lyophilization (Freeze Drying)
  • Vial Filling
  • Quality Control Testing
  • Process Development
  • Technology Transfer
  • CMC Regulatory Submission Support
  • Secondary Packaging & Labeling
Modalities
  • Small Molecule
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Vaccine
  • Vaccine
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
IndicationsData not yet provided.
  • Oncology
  • Infectious Disease
  • Respiratory
Locations
  • Headquarters, Grand Rapids, Michigan, United States
  • Headquarters
  • Headquarters & Manufacturing, Leiden, South Holland, Netherlands
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)
  • EMA · Identifier: EU GMP Grade C and Grade B
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.