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Boston Institute of Biotechnology, LLC vs Halix

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CategoryBoston Institute of Biotechnology, LLCHalix
Listed sitecdmocdmo
SummaryFull-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy manufacturing from preclinical to commercial scale, with bioreactor capacity up to 50,000L.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
  • Cell-Line Development
  • Process Development
  • CMC Analytical Development
  • Formulation Development
  • Stability Testing & Storage
  • Quality Control Testing
  • Upstream Processing
  • Downstream Processing
  • Recombinant Protein Manufacturing
  • Monoclonal Antibody (mAb) Manufacturing
  • Microbial Fermentation
  • Vaccine Manufacturing
  • AAV Manufacturing
  • Viral Vector Manufacturing
  • Vial Filling
  • Lyophilization (Freeze Drying)
  • Prefilled Syringe (PFS) Filling
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Technology Transfer
  • CMC Regulatory Submission Support
  • Analytical Method Development & Validation
  • ICH Stability Studies
  • 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
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Gene Therapy
  • Cell Therapy
  • Peptide
  • AAV / Viral Vector Platform
  • Vaccine
  • Vaccine
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
IndicationsData not yet provided.
  • Oncology
  • Infectious Disease
  • Respiratory
Locations
  • Southborough, Southborough, Massachusetts, United States
  • Zhangjiang (P01), Shanghai, Shanghai, China
  • Lingang (IP02), Shanghai, Shanghai, China
  • Lingang (IP03), Shanghai, Shanghai, China
  • Headquarters, Southborough, Massachusetts, United States
  • Headquarters & Manufacturing, Leiden, South Holland, Netherlands
CertificationsData not yet provided.
  • 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.