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Charles River Cell & Gene Therapy vs KBI Biopharma, Inc.

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CategoryCharles River Cell & Gene TherapyKBI Biopharma, Inc.
Listed sitecdmocdmo
SummaryCharles River provides discovery, development, and manufacturing services across the drug development continuum, including cell and gene therapy capabilities.Global CDMO offering cell line development, process development, analytical services, and cGMP clinical and commercial manufacturing for biologics including monoclonal antibodies and recombinant proteins.
Services
  • CMC Regulatory Submission Support
  • Quality Control Testing
  • Technology Transfer
  • Formulation Development
  • Process Development
  • Cell Therapy Manufacturing
  • Viral Vector Manufacturing
  • Recombinant Protein Manufacturing
  • Monoclonal Antibody (mAb) Manufacturing
  • Biologics Development & Manufacturing
  • API Synthesis & Manufacturing
  • Upstream Processing
  • Downstream Processing
  • CMC Analytical Development
  • Stability Testing & Storage
  • Cell-Line Development
  • Microbial Fermentation
  • Small Molecule Development & Manufacturing
  • AAV Manufacturing
  • Lentiviral Vector Manufacturing
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Cell-Line Development
  • Process Development
  • CMC Analytical Development
  • Formulation Development
  • Recombinant Protein Manufacturing
  • Microbial Fermentation
  • Upstream Processing
  • Downstream Processing
  • Quality Control Testing
  • Stability Testing & Storage
  • Monoclonal Antibody (mAb) Manufacturing
  • Biologics Development & Manufacturing
  • CMC Regulatory Submission Support
Modalities
  • Small Molecule
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
  • Cell Therapy
  • Gene Therapy
  • AAV / Viral Vector Platform
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
Indications
  • Oncology
  • Immunology
  • Neurology
  • Dermatology
Locations
  • Headquarters, United States
  • North America, North America
  • Europe, Europe
  • Asia, Asia
  • Durham, Durham, North Carolina, United States
  • Research Triangle Park, Research Triangle Park, North Carolina, United States
  • Boulder, Boulder, Colorado, United States
  • Louisville, Louisville, Colorado, United States
  • The Woodlands, The Woodlands, Texas, United States
  • Geneva, Geneva, Geneva, Switzerland
  • Leuven, Leuven, Flemish Brabant, Belgium
  • Hamlin Road, Durham, North Carolina, United States
  • Cell Line Development Center of Excellence, Geneva, Switzerland
Certifications
  • FDA · Identifier: 100 IND submissions containing Retrogenix® platform data
  • EMA · Identifier: 100 IND submissions containing Retrogenix® platform data
  • PMDA · Identifier: 100 IND submissions containing Retrogenix® platform data
  • EMA · Identifier: Retrogenix® platform data support
  • PMDA · Identifier: Retrogenix® platform data support
  • FDA · Identifier: cGMP
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.