Large Molecule Biologics Development

Large Molecule Biologics Development
Product Description

Modalities: monoclonal antibodies, Fab fragments, Fc fusion proteins, recombinant proteins, and ADC intermediates 

Scale: pilot-scale single-use bioreactors from 3 L to 500 L for process development and characterization 

Stage coverage: preclinical and early phase through late-stage and commercial tech transfer readiness 

Sites: process and analytical development at our Toronto facility, drug product testing and stability support at our Cincinnati facility 

Network: entirely within our North American footprint 

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Resilience

  • Country/Region:
    United States
  • Founded:
    2020
  • On CPHI since:
    2023
  • Certificates:
    4
  • Employees:
    1000 - 4999
Company types
Biopharmaceutical company
CMO/CDMO
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Pharmaceutical company
Primary activities
Analytical Services
Biopharmaceutical
Contract Manufacturer
Intermediates Manufacturer
Packaging & drug delivery
Pharmaceutical Company (innovator finished products)
Supply Chain
Technology
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Categories
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Specifications
  • Details
    Development and Analytical covers the work that happens before a molecule reaches commercial-scale GMP production: choosing or receiving a cell line, building and characterizing the upstream and downstream process, and developing and validating the analytical methods that will test it at every stage after. 
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Resilience

  • Country/Region:
    United States
  • Founded:
    2020
  • On CPHI since:
    2023
  • Certificates:
    4
  • Employees:
    1000 - 4999
Company types
Biopharmaceutical company
CMO/CDMO
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Pharmaceutical company
Primary activities
Analytical Services
Biopharmaceutical
Contract Manufacturer
Intermediates Manufacturer
Packaging & drug delivery
Pharmaceutical Company (innovator finished products)
Supply Chain
Technology
View company profile

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