Drug Substance Manufacturing

Drug Substance Manufacturing
Product Description

Modalities: monoclonal antibodies, recombinant proteins (including complex and non-cytotoxic conjugated), fusion proteins, enzymes, bispecifics, and plasma proteins 

Scale: single-use bioreactors 3L to 500L (development) and 50L to 2,000L (manufacturing) 

Stage coverage: preclinical and early phase, through commercial tech transfer 

Biosafety: BSL-1 and BSL-2 capable suites 

Network: drug substance is delivered at our Toronto, Canada site

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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
    Our biologics drug substance manufacturing and analytical development platforms are built for what the industry demands most: efficiency, quality, and flexibility. From early-phase process development through commercial supply, we manufacture biologics drug substance in single-use bioreactors up to 2,000L, in cGMP-certified, multi-product North American facilities. 
More specifications Fewer specifications

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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    Stage coverage: preclinical and early phase through la...
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    Product Device Assembly, Packaging & Logistics

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    Packaging: labeling, serialization, and aggregation across bulk, multi-u...
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    Product Parenteral Drug Product Manufacturing

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    Finishing: 100% visual inspection, device assembly, packaging, s...
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    Product Sterile Fill/Finish

    Formats: vials, pre-filled syringes, and cartridges 

    Fill technology: isolator- and RABS-based automated and semi-automated lines 

    Sites: Toronto and Cincinnati, both commercially licensed 

    Stage coverage: clinical and commercial, GMP and non-GMP 
    ...