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Mammalian Drug-Substance Manufacturing with four 5,000 L Single-Use Bioreactor Trains

Mammalian Drug-Substance Manufacturing with four 5,000 L Single-Use Bioreactor Trains
Product Description

BE BioSol is expanding its mammalian drug-substance manufacturing capabilities with four 5,000 L single-use bioreactor trains, providing up to 20,000 L of total production capacity. The flexible, modular design will support efficient product changeover, parallel manufacturing campaigns and scalable production for monoclonal antibodies and other recombinant biologics.

The planned platform will support programs from process transfer and scale-up through validation and commercial manufacturing. Integrated teams will provide upstream and downstream process support, analytical-method transfer, process characterization, comparability assessments and regulatory documentation.

Single-use technology helps reduce changeover time and cross-contamination risk while providing the flexibility needed to respond to changing product demand.

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BIOLOGICAL E. LTD

  • Country/Region:
    India
  • On CPHI since:
    2015
  • Employees:
    5000+
Company types
Manufacturer/Innovator
View company profile
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Specifications
  • Details
    BE BioSol is expanding its mammalian drug-substance manufacturing capabilities with four 5,000 L single-use bioreactor trains, providing up to 20,000 L of total production capacity. The flexible, modular design will support efficient product changeover, parallel manufacturing campaigns and scalable production for monoclonal antibodies and other recombinant biologics.

    The planned platform will support programs from process transfer and scale-up through validation and commercial manufacturing. Integrated teams will provide upstream and downstream process support, analytical-method transfer, process characterization, comparability assessments and regulatory documentation.

    Single-use technology helps reduce changeover time and cross-contamination risk while providing the flexibility needed to respond to changing product demand. Combined with BE BioSol’s development, sterile drug-product and global regulatory capabilities,...

  • Selling Points
    FDA Approved, EMEA Approved 
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Sales Markets
Show more Show less

BIOLOGICAL E. LTD

  • Country/Region:
    India
  • On CPHI since:
    2015
  • Employees:
    5000+
Company types
Manufacturer/Innovator
View company profile

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