Casirivimab

Casirivimab
Product Description

Regulatory compliance: Developed from a cell line with DMF filing, ensuring global regulatory readiness and streamlined submissions.

High titer: Optimized cell line and process deliver consistently strong productivity, supporting cost-efficient large-scale manufacturing.

High degree of similarity: Proven analytical comparability to the reference product, ensuring regulatory and clinical acceptance.

Favorable license terms: Flexible, partner-friendly licensing framework designed to accelerate collaboration.

Broad media adaptability: Cell line performs robustly across multiple media platforms, facilitating scalable and transferable upstream development.

Bioworkshops

  • Country/Region:
    China
  • On CPHI since:
    2022
  • Certificates:
    1
  • Employees:
    100 - 249
Company types
CMO/CDMO
Start-up
Primary activities
Biopharmaceutical
Specifications
  • CAS Registry Number
    2415933-42-3
  • Details
    Name: Casirivimab
    Target: SARS-CoV-2 S protein
    CAS No.: 2415933-42-3
    Type: mAb (SARS-CoV-2 S protein inhibitor)
    Originator Organization: Roche Registration GmbH; Regeneron Pharmaceuticals, Inc.
    Approval: 2020-11-21, United States
    Application areas: Infectious diseases, respiratory diseases, etc.
    Representative indication: COVID-19

  • Selling Points
    Regulatory compliance: Developed from a cell line with DMF filing, ensuring global regulatory readiness and streamlined submissions.

    High titer: Optimized cell line and process deliver consistently strong productivity, supporting cost-efficient large-scale manufacturing.

    High degree of similarity: Proven analytical comparability to the reference product, ensuring regulatory and clinical acceptance.

    Favorable license terms: Flexible, partner-friendly licensing framework designed to accelerate collaboration.

    Broad media adaptability: Cell line performs robustly across multiple media platforms, facilitating scalable and transferable upstream development.

Bioworkshops

  • Country/Region:
    China
  • On CPHI since:
    2022
  • Certificates:
    1
  • Employees:
    100 - 249
Company types
CMO/CDMO
Start-up
Primary activities
Biopharmaceutical

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Bioworkshops resources (5)

  • Brochure Bioworkshops reliable antibody CDMO

    Overview of Bioworkshops for development, GMP manufacturing, and regulatory assurance for antibody therapeutics
  • Brochure Aseptic filling of biologics in liquid or lyophilized formats

    Bioworkshops services for aseptic filling include:Formulation development for liquid and lyophilized formatsManufacturing in compliance with Annex 1 requirementsBatch testing and releaseExecution of accelerated and long-term ICH stability studies 
    Development services include high-concentration formulations (to 200 mg/mL), lyophilization cycle development, and stress stability studies.


    Flexibility for clinical and commercial batches with three aseptic filling lines covering vials, PFS, and cartridges with validated batch sizes to 40,000 units.
  • Brochure Robust Cell Line Development by Bioworkshops

    High-productivity, stable CHO cell lines for clinical and commercial expression of therapeutic proteins: mAbs, bsAbs, fusion-proteins, TCRs, TCEs, naked ADCs and biosimilars.
    The Bioworkshops cell line development service offers choice of robust, royalty-free options for commercial production based on readily-available commercial media and supplements


    Over 200 stable cell lines have been produced for multiple product formats:
    Guaranteed stable to at least 60 PDLTiter to 12 g/LHost cell line DMF
  • Video Bioworkshops Drug Substance Manufacturing

    Virtual tour and description of Bioworkshops multiproduct cleanroom suites for manufacturing drug substance based on recombinant cell culture.
    Seed labsBioreactor halls with 50 - 2,000 L reactorsHarvest roomsPurificationSupport services for liquid and materials handlingAlso provides a summary of application experience.
  • Video Bioworkshops trio of aseptic oRABS filling lines

    Virtual tour of the three state-of-the-art aseptic filling lines operated at Bioworkshops in full compliance with Annex 1 requirements:Commerical-scale 200/min vial line for liquid and lyophilized products (2R - 50R)10,000/hr PFS/Cartridge line (long-format and standard)Ultra-low hold-up vial line for clinical batches