GMP manufacturing for cell culture products
Product Description
Bioworkshops
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Country/Region:China
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On CPHI since:2022
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Certificates:1
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Employees:100 - 249
Company types
Primary activities
Categories
Specifications
Bioworkshops
-
Country/Region:China
-
On CPHI since:2022
-
Certificates:1
-
Employees:100 - 249
Company types
Primary activities
More Products from Bioworkshops (67)
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Product Etesevimab
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 o... -
Product Evolocumab
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 o... -
Product Faricimab
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 o... -
Product Fremanezumab
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 o... -
Product Frunevetmab
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 o... -
Product Galcanezumab
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 o... -
Product Guselkumab
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 o... -
Product Hyaluronidase Recombinant Human
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 o... -
Product Imdevimab
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 o... -
Product Lanadelumab
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 o... -
Product Lecanemab
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 o... -
Product Lokivetmab
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 o...
Bioworkshops resources (5)
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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