Bioworkshops

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...

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...

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...

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...

Target: SARS-CoV-2 S protein CAS: 2578319-11-4

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...

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...

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...

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...

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...

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...

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...

Overview of Bioworkshops for development, GMP manufacturing, and regulatory assurance for antibody therapeutics

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.

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

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.

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