BiosanaPharma
BiosanaPharma is a biotechnology company dedicated to making biologics, especially monoclonal antibody therapeutics, more affordable and accessible through innovative, disruptive technology. They focus on continuous manufacturing processes to reduce costs and increase efficiency, aiming to improve global patient access to biologic medicines.
Industries
Nr. of Employees
small (1-50)
BiosanaPharma
J.H. Oortweg 21, 2333 CH Leiden, The Netherlands
Products
3C continuous manufacturing automation platform
A biodigital automation platform for continuous biomanufacturing (the '3C' platform) combining multicycle upstream and downstream unit operations, PAT integration, system-health dashboards and AI/ML-enabled analytics; designed for small-footprint, single-use operation at 50–2000 L scales.
Oral protein nanoparticle delivery platform
An oral delivery approach that encapsulates proteins into nanoparticles via supercritical CO2 spray drying, delivers them in enteric-coated capsules to the duodenum and aims to enable intestinal uptake of functional proteins; preclinical studies reported higher oral bioavailability versus subcutaneous dosing in test compounds.
3C continuous manufacturing automation platform
A biodigital automation platform for continuous biomanufacturing (the '3C' platform) combining multicycle upstream and downstream unit operations, PAT integration, system-health dashboards and AI/ML-enabled analytics; designed for small-footprint, single-use operation at 50–2000 L scales.
Oral protein nanoparticle delivery platform
An oral delivery approach that encapsulates proteins into nanoparticles via supercritical CO2 spray drying, delivers them in enteric-coated capsules to the duodenum and aims to enable intestinal uptake of functional proteins; preclinical studies reported higher oral bioavailability versus subcutaneous dosing in test compounds.
Services
Licensing of continuous manufacturing automation and onsite implementation services for downstream processing, including equipment procurement, automatic sampling, on/at-line analytics, batch-to-continuous design, installation, commissioning and personnel training.
Field lab service to set up and test continuous process trains at target production scales, simulate unit operations, validate integrated system function, train personnel and prepare processes for transfer to client facilities.
Collaborative research engagements for downscaling, PAT development, scale-up modelling and high-throughput process development executed in joint laboratories with research institutes.
Technical transfer of continuous processes to client sites with oversight of installation and commissioning, plus provision of validation documentation templates to support GMP compliance.
Co-development and exclusive licensing arrangements for biosimilar monoclonal antibody candidates including support for analytical, clinical comparability studies and regulatory-enabling activities.
Licensing of continuous manufacturing automation and onsite implementation services for downstream processing, including equipment procurement, automatic sampling, on/at-line analytics, batch-to-continuous design, installation, commissioning and personnel training.
Field lab service to set up and test continuous process trains at target production scales, simulate unit operations, validate integrated system function, train personnel and prepare processes for transfer to client facilities.
Collaborative research engagements for downscaling, PAT development, scale-up modelling and high-throughput process development executed in joint laboratories with research institutes.
Technical transfer of continuous processes to client sites with oversight of installation and commissioning, plus provision of validation documentation templates to support GMP compliance.
Co-development and exclusive licensing arrangements for biosimilar monoclonal antibody candidates including support for analytical, clinical comparability studies and regulatory-enabling activities.
Expertise Areas
- Continuous biomanufacturing
- Downstream purification process development
- Upstream perfusion culture
- Process Analytical Technology (PAT) and real-time monitoring
Key Technologies
- Continuous manufacturing platforms
- Simulated moving bed chromatography
- Flow-through filtration
- High cell density perfusion culture
News & Updates
BiosanaPharma has successfully developed a CM overarching automation platform for 24/7 mAb and non mAb protein manufacturing under GMP, enabling more output at lower costs.
Alvotech enters exclusive global licensing agreement with BiosanaPharma for co-development of a proposed biosimilar to Xolair (omalizumab).
BiosanaPharma reports successful phase I clinical trial results for BP001, a biosimilar candidate to Xolair, produced via fully continuous manufacturing process.
BiosanaPharma launches a comprehensive automation platform for continuous manufacturing of biologics, aiming to increase output and reduce costs.
A collaboration to bring continuous biomanufacturing to the next level, using Biosana’s proprietary 3C process, to lower costs and improve accessibility of mAb therapeutics.
BiosanaPharma is implementing a step-by-step approach to adopt Bioprocessing 4.0, lowering costs through continuous manufacturing and process analytical technologies.
BiosanaPharma has successfully developed a CM overarching automation platform for 24/7 mAb and non mAb protein manufacturing under GMP, enabling more output at lower costs.
Alvotech enters exclusive global licensing agreement with BiosanaPharma for co-development of a proposed biosimilar to Xolair (omalizumab).
BiosanaPharma reports successful phase I clinical trial results for BP001, a biosimilar candidate to Xolair, produced via fully continuous manufacturing process.
BiosanaPharma launches a comprehensive automation platform for continuous manufacturing of biologics, aiming to increase output and reduce costs.
A collaboration to bring continuous biomanufacturing to the next level, using Biosana’s proprietary 3C process, to lower costs and improve accessibility of mAb therapeutics.
BiosanaPharma is implementing a step-by-step approach to adopt Bioprocessing 4.0, lowering costs through continuous manufacturing and process analytical technologies.