Bora Biologics
Bora Biologics is a contract development and manufacturing organization (CDMO) providing end-to-end biologics development and GMP manufacturing services for mammalian and microbial modalities. Services include cell line development, upstream and downstream process development, analytical and formulation development, tech transfer, clinical-to-commercial GMP manufacturing, quality systems and supply chain support across facilities in San Diego (FDA-registered) and Zhubei, Taiwan (cGMP). The company reports ~14 years of biologics development and manufacturing experience and a multidisciplinary team of ~125 scientists and regulatory professionals. The organization also leverages partner CDMO resources to augment capacity and expertise.
Industries
Nr. of Employees
medium (51-250)
Products
Process Development
Mammalian process development services optimizing manufacturing processes to enhance product quality and reduce costs.
Microbial Process Development
Microbial process development services ensuring rapid and cost-effective production of microbial-derived biologics using optimized strain selection.
Integrated Biologics CDMO Services
End-to-end biopharmaceutical development and GMP manufacturing solutions spanning cell line development, process development, analytical testing, and commercial supply.
Full-Service Biologics Manufacturing
Comprehensive FDA-inspected, single-use GMP manufacturing platform supporting monoclonal antibodies, bispecifics, and advanced biologics from early clinical through commercial supply.
Mammalian GMP Manufacturing
Precision and excellence in mammalian cell culture utilizing advanced single-use technologies and robust quality management systems.
2000L Single-Use Commercial Capacity
Expanded 2000L single-use capabilities supporting late-stage development and commercial GMP manufacturing in a San Diego FDA registered facility.
Process Development
Mammalian process development services optimizing manufacturing processes to enhance product quality and reduce costs.
Microbial Process Development
Microbial process development services ensuring rapid and cost-effective production of microbial-derived biologics using optimized strain selection.
Integrated Biologics CDMO Services
End-to-end biopharmaceutical development and GMP manufacturing solutions spanning cell line development, process development, analytical testing, and commercial supply.
Full-Service Biologics Manufacturing
Comprehensive FDA-inspected, single-use GMP manufacturing platform supporting monoclonal antibodies, bispecifics, and advanced biologics from early clinical through commercial supply.
Mammalian GMP Manufacturing
Precision and excellence in mammalian cell culture utilizing advanced single-use technologies and robust quality management systems.
2000L Single-Use Commercial Capacity
Expanded 2000L single-use capabilities supporting late-stage development and commercial GMP manufacturing in a San Diego FDA registered facility.
Services
End-to-end biologics development services including upstream/downstream process development, analytical method development and formulation/drug-product development from early discovery to first-in-human.
Structured technology transfer and manufacturing science & technology support to transition processes into cGMP manufacturing and enable scalable, reproducible commercial production.
Host cell selection, gene optimization and clone characterization to produce high-titer, stable production cell lines.
cGMP clinical and commercial production for mammalian and microbial drug substance using single-use and stainless-steel systems across multiple suites and scales.
Method development, qualification and routine QC testing for identity, purity, potency and release testing using chromatography, mass spectrometry, electrophoresis and cell-based assays.
High-throughput pre-formulation, biophysical screening, stability and packaging compatibility to support drug product design and commercialization.
End-to-end biologics development services including upstream/downstream process development, analytical method development and formulation/drug-product development from early discovery to first-in-human.
Structured technology transfer and manufacturing science & technology support to transition processes into cGMP manufacturing and enable scalable, reproducible commercial production.
Host cell selection, gene optimization and clone characterization to produce high-titer, stable production cell lines.
cGMP clinical and commercial production for mammalian and microbial drug substance using single-use and stainless-steel systems across multiple suites and scales.
Method development, qualification and routine QC testing for identity, purity, potency and release testing using chromatography, mass spectrometry, electrophoresis and cell-based assays.
High-throughput pre-formulation, biophysical screening, stability and packaging compatibility to support drug product design and commercialization.
Expertise Areas
- End-to-end biologics development and manufacturing (CDMO services)
- Mammalian cell culture and microbial fermentation
- Cell line development and host cell bank qualification
- Upstream and downstream process development and scale-up
Key Technologies
- Single-use bioreactors
- Stainless-steel fermentors
- Automated tangential flow filtration (TFF) systems
- Chromatography systems (AKTA-compatible workflows)
News & Updates
Exhibiting at BIO International Convention, Booth #2087 and Taiwan Pavilion presence.
Press release announcing expansion of San Diego GMP space and installation of 2000 L single-use bioreactors to increase commercial manufacturing capacity.
Announcement describing a strategic alliance that provides access to additional CDMO resources and shared expertise to support development and manufacturing programs.
Planned installation of two 2000 L single-use bioreactors and facility expansion to support commercial-scale biologics manufacturing; upstream design allows future expansion to 5000 L.
More than 100 successful cGMP batches delivered and continuous 100% success rate for 70+ cGMP batches at Zhubei facility since 2014.
Company-stated operating experience spanning approximately 14 years in biologics development and manufacturing.
Exhibiting at BIO International Convention, Booth #2087 and Taiwan Pavilion presence.
Press release announcing expansion of San Diego GMP space and installation of 2000 L single-use bioreactors to increase commercial manufacturing capacity.
Announcement describing a strategic alliance that provides access to additional CDMO resources and shared expertise to support development and manufacturing programs.
Planned installation of two 2000 L single-use bioreactors and facility expansion to support commercial-scale biologics manufacturing; upstream design allows future expansion to 5000 L.
More than 100 successful cGMP batches delivered and continuous 100% success rate for 70+ cGMP batches at Zhubei facility since 2014.
Company-stated operating experience spanning approximately 14 years in biologics development and manufacturing.