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)
Bora Biologics
Products
Cell Line Development
Services to create high-yield, stable cell lines tailored for biologics production, including gene optimization and clone selection.
Mammalian Process Development
Optimization of mammalian cell culture and downstream processes to enhance biologics production from development to commercial scale.
Microbial Process Development
Development and optimization of microbial fermentation and purification processes for biologics production at various scales.
Analytical Development
Comprehensive analytical services for biologics characterization, method development, validation, and product quality assessment.
Formulation & Drug Product Development
Development of stable and effective formulations and drug products tailored to biologics, including pre-formulation screening and stability studies.
Tech Transfer
Management of technology transfer processes to ensure smooth transition from development to manufacturing with maintained product quality and compliance.
Cell Line Development
Services to create high-yield, stable cell lines tailored for biologics production, including gene optimization and clone selection.
Mammalian Process Development
Optimization of mammalian cell culture and downstream processes to enhance biologics production from development to commercial scale.
Microbial Process Development
Development and optimization of microbial fermentation and purification processes for biologics production at various scales.
Analytical Development
Comprehensive analytical services for biologics characterization, method development, validation, and product quality assessment.
Formulation & Drug Product Development
Development of stable and effective formulations and drug products tailored to biologics, including pre-formulation screening and stability studies.
Tech Transfer
Management of technology transfer processes to ensure smooth transition from development to manufacturing with maintained product quality and compliance.
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.