Bionova Scientific
Biologics CDMO offering development and manufacturing services for recombinant protein therapeutics and plasmid DNA. Services include cell line development, upstream and downstream process development, pilot and GMP manufacturing (clinical and commercial), analytical method development and qualification, formulation development, plasmid DNA process development and GMP manufacture, and quality/validation support. Facilities support research through clinical-stage programs and regulatory filings.
Industries
Nr. of Employees
medium (51-250)
Bionova Scientific
Fremont, Ohio, United States, North America
Products
Biologics CDMO Services
Contract development and manufacturing services for monoclonal antibodies and therapeutic proteins using mammalian cell culture processes.
Cell Line Development Using ATUM’s Leap-In Transposase® Technology
Cell line development service employing transposon-based gene delivery to improve gene integration and productivity in stable cell lines.
Plasmid DNA (pDNA) Development and Manufacturing
Development and production of research grade and GMP plasmid DNA to support cell and gene therapy and recombinant protein therapeutics.
Analytical Sciences and Services
Analytical testing and scientific support to ensure quality and efficiency in biologics development and manufacturing.
Mycoplasma Testing Services (via Bionique Testing Laboratories)
Mycoplasma contamination testing services supporting biologics manufacturing processes.
Biologics CDMO Services
Contract development and manufacturing services for monoclonal antibodies and therapeutic proteins using mammalian cell culture processes.
Cell Line Development Using ATUM’s Leap-In Transposase® Technology
Cell line development service employing transposon-based gene delivery to improve gene integration and productivity in stable cell lines.
Plasmid DNA (pDNA) Development and Manufacturing
Development and production of research grade and GMP plasmid DNA to support cell and gene therapy and recombinant protein therapeutics.
Analytical Sciences and Services
Analytical testing and scientific support to ensure quality and efficiency in biologics development and manufacturing.
Mycoplasma Testing Services (via Bionique Testing Laboratories)
Mycoplasma contamination testing services supporting biologics manufacturing processes.
Services
Cell line development services
Development of research cell banks and clonally stable master cell banks, screening and optimization to produce productive cell lines for manufacturing.
Upstream process development and optimization
Clone/media/process screening, fed-batch and perfusion process development, seed train optimization, production media development, and tech transfer support.
Downstream process development and purification
Capture and polishing process design, viral inactivation/filtration, UF/DF, filter sizing, process verification at scale and support for ADC and other complex molecules.
Analytical sciences and testing
Method development, qualification, routine QC testing and product characterization including stability studies, binding and potency assays, and QC support for GMP operations.
Formulation development
High-throughput formulation screening, DOE-based optimization, biophysical characterization, forced degradation and long-term stability studies, and container compatibility testing.
Plasmid DNA development and manufacturing
Process development and manufacturing of plasmid DNA for RUO, high-quality and GMP use, including fermentation, downstream processing, formulation, and GMP batch production.
Cell line development services
Development of research cell banks and clonally stable master cell banks, screening and optimization to produce productive cell lines for manufacturing.
Upstream process development and optimization
Clone/media/process screening, fed-batch and perfusion process development, seed train optimization, production media development, and tech transfer support.
Downstream process development and purification
Capture and polishing process design, viral inactivation/filtration, UF/DF, filter sizing, process verification at scale and support for ADC and other complex molecules.
Analytical sciences and testing
Method development, qualification, routine QC testing and product characterization including stability studies, binding and potency assays, and QC support for GMP operations.
Formulation development
High-throughput formulation screening, DOE-based optimization, biophysical characterization, forced degradation and long-term stability studies, and container compatibility testing.
Plasmid DNA development and manufacturing
Process development and manufacturing of plasmid DNA for RUO, high-quality and GMP use, including fermentation, downstream processing, formulation, and GMP batch production.
Expertise Areas
- Cell line development
- Upstream process development and perfusion
- Downstream process development and purification
- Pilot-scale production and GMP scale-up
Key Technologies
- Mammalian cell culture (CHO, HEK293)
- High-throughput microbioreactor systems
- Single-use stirred-tank bioreactors (bench to 2000 L)
- Perfusion systems with ATF/TFF