Bionova Scientific LLC
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
small (1-50)
Bionova Scientific LLC
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
Development of research cell banks and clonally stable master cell banks, screening and optimization to produce productive cell lines for manufacturing.
Clone/media/process screening, fed-batch and perfusion process development, seed train optimization, production media development, and tech transfer support.
Capture and polishing process design, viral inactivation/filtration, UF/DF, filter sizing, process verification at scale and support for ADC and other complex molecules.
Method development, qualification, routine QC testing and product characterization including stability studies, binding and potency assays, and QC support for GMP operations.
High-throughput formulation screening, DOE-based optimization, biophysical characterization, forced degradation and long-term stability studies, and container compatibility testing.
Process development and manufacturing of plasmid DNA for RUO, high-quality and GMP use, including fermentation, downstream processing, formulation, and GMP batch production.
Development of research cell banks and clonally stable master cell banks, screening and optimization to produce productive cell lines for manufacturing.
Clone/media/process screening, fed-batch and perfusion process development, seed train optimization, production media development, and tech transfer support.
Capture and polishing process design, viral inactivation/filtration, UF/DF, filter sizing, process verification at scale and support for ADC and other complex molecules.
Method development, qualification, routine QC testing and product characterization including stability studies, binding and potency assays, and QC support for GMP operations.
High-throughput formulation screening, DOE-based optimization, biophysical characterization, forced degradation and long-term stability studies, and container compatibility testing.
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
News & Updates
Webinar presented by a company scientist covering plasmid DNA process topics; registration link provided.
Announcement describing updates to the company's quality culture and program.
Announcement of a licensing agreement to adopt a transposon-based gene delivery system to accelerate cell line development workflows.
Announcement naming a preferred third-party provider for mycoplasma testing to support biologics manufacturing programs.
Announcement detailing plans for a dedicated plasmid DNA GMP facility and related capabilities.
Webinar presented by a company scientist covering plasmid DNA process topics; registration link provided.
Announcement describing updates to the company's quality culture and program.
Announcement of a licensing agreement to adopt a transposon-based gene delivery system to accelerate cell line development workflows.
Announcement naming a preferred third-party provider for mycoplasma testing to support biologics manufacturing programs.
Announcement detailing plans for a dedicated plasmid DNA GMP facility and related capabilities.