Bionova Scientific

What Bionova Scientific does

Bionova Scientific is a US-based biologics contract development and manufacturing organization (CDMO) founded in 2014 and headquartered in Fremont, California. The company provides end-to-end development and GMP manufacturing services for recombinant protein therapeutics — monoclonal antibodies, bispecifics, ADCs, Fc-fusion proteins, and complex mammalian-cell-produced biologics — using mammalian cell culture (CHO-based) processes, with GMP capacity at up to 2,000L single-use scale. In 2024 the company expanded into plasmid DNA (pDNA) development and manufacturing through a dedicated facility in The Woodlands, Texas, supporting cell therapies, gene therapies, and mRNA-based therapeutics.

Service offerings are organized into R&D, development, manufacturing, and support modules — including cell line development (using ATUM's licensed Leap-In transposase technology), upstream and downstream process development, analytical sciences, formulation development, pilot and GMP manufacturing, process characterization studies, and quality assurance/control. The pDNA platform is built on a proprietary IS-free host architecture and exclusive access to Scarab Genomics' Clean Genome E. coli strains, supplemented by the Syenex OTS LVV system for lentiviral vector applications. Asahi Kasei Medical acquired Bionova in June 2022; the company now operates as a wholly-owned subsidiary combining boutique CDMO agility with the capital and integration benefits of a global Japanese conglomerate.

Bionova serves three primary customer segments: top-10 global biopharmaceutical companies requiring commercial-ready biologics manufacturing; mid-to-large biopharma firms needing overflow capacity or specialized expertise for difficult-to-express proteins; and virtual or emerging biotech firms needing end-to-end turnkey services. Revenue is generated through quote-based, multi-year project contracts with milestone billing across R&D, development, and GMP manufacturing scopes. GTM is enterprise field sales driven by senior business development leadership, supported by scientific project managers and an event-led marketing presence across major biopharma and cell/gene therapy conferences.

Name

Bionova Scientific

Legal name

Bionova Scientific LLC

Website

https://bionovascientific.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

Bionova Scientific is a US biologics and plasmid DNA CDMO offering end-to-end cell line development, process development, and GMP manufacturing for recombinant proteins and genetic medicine starting materials, serving top-10 global biopharmas, mid-market biopharma, and virtual biotech firms from facilities in Fremont, CA and The Woodlands, TX, as a subsidiary of Asahi Kasei Corporation.

Ownership category

akta.pro rank

Product category

Biologics Contract Development and Manufacturing (CDMO)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834)

akta.pro primary industry

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

akta.pro secondary industries

mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), mRNA/LNP & Nucleic Acid Therapeutics CDMO (HLAGABAF)

Keywords

• Biologics CDMO services
• Cell line development
• GMP biologics manufacturing
• Plasmid DNA production
• Process development services

Headquarters

HQ city

Fremont

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales, Supply Chain

Revenue model

1. Biologics CDMO Services: End-to-end contract development and manufacturing services for recombinant protein therapeutics using mammalian cell culture. Revenue is earned through project-based fees across R&D services (cell line development, protein production, analytical sciences), development services (upstream PD, downstream PD, formulation), manufacturing services (pilot production, GMP manufacturing, process characterization), and support services (quality, QC, project management). Typically structured as multi-year contracts with milestone-based billing.
2. Plasmid DNA CDMO Services: Development and manufacturing of plasmid DNA (pDNA) for RUO, High-Quality (HQ), and GMP applications targeting cell therapies, gene therapies, and mRNA therapeutics. Revenue from strain development, process development, method development, formulation, and material production across scales.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Bionova Scientific is a biologics Contract Development and Manufacturing Organization (CDMO) that provides end-to-end development and GMP manufacturing services for recombinant protein therapeutics using mammalian cell culture processes, including monoclonal antibodies and other therapeutic proteins. The company also develops and manufactures plasmid DNA (research grade, high-quality, and GMP) for cell therapies, gene therapies, and mRNA-based therapeutics through its proprietary IS-free platform. Services span cell line development, upstream and downstream process development, analytical sciences, formulation, pilot production, GMP manufacturing up to 2000L scale, process characterization, quality control, and program management.

Product overview

Bionova Scientific is a biologics CDMO (Contract Development and Manufacturing Organization) offering end-to-end development and GMP manufacturing services for recombinant proteins and plasmid DNA. The company operates as a single integrated platform with multiple specialized service modules including: Cell Line Development (using ATUM Leap-In Transposase technology), Upstream/Downstream Process Development, Analytical Sciences, Formulation Development, GMP Manufacturing (up to 2000L scale), Pilot Scale Production, Process Characterization Studies, and Quality Control/Assurance. For plasmid DNA, the company offers RUO, High-Quality, and GMP materials through its proprietary IS-free platform combined with Scarab Genomics Clean Genome E. coli technology and Syenex delivery systems. The biologics operations focus on mammalian cell culture processes for monoclonal antibodies and therapeutic proteins, while plasmid DNA services support cell therapies (CAR-T), gene therapies (AAV), and mRNA-based therapeutics. Facilities include headquarters and biologics manufacturing in Fremont, California and plasmid DNA operations in The Woodlands, Texas. Founded in 2014 and acquired by Asahi Kasei in 2022.

Differentiator

Problem solved

Functional benefit

Products and services

• Plasmid DNA Development & Manufacturing End-to-end development and manufacturing of plasmid DNA (pDNA) for Research Use Only (RUO), High-Quality (HQ), and GMP applications, supporting cell therapies (CAR-T, autologous, allogeneic), gene therapies (AAV), mRNA-based therapeutics, and lentiviral vector production. Features proprietary IS-free host architecture, Scarab Genomics Clean Genome E. coli strains (exclusive license), Thomson Ultra Yield System, and Syenex OTS LVV System. Operations based at the 10,000 sq. ft. The Woodlands, Texas facility with 2L (RUO) and 50L (HQ/GMP) fermentation scale.
• Cell Line Development Mammalian cell line development services using ATUM's Leap-In Transposase technology for high gene integration, precise single-copy genomic integration, and reduced gene silencing risk. Develops robust, high-productivity cell lines including CHO and HEK 293 systems for clients developing recombinant protein therapeutics. Routinely achieves titers up to 10 g/L.
• Upstream Process Development Advanced upstream process development and optimization services for mammalian cell culture, including clone screening, media screening, process characterization, fed-batch and perfusion processes. Features Ambr high-throughput microbioreactor systems and extensive bioreactor capacity.
• Downstream Process Development Rapid development of robust downstream processes to maximize yields and minimize impurity content. Features Cytiva Akta systems for protein capture (Protein A, G, L, Nickel), polishing (AEX/CEX columns), and viral filtration with extensive MSAT experience in scale-up.
• Analytical Sciences Comprehensive analytical support including method development, qualification, product quality assessment, stability studies, and protein characterization. Broad assay repertoire for titer determination, purity testing, glycan profiling, and potency assays (ADCC, CDC).
• Formulation Development Successful development of formulations for mAb, Fab, ADC, bispecific, enzyme, and complex biologics. High-throughput DOE platforms for rapid effect screening, thermal stability assessment, solubility/aggregation evaluation, and real-time long-term formulation stability studies.
• GMP Manufacturing Commercial-ready GMP biologics manufacturing with state-of-the-art single-use technology. Manufacturing slots available up to 2000L scale using Cytiva XDR bioreactors and FlexFactory platform. Achieved successful QP inspection in 2022 for EU clinical supply, with experience in FDA, EMEA, KFDA, ANVISA, PMDA, and CFIA regulatory filings.
• Pilot Scale Production Pilot scale production services for pre-clinical toxicology studies and process scale-up at bioreactor scales of 50L or higher. Provides GLP material for IND-enabling studies with full batch records and QA oversight. Features Cytiva XDR 500L, Thermo Fisher SUB 250L, and Pall 200L bioreactors.
• Process Characterization Studies World-class process characterization studies combining technical expertise, rapid execution, and robust infrastructure. FlexPCS offering enables deployment of Bionova team for discrete pieces of PCS projects with full analytics tailored to program, schedule, and budget.
• Protein Production Services Rapid protein production using transient or stable transfected CHO and HEK 293 cells for proof-of-concept activities up to gram quantities. Scalable from bench shake flasks to 50L bioreactors with standard or customized downstream processes.

Quantifiable outcome

• Titers up to 10 g/L achieved routinely in cell line development programs
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Four partnerships are on record, tiered core and preferred provider.

• Scarab GenomicscoreTechnology or Integration · 4 February 2026Exclusive licensing partnership granting Bionova rights to use Scarab's proprietary Clean Genome engineered E. coli strains for plasmid DNA production. The Clean Genome platform eliminates mobile genetic elements and minimizes genomic instability to achieve higher plasmid yields and improved lot-to-lot consistency. The partnership enables Bionova to support client programs across mRNA, viral vectors, and emerging genetic medicine platforms with scalable, regulatory-aligned manufacturing solutions.
• SyenexcoreStrategic or Co-development Partner · 8 January 2026Strategic manufacturing alliance combining Bionova's proprietary IS-free plasmid DNA manufacturing platform with Syenex's delivery technologies to address critical bottlenecks in pricing, quality, and supply-chain reliability for pDNA. Bionova serves as preferred manufacturing partner for Syenex's delivery platforms. The alliance enables therapeutic developers to progress from early-stage RUO plasmids through GMP manufacturing with reduced comparability risk and improved lentiviral vector manufacturability.
• ATUMcoreTechnology or Integration · 7 May 2025Bionova licensed ATUM's proprietary Leap-In Transposase transposon-based gene delivery technology and miCHO cell line development technologies. Leap-In technology provides high-frequency gene integration with precise single-copy insertion, reducing gene silencing risk and streamlining cell line development workflows with shortened timelines.
• Bionique Testing Laboratoriespreferred providerTechnology or Integration · 20 March 2025Bionique Testing Laboratories appointed as preferred provider for mycoplasma testing services for biologics manufacturing. Both Bionova and Bionique are subsidiaries of Asahi Kasei Corporation's medical division, enabling integrated service delivery for Bionova's biologics clients.

Scale indicators6 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• LakePharma (Curia): Mid-sized biologics CDMO with similar scale and service mix in mammalian cell line development, process development, and GMP manufacturing for recombinant proteins. Comparable niche positioning in the US CDMO market.
• Abzena: Biologics CDMO specializing in antibody and complex protein development and manufacturing, including bispecifics and ADCs. Directly comparable service overlap with Bionova's biologics offerings; Bionova's SVP of Global BD Sven Lee held prior roles at Abzena.
• Genezen: Viral vector and plasmid DNA CDMO focused on lentiviral and AAV gene therapy manufacturing. Directly comparable on the pDNA/lentiviral vector supply side; Bionova's GM/VP of pDNA Pratima Cherukuri was previously CSO at Genezen.
• AGC Biologics: Global biologics CDMO providing cell line development, process development, and GMP manufacturing for mAbs and recombinant proteins. Comparable in scope of services and mammalian cell culture focus, with broader global footprint.
• Cytovance Biologics: Mid-sized biologics CDMO offering mammalian cell culture development and GMP manufacturing for recombinant proteins. Highly comparable in scale, service offering, and customer profile; notably, Bionova's Chairman/CEO Darren Head previously led Cytovance prior to its acquisition by Hepalink.
• Centre for Breakthrough Medicines: Cell and gene therapy CDMO offering plasmid DNA, viral vector, and cell therapy manufacturing. Comparable on the pDNA side of Bionova's business; Bionova's VP Supply Chain Ruben Omega previously served as Director of Planning there.

Broad incumbents

• Catalent Biologics: Large-scale global biologics CDMO offering mammalian cell line development and GMP manufacturing across multiple sites. A much larger competitor; Bionova's Chairman/CEO Darren Head previously led MaSTherCell into its acquisition by Catalent.
• Samsung Biologics: One of the world's largest biologics CDMOs with multi-100,000L total bioreactor capacity. Represents the large-scale incumbent benchmark against which Bionova's boutique positioning is differentiated.
• WuXi Biologics: Global top-tier biologics CDMO with very large mammalian-cell GMP capacity and end-to-end services. Sets the scale and cost benchmark for biologics CDMO services, including those Bionova competes against.
• Boehringer Ingelheim BioXcellence: Tier-1 global biologics CDMO with mammalian cell culture process development and large-scale GMP manufacturing. Competes directly with Bionova in biologics CDMO services, with multiple Bionova leaders (founders Amy Kong, Chung Chun; VP Minni Aswath) coming from BI.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bionova-scientific

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Bionova Scientific