Bionique Testing Laboratories
Bionique Testing Laboratories is a GMP FDA-registered contract research organization in Saranac Lake, NY, providing specialized mycoplasma testing services to biopharmaceutical manufacturers, CDMOs, and cell and gene therapy developers, operating as a subsidiary of Asahi Kasei Medical.
- Company typePrivate
- Founded1990
- HeadquartersSaranac Lake, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Bionique Testing Laboratories does
Bionique Testing Laboratories LLC is a GMP FDA-registered contract research organization founded in 1990 and headquartered in Saranac Lake, New York, specializing exclusively in mycoplasma testing services for the biopharmaceutical industry. The company operates a single-site laboratory that recently completed a ~35,000 sq ft expansion (Grand Opening September 26, 2025) and is a wholly-owned subsidiary of Asahi Kasei Medical Co., Ltd. following a December 15, 2021 acquisition; it sits within Asahi Kasei Medical's Bioprocess Division alongside Austria-based sister company ViruSure GmbH.
The core technology portfolio combines classical compendial methods (Harmonized USP <63> / FDA Points to Consider / Ph. Eur. 2.6.7 / Japanese Pharmacopoeia) with a proprietary hybrid Real-Time PCR assay with broth enrichment (M-1500) that compresses 28-day compendial testing into 3-6 days while maintaining comparable sensitivity. The company also offers three proprietary mycoplasma media formulations, an automated DNA extraction workflow (AutoMate Express) that yields ~16% time savings and 45% throughput uplift, matrix qualification (M-1500Q), product-specific suitability studies (M-1550), and a broader assay development, validation, and transfer service line covering cell banks, raw materials, lot release, recombinant proteins, gene therapies, cell therapies, vaccines, and in vitro diagnostics.
Bionique generates revenue through professional services on a quote-based, pay-as-you-go contract testing model with optional expedited service tiers. The go-to-market is consultative B2B field sales combined with event-driven demand generation (Biotech Week Boston, Advanced Therapies Week, PDA Week, ASGCT, PDA Pharmaceutical Microbiology Conference) and content marketing. Customer base is concentrated in biopharmaceutical manufacturers, CDMOs, vaccine producers, and cell/gene therapy developers; recently named enterprise customers include Abeona Therapeutics, Cellipont Bioservices, and Bionova Scientific (a sister CDMO). Distribution is exclusively direct, with online sample submission forms and direct technical engagement by laboratory scientists.
Bionique Testing Laboratories firmographics
Firmographics- Name
- Bionique Testing Laboratories
- Legal name
- Bionique Testing Laboratories LLC
- Website
- https://bionique.com
- Company type
- Private
- Founded year
- 1990
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Bionique Testing Laboratories is a GMP FDA-registered contract research organization in Saranac Lake, NY, providing specialized mycoplasma testing services to biopharmaceutical manufacturers, CDMOs, and cell and gene therapy developers, operating as a subsidiary of Asahi Kasei Medical.
- Ownership category
- akta.pro rank
Bionique Testing Laboratories industry classification
Industry- Product category
- Mycoplasma Testing Services
- NAICS
- Testing Laboratories and Services (541380), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Analytical Testing & QC Release Services (potency, purity, sterility) (HLAAAKAG)
- akta.pro secondary industries
- Cell-Based & Potency Assays (Bioassays) (HLAGADAH), Microbiology & Infectious Disease Testing Laboratories (HLAFAMAD)
Keywords
Where Bionique Testing Laboratories is headquartered
LocationHeadquarters
- HQ city
- Saranac Lake
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Bionique Testing Laboratories business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Others
Revenue model
- Mycoplasma Testing Services: Bionique generates revenue through laboratory testing services including cell culture testing, raw materials testing, and lot release testing. Testing services follow GMP-compliant protocols and regulatory guidelines. Clients submit biological samples for mycoplasma detection using various methodologies including PCR and culture-based methods.
- Assay Development and Validation Services: Contract services for developing and validating custom mycoplasma detection assays for client CMC purposes. Includes phase-appropriate validation, analytical method comparability studies, assay transfers, stability studies, custom study design, and regulatory consultancy.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Real-Time PCR Testing (M-1500) |
| Unit Pricing | Pay-as-you-go | Large Volume Barile Method (M-300) |
| Unit Pricing | Pay-as-you-go | Large Volume Barile Method with DNA Fluorochrome (M-350) |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels6 records
Bionique Testing Laboratories product offering
Product offeringCore offering
Bionique Testing Laboratories is a GMP FDA-registered contract research organization that provides mycoplasma testing services for the biopharmaceutical and life science industry. Its core offering includes cell culture testing, raw materials testing, and lot release testing using culture-based methods, real-time PCR assays, and rapid microbial methods, complemented by assay development, validation, and regulatory consultancy for biologics, cell banks, vaccines, and cell and gene therapies.
Product overview
Bionique Testing Laboratories offers a comprehensive portfolio of mycoplasma testing services for the biopharmaceutical industry, operating as a GMP FDA-registered contract research organization with 35+ years of experience. The core service offering includes compendial methods (Harmonized USP <63>, FDA Points to Consider, Ph. Eur. 2.6.7) and rapid molecular methods (Real-Time PCR with Broth Enrichment M-1500) for detection of mycoplasma contamination. Testing services span cell culture testing (M-150, M-250, M-700, M-1400, M-1500), raw materials testing (M-300, M-350), and lot release testing (M-1550), supported by assay development and validation services. The portfolio covers the full product lifecycle for biologics including cell banks, recombinant proteins, gene therapies, cell therapies, vaccines, and in vitro diagnostics. Bionique is a subsidiary of Asahi Kasei Medical's Bioprocess Division.
Differentiator
Problem solved
Functional benefit
Products and services
- Cell Culture Testing GMP-compliant mycoplasma testing for cell lines used in protein production, virus manufacturing, and cellular therapies, including Real-Time PCR with Broth Enrichment (M-1500), Matrix Qualification (M-1500Q), Harmonized USP <63> (M-1400), Inhibition Testing (M-1450), FDA Points to Consider (M-700), Multi-Media Direct Culture with DNA Fluorochrome (M-250), and DNA Fluorochrome Staining Assay (M-150). Targets biotech manufacturers using cell lines for therapeutic production.
- Raw Materials Testing Mycoplasma testing for sera, media, and other bioproducts to detect contamination in incoming raw materials, using the Large Volume Barile Method (M-300), Large Volume Barile Method with DNA Fluorochrome (M-350), and Harmonized USP <63> Test (M-1400). For raw material providers and biomanufacturers screening cell culture media, serum, supplements, and reagents.
- Lot Release Testing Quality control mycoplasma testing for final lot release of vaccines and biologics in accordance with global regulations, including Hybrid Real-Time PCR Phase Appropriate Suitability (M-1550), Inhibition Testing (M-1450), and Multi-Media Direct Culture (M-250). For biopharmaceutical companies producing biologics, biosimilars, and combination products.
- Assay Development, Validation Services and Transfer GMP-registered contract services for developing and validating custom mycoplasma detection assays, including Analytical Method Comparability Studies, Transfer of Assays, Stability Studies, Custom Study Design, and Regulatory Consultancy. Phase-appropriate per FDA, EMA, and ICH guidelines. For biopharmaceutical clients requiring CMC support and method validation.
- In Vitro Diagnostics Testing Support Mycoplasma testing services for in vitro diagnostics to ensure accuracy and freedom from mycoplasma contamination, supporting IVDs involving human cells, genetic testing, metabolic testing, and disease monitoring.
- Vaccines Testing Support Mycoplasma testing services for vaccine production, including live virus, inactivated virus, toxoid, conjugate, and mRNA vaccines, incorporated at multiple points in vaccine production workflow such as cell line seed stocks, cell line passaging, and receipt of new raw materials.
- Gene Therapies Testing Support Mycoplasma testing for gene therapy products, including in vivo and ex vivo delivery methods, supporting viral vectors (AAV), plasmid DNA, and patient-derived cellular gene therapies with rapid, small-volume testing assays.
- Cell Therapies Testing Support Mycoplasma testing for allogeneic, autologous, and multicellular cell therapies, including testing after every new passage and final material testing before patient re-infusion.
- Recombinant Proteins Testing Support Mycoplasma testing services for recombinant protein production, including monoclonal antibodies, divalent fusion proteins, enzymes, and scaffold proteins, supporting cell bank qualification and lot release.
- Cell Banks Testing Support Mycoplasma testing services for Master Cell Bank (MCB), Working Cell Bank (WCB), End of Production Cell Bank (EoPCB), and Research Cell Bank (RCB) qualification, supporting biotech manufacturers from research through GMP-compliant expansion.
Quantifiable outcome
- Time savings of approximately 1 hour (16%) per isolation with automated DNA extraction compared to manual methods
- +2 more outcomes
Companies that use Bionique Testing Laboratories
Customer profileNamed customers3 records
Segments5 records
Ideal customer profiles4 records
Bionique Testing Laboratories technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Bionique Testing Laboratories partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core, major and minor.
- Cellipont BioservicescoreStrategic partnership to advance the adoption and validation of rapid mycoplasma detection methods in support of cGMP manufacturing for cell and gene therapies. Bionique and Cellipont will collaborate to facilitate efficient manufacturing processes.
- Bionova ScientificcoreBionova Scientific, a boutique commercial-scale biologics CDMO, appointed Bionique as the preferred provider for mycoplasma testing services. Both are subsidiaries of Asahi Kasei Corporation's medical division, strengthening the internal partnership network.
- bioMérieuxmajorCollaboration to provide bioMérieux customers direct access to Bionique's product-specific validation services for the BIOFIRE FILMARRAY 2.0 Industry system for mycoplasma detection, facilitating efficient validation and implementation of the technology.
- ThermoFisher ScientificmajorBionique co-presented with ThermoFisher and American Pharmaceutical Review on Key Considerations for Implementing Rapid Microbial Methods for Mycoplasma Detection. ThermoFisher provides the MycoSEQ Real-Time PCR Detection Assay which Bionique has optimized for mycoplasma testing.
- ViruSure GmbHminorViruSure GmbH is another biosafety testing services company under Asahi Kasei Medical's Bioprocess Division. Both companies continue under their existing brands as part of the global biosafety testing services unit.
Scale indicators4 records
Recent moves8 records
Expansion highlights3 records
Bionique Testing Laboratories competitors and assessment
Company assessmentDirect peers
- ViruSure GmbH: Sister company under Asahi Kasei Medical's Bioprocess Division, providing viral and prion safety testing services for biopharmaceuticals. Most direct comparable — both are specialized biosafety testing CROs under the same parent, serving overlapping biopharma clients.
- BioReliance (Merck KGaA): Merck KGaA's biosafety testing services division, providing compendial and rapid microbiological testing (including mycoplasma) for biologics, vaccines, and cell/gene therapies. Directly competes for the same biopharma quality control testing engagements.
- Toxikon Corporation: Preclinical contract testing laboratory providing microbiology, biocompatibility, and analytical testing services for pharmaceutical, medical device, and biotech industries. Direct peer in specialized contract testing for regulated products.
- Pacific BioLabs (PacBio): Contract testing laboratory providing microbiology, analytical, and biosafety testing services for pharmaceutical and biotech clients. Direct peer in specialized microbiology testing for regulated industries.
Broad incumbents
- Charles River Laboratories: Large CRO offering comprehensive biopharmaceutical services including biosafety and mycoplasma testing within its broader manufacturing solutions and microbial testing portfolio. A well-established incumbent with much wider service breadth.
- Eurofins BioPharma Product Testing: Global testing services network providing compendial mycoplasma testing, rapid methods, and biosafety testing for biopharmaceuticals. Operates as a broad incumbent offering testing within a wider contract laboratory portfolio.
- SGS Life Sciences: Global testing, inspection, and certification company providing biosafety and microbiology testing services for biopharma. A broad incumbent offering mycoplasma and related testing within an extensive service portfolio.
- WuXi AppTec: Global CRO/CDMO providing comprehensive testing, manufacturing, and development services for biologics and cell/gene therapies, including biosafety testing. Broad incumbent with deep biopharma relationships, especially in cell and gene therapy.
- Labcorp Drug Development: Major clinical and bioanalytical laboratory offering biopharma testing services including biosafety and microbiology. Operates as a broad incumbent with extensive infrastructure across drug development.
Emerging players
- Sartorius AG: Major bioprocess solutions provider with growing testing services portfolio for cell and gene therapy manufacturing. Emerging player in the rapid testing services space, with overlap in cell therapy and biosafety testing markets.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Bionique Testing Laboratories social profiles
Digital presenceBionique Testing Laboratories compliance and trust
Trust signalCompliance1 record
Bionique Testing Laboratories financial estimates
Financial estimateRevenue estimate
Valuation estimate
Bionique Testing Laboratories leadership team
Management profileNumber of profiles
Profiles5 records
Bionique Testing Laboratories funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Bionique Testing Laboratories M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Bionique Testing Laboratories
What does Bionique Testing Laboratories do?
Bionique Testing Laboratories is a GMP FDA-registered contract research organization that provides mycoplasma testing services for the biopharmaceutical and life science industry. Its core offering includes cell culture testing, raw materials testing, and lot release testing using culture-based methods, real-time PCR assays, and rapid microbial methods, complemented by assay development, validation, and regulatory consultancy for biologics, cell banks, vaccines, and cell and gene therapies.
Is Bionique Testing Laboratories a public or private company?
Bionique Testing Laboratories is a private company. It is classified as corporate owned and is currently operating.
When was Bionique Testing Laboratories founded?
Bionique Testing Laboratories was founded in 1990. It employs 11 to 50 people.
Where is Bionique Testing Laboratories based?
Bionique Testing Laboratories is headquartered in Saranac Lake, United States, in the North America region.
How does Bionique Testing Laboratories make money?
Two revenue lines are on record. Mycoplasma Testing Services are the primary driver. The others are assay Development and Validation Services.
Who are Bionique Testing Laboratories's main competitors?
Direct peers on record are ViruSure GmbH, BioReliance (Merck KGaA), Toxikon Corporation and Pacific BioLabs (PacBio). Broad incumbents are Charles River Laboratories, Eurofins BioPharma Product Testing, SGS Life Sciences, WuXi AppTec and Labcorp Drug Development. Sartorius AG is listed as an emerging player.
Does Bionique Testing Laboratories have an API?
No public API is recorded for Bionique Testing Laboratories.
What industry is Bionique Testing Laboratories in?
Bionique Testing Laboratories's product category is Mycoplasma Testing Services. Its primary akta.pro industry code is HLAAAKAG, Analytical Testing & QC Release Services (potency, purity, sterility), with a secondary code of HLAGADAH, Cell-Based & Potency Assays (Bioassays). Its NAICS code is 541380 and its SIC code is 8734.