ViruSure
ViruSure is an Austrian GMP/GLP-certified CRO providing virus and prion safety testing — viral and prion clearance studies, NGS, TEM, and biosafety consultancy — to biopharmaceutical developers of recombinant products, ATMPs, vaccines, and plasma-derived therapeutics, with over 600 studies completed across 17+ years.
- Company typePrivate
- Founded2005
- HeadquartersVienna, Austria
- Headcount11–50
- GTM typeB2B
- OfferingServices
What ViruSure does
ViruSure is an Austrian Contract Research Organization (CRO) founded in 2005 by Dr. Andy Bailey as a spin-off from the University of Veterinary Medicine Vienna, specializing in virus and prion safety testing for biopharmaceutical products. The company operates from a GMP/GLP-certified facility at the Tech Gate Science and Technology Park in Vienna and has been a wholly owned subsidiary of Asahi Kasei Medical Co., Ltd. since 2019, sitting within its Bioprocess Division alongside sister companies Bionique Testing Laboratories and Bionova Scientific. ViruSure has performed over 600 viral clearance studies across 17+ years and is the only provider of in vivo prion bioassay in Europe — the gold-standard assay for claiming prion safety margins.
The company's service portfolio spans viral clearance studies, prion clearance studies (including the proprietary Western blot assay developed by Dr. Bailey), GMP biosafety studies (in vitro, in vivo, molecular, tumorigenicity/oncogenicity), GMP lot release testing, cell and virus banking, Next-Generation Sequencing using Oxford Nanopore long-read technology (MinION and PromethION), GMP-compliant Transmission Electron Microscopy, and consultancy services covering molecular biology, virus safety strategy, BSE/TSE risk assessments, GMP inspection readiness, cell therapy CMC readiness, and cultured meat innovation. In March 2026, ViruSure and Oxford Nanopore Technologies launched the world's first GMP-validated adventitious viral agent detection test based on long-read sequencing, consolidating multiple legacy assays into a single GMP-compliant workflow.
ViruSure generates revenue through project-based, fee-for-service contracts with biopharmaceutical clients globally, with quote-based pricing that is not publicly disclosed. Customer segments include developers of recombinant products, monoclonal antibodies, Advanced Therapy Medicinal Products (cell and gene therapies), vaccines, plasma- and urine-derived protein products, animal-derived tissue products, and — as an emerging vertical — cell-cultured meat companies. Go-to-market is enterprise field sales with direct engagement, supported by regional representatives in Korea (Young Sciences, Inc.) and Japan (LunaPath), and the company holds PMDA accreditation as a foreign manufacturer to serve Japanese biopharma clients.
ViruSure firmographics
Firmographics- Name
- ViruSure
- Legal name
- ViruSure Forschung und Entwicklung GmbH
- Website
- https://virusure.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- ViruSure is an Austrian GMP/GLP-certified CRO providing virus and prion safety testing — viral and prion clearance studies, NGS, TEM, and biosafety consultancy — to biopharmaceutical developers of recombinant products, ATMPs, vaccines, and plasma-derived therapeutics, with over 600 studies completed across 17+ years.
- Ownership category
- akta.pro rank
ViruSure industry classification
Industry- Product category
- Biosafety Testing Services
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)
- akta.pro secondary industries
- Viral Clearance, Sterile Filtration & Bioburden Control Technologies (HLAAAJAL), Gene Therapy Analytical Testing & QC (potency, vg/ddPCR, infectivity, RCL/RCA) (HLAAACAK), Infectious Disease & Pandemic Preparedness Vaccines (emerging pathogens) (HLAAAEAC)
Keywords
Where ViruSure is headquartered
LocationHeadquarters
- HQ city
- Vienna
- HQ country
- Austria
- HQ region
- Europe
Offices3 records
Markets served
ViruSure business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales
Revenue model
- Contract Research Organization (CRO) Services: ViruSure generates revenue as a CRO providing fee-for-service biosafety testing. Services include viral clearance studies, prion clearance studies, GMP/GLP biosafety studies, cell and virus banking services, molecular testing, TEM, NGS, and consultancy services. Revenue is project-based, typically charged per study or test conducted for biopharmaceutical clients.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
ViruSure product offering
Product offeringCore offering
ViruSure is a Contract Research Organization (CRO) that performs GLP/GMP-compliant biosafety testing services for biopharmaceutical manufacturers. Its core service portfolio covers viral clearance studies, prion clearance studies, GMP biosafety studies (in vitro, in vivo, molecular, TEM, tumorigenicity, lot release), next-generation sequencing, transmission electron microscopy, cell and virus banking, and a range of regulatory consultancies. Services target manufacturers of recombinant products, vaccines, ATMPs, plasma/urine-derived proteins, animal-derived tissue products, and cell-cultured meat.
Product overview
ViruSure is a Contract Research Organization (CRO) providing biosafety testing services as a single unified offering rather than a software platform. The core portfolio consists of testing services organized around viral and prion safety, including Viral Clearance Studies (600+ successful studies), Prion Clearance Studies (including the only in vivo prion bioassay in Europe), GMP Biosafety Studies (in vitro, in vivo, molecular, TEM), and GMP/GLP Characterization (genetic stability, neutralization studies, biodistribution). Supporting services include Next-Generation Sequencing using Oxford Nanopore technology, Transmission Electron Microscopy, Cell and Virus Banking Services, and consultancies covering Molecular Biology, Virus Safety, BSE Expertise, Inspection Readiness, Cell Therapy CMC Readiness, and Cultured Meat Innovation. The company also launched the first GMP-validated adventitious viral agent (AVA) detection test based on Oxford Nanopore sequencing in March 2026. Testing services cover recombinant products, plasma/urine-derived proteins, vaccines, ATMPs (gene/cell therapy), animal-derived products, and cell-cultured meat products.
Differentiator
Problem solved
Functional benefit
Products and services
- GMP-Validated AVA Detection Test (Oxford Nanopore Sequencing) First-in-class GMP-validated adventitious viral agent (AVA) detection test based on Oxford Nanopore long-read sequencing for biopharmaceutical quality control. Consolidates multiple assays into a single test, reducing testing timelines by weeks and simplifying GMP-regulated laboratory workflows while reducing false positives that can trigger costly manufacturing pauses.
- Viral Clearance Studies GLP and non-GLP viral clearance studies evaluating a biopharmaceutical product's manufacturing process ability to remove or inactivate viral agents, essential prior to clinical trials. Includes consultancy on study design. Over 600 successful studies performed across a wide range of biopharmaceutical products.
- Prion Clearance Studies Investigational prion safety studies including the only in vivo prion bioassay available in Europe - the gold standard for claiming prion safety margins. Services include TSE model studies, Western blot testing for prion protein (first commercially available), and in vivo prion bioassays using rodent-adapted prion strains.
- GMP Biosafety Studies GMP-compliant biosafety testing including in vitro safety studies, molecular tests, transmission electron microscopy, in vivo safety studies, tumorigenicity and oncogenicity studies, and GMP lot release testing for bulk harvests.
- Next-Generation Sequencing (NGS) GMP-compliant NGS testing for genetic characterization (genetic stability, sequence identity, cell line identity) and adventitious agent detection using Oxford Nanopore long-read sequencing technology with MinION and PromethION devices, achieving over 99% accuracy.
- Transmission Electron Microscopy (TEM) GMP-compliant TEM testing for adventitious agents, RVLPs, virus characterization, and AAV analysis using negative stain TEM, positive stain TEM, and cryoTEM techniques. Includes determination of capsid particle population, assessment of capsid integrity and purity, and distinguishing between full-empty capsid ratios, with low sample requirements (2 µL, 1×10^11 vp/mL).
- Cell and Virus Banking Services GMP cell and virus banking services including characterization, storage, and sterility and mycoplasma testing for biopharmaceutical production.
- GMP/GLP Characterization Characterization studies including genetic stability testing, neutralization studies, virus permissivity studies, and biodistribution studies for ATMPs.
- Molecular Biology Consultancy Expert consultancy for molecular biology applications, experiment design, and data interpretation using NGS, qPCR, dPCR, and Sanger sequencing technologies.
- Virus Safety Consultancy Comprehensive virus safety strategy development including donor testing, process evaluation for virus removal, virus validation for continuous manufacturing, and regulatory guidance.
- BSE/TSE Risk Assessment Consultancy Expert consultancy for BSE and TSE risk management including biosafety evaluation, CTD 3.2.A.2 documentation, epidemiology assessment, prion clearance capacity evaluation, and prion safety assessments.
- Inspection Readiness Consultancy GMP inspection readiness consultancy including mock inspections, gap analysis, sterility assurance, and contamination control strategy development aligned with GMP Annex 1 requirements.
- Cell Therapy CMC Readiness Consultancy Consultancy for cell therapy Chemistry, Manufacturing, and Controls readiness including mycoplasma testing guidance, regulatory navigation, virus clearance study design for AAVs, and virus safety risk assessments.
- Cultured Meat Innovation Consultancy Specialized consultancy for cultured meat products including cell culture optimization, donor animal risk assessments, TSE risk assessments, sterility testing, and mycoplasma testing.
- Disinfectant Testing Virucidal efficacy testing of disinfectants following DIN, Robert Koch Institute (RKI), and German Association for the Control of Virus Diseases (DVV) guidelines.
Quantifiable outcome
- First GMP-validated adventitious viral agent detection test based on Oxford Nanopore sequencing consolidates multiple assays into a single test, potentially reducing testing timelines by weeks
- +1 more outcomes
Companies that use ViruSure
Customer profileNamed customers6 records
Segments6 records
Ideal customer profiles5 records
ViruSure technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
ViruSure partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- Oxford Nanopore TechnologiescoreViruSure collaborated with Oxford Nanopore Technologies to launch the world's first GMP-validated adventitious viral agent (AVA) detection test based on Oxford Nanopore sequencing for biopharmaceutical quality control. The solution consolidates multiple assays into a single test, reducing testing timelines and simplifying GMP-regulated workflows. ViruSure is an Oxford Nanopore certified service provider, operating MinION and high-throughput PromethION devices. The partnership progressed from GLP validation in August 2025 to GMP validation, demonstrating regulatory readiness for commercial biologics manufacturing.
- neotem BioanalyticscoreViruSure partnered with neotem Bioanalytics, a specialist in GMP-compliant electron microscopy analysis with over 40 years of combined experience in electron microscopy, virology, and quality assurance. The collaboration addresses bottlenecks for high-quality and rapid TEM analysis, enabling improved timelines for pathogen safety testing. neotem provides GMP-compliant TEM analysis for cell banks, virus banks, bulk harvests, and AAV testing, while ViruSure supports neotem in enhancing their quality system to achieve state-of-the-art GMP-compliant services.
- Bionova Scientific, LLCminorBionova Scientific, LLC was acquired by Asahi Kasei Medical and operates as a sister company to ViruSure. Bionova Scientific is a provider of contract process development services and GMP-compliant contract manufacturing services to biopharmaceutical companies. The acquisition represents a strategic complementary addition to strengthen Asahi Kasei Medical's bioprocess business and US market presence.
- Bionique Testing Laboratories LLCcoreBionique Testing Laboratories LLC was acquired by Asahi Kasei Medical and joined ViruSure as a sister company within the global biosafety testing services unit of Asahi Kasei Medical's Bioprocess Division. Bionique specializes in mycoplasma testing services for biologics and life sciences. The acquisition brings together the unique mycoplasma and viral safety proficiencies of both companies, enabling comprehensive biosafety testing support. Both companies continue operations under their existing brands.
Scale indicators4 records
Recent moves8 records
Expansion highlights6 records
ViruSure competitors and assessment
Company assessmentBroad incumbents
- Sartorius (BIA Separations / Analytical Services): Broad bioprocess vendor that has expanded into biosafety and viral clearance services through acquisitions, competing for the same gene-therapy and ATMP safety testing work as ViruSure.
- WuXi AppTec (WuXi Biologics / Testing Division): Global CRO/CDMO with biosafety testing capabilities bundled into a much larger biologics services portfolio; competes on scale and integrated offering rather than specialization.
- SGS (Life Sciences / Health & Nutrition): Global testing, inspection, and certification company offering biosafety, viral clearance, and cell bank characterization as part of a much broader life sciences services portfolio.
Direct peers
- Texcell (Institut für Virusforschung): Specialist virology CRO providing viral clearance studies, biosafety testing, and viral vector characterization — a close niche competitor in virus safety testing for biopharma.
- Charles River Laboratories: Large global CRO with a Biologics Testing Solutions segment that provides viral clearance, biosafety, and cell banking services for biopharmaceutical clients — directly overlapping ViruSure's core offering.
- Nelson Labs (Sotera Health): Provides GMP/GLP laboratory testing including viral clearance, biocompatibility, and extractables/leachables, with significant overlap to ViruSure's biosafety testing portfolio.
- Eurofins Scientific (BioPharma Product Testing): Global CRO offering biosafety, viral clearance, and cell bank characterization services across multiple continents; competes for the same biopharma safety-testing RFPs as ViruSure.
- Bionique Testing Laboratories: Sister company under Asahi Kasei Medical specializing in mycoplasma testing for biologics; provides overlapping biosafety testing services to the same client base as ViruSure.
- BioReliance (Merck/Sigma-Aldrich Biopharma Services): Provides biosafety testing, viral clearance, and raw material testing for biologics and gene therapies under Merck's Life Science Services arm, overlapping heavily with ViruSure.
Emerging players
- Vironova (part of BioTek Labs): Specialist in transmission electron microscopy for viral vectors and gene therapy products — overlapping with ViruSure's GMP TEM and AAV characterization services.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks5 records
Key highlights6 records
Customer concentration
ViruSure social profiles
Digital presenceViruSure compliance and trust
Trust signalCompliance6 records
ViruSure financial estimates
Financial estimateRevenue estimate
Valuation estimate
ViruSure leadership team
Management profileNumber of profiles
Profiles8 records
ViruSure funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ViruSure 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 ViruSure
What does ViruSure do?
ViruSure is a Contract Research Organization (CRO) that performs GLP/GMP-compliant biosafety testing services for biopharmaceutical manufacturers. Its core service portfolio covers viral clearance studies, prion clearance studies, GMP biosafety studies (in vitro, in vivo, molecular, TEM, tumorigenicity, lot release), next-generation sequencing, transmission electron microscopy, cell and virus banking, and a range of regulatory consultancies. Services target manufacturers of recombinant products, vaccines, ATMPs, plasma/urine-derived proteins, animal-derived tissue products, and cell-cultured meat.
Is ViruSure a public or private company?
ViruSure is a private company. It is classified as corporate owned and is currently operating.
When was ViruSure founded?
ViruSure was founded in 2005. It employs 11 to 50 people.
Where is ViruSure based?
ViruSure is headquartered in Vienna, Austria, in the Europe region.
How does ViruSure make money?
One revenue line is on record: contract Research Organization (CRO) Services.
Who are ViruSure's main competitors?
Broad incumbents on record are Sartorius (BIA Separations / Analytical Services), WuXi AppTec (WuXi Biologics / Testing Division) and SGS (Life Sciences / Health & Nutrition). Direct peers are Texcell (Institut für Virusforschung), Charles River Laboratories, Nelson Labs (Sotera Health), Eurofins Scientific (BioPharma Product Testing), Bionique Testing Laboratories and BioReliance (Merck/Sigma-Aldrich Biopharma Services). Vironova (part of BioTek Labs) is listed as an emerging player.
Does ViruSure have an API?
No public API is recorded for ViruSure.
What industry is ViruSure in?
ViruSure's product category is Biosafety Testing Services. Its primary akta.pro industry code is HLAGAAAC, Toxicology & Safety Assessment CROs (GLP), with a secondary code of HLAAAJAL, Viral Clearance, Sterile Filtration & Bioburden Control Technologies. Its NAICS code is 541714 and its SIC code is 8731.