Biotactical B.V.

Biotactical B.V. is a Dutch biotech company that has developed a proprietary rapid microbial sterility testing platform based on ATP bioluminescence, reducing standard sterility testing time from 14 days to 48 hours. Our technology is particularly suited for Advanced Therapy Medicinal Products (ATMPs), including Cell & Gene therapies, where conventional sterility testing timelines are incompatible with the short shelf life of living cellular products.

Biotactical’s ATP bioluminescence-based rapid sterility testing platform fundamentally transforms microbial quality control in biopharmaceutical manufacturing. Key technological strengths include:

• Speed: Delivers confirmed sterility results within 48 hours, versus the compendial 14-day incubation period (USP <71>, EP 2.6.1), enabling faster product release and reducing batch hold times.
• ATMP Compatibility: Validated specifically for Cell & Gene therapy products, including CAR-T cells and viral vectors, where conventional testing timelines exceed product shelf life.
• Regulatory Alignment: Methodology developed in compliance with USP <1223>, ICH Q2(R1), and GMP frameworks, positioning it as a validated analytical release testing method suitable for regulatory submissions.
• Proprietary Growth Media: Our optimized oTSB formulation enhances microbial recovery while mitigating interference from product excipients such as DMSO, commonly present in ATMP products.
• Broad Applicability: Platform is applicable across sterile injectables, biologics, ATMPs, and other sterile pharmaceutical products, making it highly versatile for the Chinese biopharma market.