HUMAN
THERAPEUTICS
We provide bacteriophage production for human therapeutics, providing best in class quality solutions for preclinical research, clinical trials and personalized therapy. Our expertise ensures safe, effective and scalable production while meeting strict regulatory standards.
END-TO-END SOLUTIONS
From phage discovery to GMP clinical trial material.
SCALABLE PRODUCTION
Flexible manufacturing capabilities, ranging from small to large scale, with batch sizes up to 200 L and a weekly capacity of 600 L.
ADVANCED PROCESS DEVELOPMENT
Optimized upstream and downstream techniques, achieving average yield improvements of up to 10-folds.
STABILITY TESTING
Ensuring product integrity and consistency
COMPREHENSIVE QUALITY CONTROL
In-process analytics, release testing and stability assessments to meet high-quality standards.
CELL BANKING & STORAGE
Secure preservation of bacterial and phage strains with 24/7 monitoring. All critical materials are stored at two separate locations.
ANIMAL-FREE (TSA/BSE FREE) MANUFACTURING
Use of biopharmaceutical-grade raw materials, including animal-free origin.
REGULATORY SUPPORT
Comprehensive documentation and compliance guidance, ensuring a fully compliant CMC package for regulatory submissions and clinical trial applications.
R&D / Pre-clinicaL
We offer high-quality bacteriophage products for R&D and preclinical applications (human therapeutics), from small to large scale, ensuring reliability, purity and consistency to support diverse research and clinical needs.
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Comprehensive phage characterization, including a Certificate of Analysis (CoA) upon request.
Genomic sequencing of bacteriophages and production hosts, assessing classification, prophages, virulence factors, antibiotic resistance genes and transducing ability.
Phage amplification and purification to ensure high-quality production.
Customized phage formulations, including Fill & Finish services.
Phage and host banking & secure storage for long-term preservation.
Personalized therapy
We offer high-quality bacteriophage products for personalized therapy, providing customized solutions that ensure effective treatment and consistent quality to meet each patient's specific needs.
Phage selection, screening and characterization, including a Certificate of Analysis (CoA) or Phage Passport.
Personalized phage discovery tailored to specific needs.
Customized GMP and non-GMP phage production to meet regulatory and research requirements.
Comprehensive quality control and assurance to ensure product integrity.
Regulatory support and compliance for seamless approval processes.
GMP - Clinical Trial Material
We provide high-quality bacteriophage products for clinical trial materials, ensuring reliable, consistent, and GMP-compliant phage production to support safe and effective clinical testing.
GMP-compliant phage selection and characterization, accompanied by a Certificate of Analysis (CoA)
GMP-grade phage production for Active Pharmaceutical Ingredient (API), Drug Substance (DS), and Drug Product (DP)
Validated analytical methods to ensure consistency and meet regulatory requirements
Fill & Finish services, including compliant labeling and packaging
GMP/ICH-compliant stability studies and QA oversight, with QP batch release to support regulatory approval
