We are a reliable and flexible CDMO specialized in the clinical manufacturing of biotherapeutics. We offer a comprehensive range of services to support our clients in developing and manufacturing their innovative therapies.
At 53Biologics we are experts in biotherapeutics and proteins production. Our scientific team creates tailor-made projects combining our expertise with the most advanced technologies. As a customer-focused CDMO, our protein services are fully adapted to our clients requirements in terms of time and quality.
Cell Line Development
Cell Banking Services
Process Development
Protein Manufacturing
Analytical Services
Quick turnaround times for your biotherapeutics production
At 53Biologics, we understand the critical role a reliable production strain plays in the development of your biotherapeutic candidate. That’s why we offer comprehensive microbial strain development services based on our extensive experience in the field.
Our expert team can handle every step of the process to the creation of a stable and fully characterized Master Cell Bank (MCB). With complete documentation of all materials used and full traceability of every operation performed, you can rest assured that your project will meet all regulatory requirements.
At 53Biologics, we prioritize the creation of tailored solutions for each unique molecule. Our expert team leverages their extensive know-how to solve challenging issues on tight timelines, and we are dedicated to providing the best possible outcomes for every project we undertake. Whether your project falls under well-established standards or requires a more customized approach, we are ready to take on any protein process development challenge.
At 53Biologics, we provide comprehensive CDMO services from strain development to cGMP production of both drug substance and drug product. We are experts in microbial processes using various strain lines such as E. coli, P. pastoris and fungal platforms. By partnering with us, you can trust that we will help you achieve success in the development of your biotherapeutic candidate.
Our experienced team boasts in-house analytical QC capabilities and seasoned QA experts, ensuring consistent, high-quality services with every project. As a CDMO, we specialize in the manufacture of recombinant proteins using microbial expression systems, and we prioritize the utmost care and attention to quality in all stages of production. Our commitment to excellence ensures that we deliver products that meet the highest standards of quality and efficacy.
At 53Biologics we have experience working on the production of a wide range of biotherapeuctics and proteins like antibodies, biosimilars, enzymes, anticoagulants.
