Protein Production Services

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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.

Experts in Biotherapeutics Production

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. 

Discover more about 53Biologics Services for Proteins & Biotherapeutics

Cell Line Development

We have wide experience in E.coli, P. pastoris and fungal strain development and mammalian cell line development for the manufacturing of your biologic.
cell banking

Cell Banking Services

We are fully capable to produce and characterize Master Cell Banks (MCB) and Working Cell Banks (WCB) in our GMP compliant suits.

Process Development

Experts in Upstream and Downstream Development and the generation of robust and reproducible production processes.

Protein Manufacturing

In our GMP area we can produce your biotherapeutics, monoclonal antibodies, biosimilars and vaccines meeting your requirements and needs in time.

Analytical Services

We can implement, develop, validate and transfer a full quality control (QC) package for your recombinant protein, even complying with GMP requirements.

Quick turnaround times for your biotherapeutics production

Expert Team for Microbial Manufacturing

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.

GMP Cell Banking Services

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.

The Process Development Services that You Need

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.

Experts in Protein Manufacturing of Microbial-based Biotherapeutics

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.

Ensuring High-Quality Services

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.

If you would like to learn more about our services, please Contact Us!

At 53Biologics we have experience working on the production of a wide range of biotherapeuctics and proteins like antibodies, biosimilars, enzymes, anticoagulants.