From cell line development to aseptic Fill & Finish
At 53Biologics, we cover every stage from early development to GMP production. Leveraging platforms such as CHO and HEK293, we adapt to your specific project needs, ensuring speed, quality, and regulatory compliance. With integrated process development, manufacturing, and aseptic Fill & Finish, we offer a true end-to-end CDMO solution for your biologics.
From first expression to clinical supply: robust cell line selection (CHO/HEK293), data-driven upstream and downstream development, stage-appropriate analytics, and GMP-ready single-use unit operations. The result is faster tech transfer, reliable scale-up, and batch-to-batch consistency that keeps your program on track for regulatory milestones.
Flexible platforms (CHO, HEK293 and others) with partners, stable and transient expression, GMP & non-GMP cell bank generation and characterization.
Upstream (rocket motion, single-use bioreactors,...) and downstream (chromatography, TFF, viral inactivation) optimization to increase yields and reduce costs.
GMP mammalian lines (up to 200L) and nonGMP line (up to 50L), single-use DSP, robust quality control. Crosscontamination mitigation due to segregated distribution and flows.
Aseptic filling in a Grade A isolator with true flexibility in dosage forms and formats. Able to fill vials (2R to 30R), bottles (100 mL to 20L) and single use bags (250 mL to 200L). Labeling, packaging, batch release and GMP storage also available.
Multiple mammalian cell hosts to select the most promising one for your concrete project.
Cell line development (with trusted partners for CHO, HEK293 and othersw), cell banking generation and characterization under ICH guidelines, process/analytical development, and GMP manufacturing.
More than 15 GMP batches/year for the production of monoclonal antibodies, biosimilars, Fc-fusions/nanobodies, cytokines, growth factors, VLPs and more.
Operations aligned with FDA/EMA expectations and international standards (GMP, GLP, GCP; ISO 9001, 13485, 14001).
Projects start within less than a month since the contract signature
Our state-of-the-art GMP facilities are designed to ensure safe, compliant and efficient mammalian protein production. With dedicated segregated areas for microbial and mammalian platforms, we minimize cross-contamination risks.
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53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provide services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.
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