When your protein demands uncompromising quality, your manufacturing partner must deliver it.
You can rely on 53Biologics for GMP manufacturing of mammalian cell-derived APIs, like antibodies, mAbs, biosimilars or growth factors.
From process robustness to batch-to-batch consistency, we help you move confidently toward preclinical, clinical and commercial supply.
Line 1 – Up to 200 L
Single-use 200 L bioreactor with fully integrated single-use downstream, including filtration, scalable chromatography, viral clearance or UF/DF, supporting robust clinical manufacturing and seamless scale-up to commercial production for drug subtances and drug products.
Line 2 – Up to 2000 L
GMP Manufacturing line with a single-use 2000 L bioreactor with end-to-end single-use downstream capabilities, including filtration, scalable chromatography, viral clearance or UF/DF, enabling reliable clinical and commercial manufacturing of drug substance and drug product with full process continuity.
Alongside drug substance production, we offer integrated drug product manufacturing services, including aseptic fill & finish for clinical supply. Our capabilities support a seamless transition from bulk drug substance to ready-to-use drug product.
Discover how our fill & finish capabilities can support your clinical programs.
One-Stop-Shop Solution
End-to-end drug substance and drug product services with a single partner, minimizing transfer risks.
Flexible Scales
GMP manufacturing scales of 200 L and 2000 L with single-use DSP equipment associated.
Track Record
mAbs, ADCs, biosimilars, Fc-fusion proteins, nanobodies, cytokines, growth factors, VLPs and more.
Fast Track Supply
From gene to Drug Substance in just 12 months for expedited project timelines.
GMP and GMP-like Available
We can perform GMP-like under ISO 13485, and full GMP in accordance with EU GMP.
Customized Solutions
Each project is unique, and so are our proposals. We tailor every offer to your needs.
We Care About You
We work closely with you to ensure your success, because when you succeed, we succeed.
Biologics At The Core
As a CDMO specialized in biologics, protein manufacturing is part of our expertise in bioprocesses.
We know that your project still needs a high degree of quality to ensure process and product consistency even when GMP compliance is not demanded.
We count with single-use bioreactors from 20 L to 50 L and its associated single-use DSP.
Discover more about our CDMO protein services
We would love to hear from you!
Please note that job applications submitted through this form will not be considered. Use the Careers page.
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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