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.
Single-use 200 L bioreactor
Single-use 200 L bioreactor supporting robust clinical manufacturing and seamless scale-up to commercial production for drug subtances and drug products.
Single-use 2000 L bioreactor
GMP Manufacturing line with a single-use 2000 L bioreactor enabling reliable clinical and commercial manufacturing of drug substance and drug product with full process continuity.
End-to-end single-use downstream capabilities
Fully integrated single-use downstream, including filtration, scalable chromatography, viral clearance and UF/DF.
Alongside drug substance production, we offer integrated drug product manufacturing services, including aseptic fill & finish for clinical and commercial supply. Our capabilities support a seamless transition from bulk drug substance to ready-to-use drug product.
Adaptable Capabilities
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.
Production under Different Quality Standards
We can perform GMP-like under ISO 13485, and full GMP in accordance with EU GMP.
Quick Turnaound
Swift project iniciation thanks to our skilled team and proactivity in tech transfer, ER and validation batches.
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.
20-50 L
with associated single-use DSP
Discover more about our CDMO protein services
We would love to hear from you!
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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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