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Mammalian Manufacturing Services
When your protein demands uncompromising quality, your manufacturing partner must deliver it. You can rely on 53Biologics to produce mammalian cell-derived APIs, like mAbs, fusion proteins or enzymes.
Manufacturing turns a validated mammalian process into GMP and non-GMP batches across the scale your program needs.
This service is available also for:
Overview
Together, Supporting Your Mammalian Needs
We are your trusted partner for mammalian protein manufacturing, supporting projects from early development to clinical and commercial supply.
Our experience with CHO and HEK293 expression systems allows us to produce complex recombinant proteins such us monoclonal antibodies, biosimilars or cytokines. These proteins require proper folding, glycosylation and other critical post-translational modifications to ensure efficacy and safety.
Combined with integrated process development, GMP manufacturing and analytical capabilities under one roof, we help reduce technical risk, simplify technology transfer and accelerate your path to the clinic and the market.
Capacities for Mammalian Protein Production
Non-GMP Line
USP: from 20L to 50 L stainless steel bioreactors
DSP: centrifuge, TFF, chromatography
Perfect for early stage or scale-up needs
GMP Line
USP: up to 2000 L single-use bioreactors
DSP: depth filtration, ultrafiltration/diafiltration and single-use chromatography (i.e. protein A)
Able to handle demands of complex and high-volume productions
Process
Our Protein Manufacturing Process
01
Cell Line & Inoculum Preparation
Expansion of the production cell line from Master/Working Cell Bank (MCB/WCB) to generate a healthy, reproducible inoculum for manufacturing.
02
Cell
Culture
Controlled cultivation of mammalian cells in single-use bioreactors to express the recombinant protein under optimized process conditions.
03
Harvest and Clarification
Separation of cells and particulates from the culture supernatant through centrifugation and/or depth filtration to recover the target protein.
04
Downstream and Viral Clearance
Product capture, viral inactivation and/or removal, polishing and concentration using chromatography and filtration technologies to achieve the required purity and quality attributes.
05
Fill &
Finish
Aseptic filling lyophilization (when required), and packaging of the final drug product into vials, bottles, or single-use bags under GMP conditions.
06
Quality Control & Batch Release
Comprehensive analytical testing of in-process samples and final DS/DP to ensure compliance with predefined specifications.
Technical Specifications
Mammalian Capabilities Designed to Support Every Stage of Protein Manufacturing
Human-Like Post-Translational Modifications
Access to CHO and HEK293 expression platforms through qualified partners for proteins requiring complex folding and glycosylation.
Clinical or Commercial Drug Substance Supply
Drug Substance manufacturing using up to 2,000 L single-use bioreactors, combined with single-use filtration and chromatography systems,.supporting programs from clinical development to commercial supply.
Integrated Drug Product Manufacturing
Aseptic Fill & Finish supported by Grade A isolator and SciLog technologies for the filling of vials, bottles and single-use bags. Plus integrated lyophilization for liquid and freeze-dried products.
End-to-End Project Execution
Integrated process development, analytical services, GMP manufacturing, Fill & Finish and technology transfer managed by one multidisciplinary team.
Long-Term Material Storage
Controlled GMP storage from −80 °C to room temperature for Drug Substance, Drug Product and retained samples and liquid nitrogen for cell banks.
Regulatory-Ready Manufacturing
EMA-inspected facilities supported by ISO 9001, ISO 13485 and GMP certifications with Quality Management System aligned with ICH guidelines and 21 CFR Eudralex.
Why Choose 53Biologics for Mammalian Protein Manufacturing
Close Collaboration at Every Stage
Work directly with the scientists responsible for your mammalian program. Close communication keeps cell culture, purification, analytical and manufacturing decisions aligned with your molecule, quality requirements and development priorities.
Expertise for Complex Molecules
Our team applies scientific expertise across mammalian cell culture, downstream purification, viral clearance and analytical control. This integrated understanding helps address productivity, product quality and process robustness challenges with data-driven decisions.
A Process Built Around Your Protein
The manufacturing strategy is adapted to your cell line, molecule, batch requirements and program stage. Flexible single-use operations and tailored process parameters help maintain momentum when technical needs or priorities change.
Continuity as Your Program Advances
Keep process development, GMP manufacturing, analytical testing and Fill & Finish connected with one CDMO. Retaining process knowledge within the same team reduces transfer risk and supports smoother progression toward clinical and commercial supply.
Support
Frequently Asked Questions
Common questions about our mammalian protein manufacturing services. Can’t find what you need? Talk to our team.
What mammalian protein manufacturing services does 53Biologics offer?
53Biologics supports mammalian protein manufacturing for recombinant proteins and complex biologics, from process transfer and scale-up to GMP or GMP-like production. Our team works closely with each client to adapt the manufacturing strategy to the molecule, development stage and regulatory pathway.
Which mammalian expression systems can you work with?
We work with mammalian cell culture platforms commonly used for biologics development and manufacturing, including CHO-based systems. Our team can support transferred processes or help optimise upstream and downstream workflows where additional development is required before manufacturing.
Can you manufacture mammalian proteins under GMP?
Yes. 53Biologics can support mammalian protein manufacturing under GMP-like quality standards or full GMP conditions, depending on the project requirements. This allows clients to align production with preclinical, clinical or regulated supply needs.
How does 53Biologics help reduce risk during manufacturing?
We combine scientific expertise, proactive communication and hands-on project ownership to identify technical risks early and keep programs moving. In addition, our integrated capabilities in process development, manufacturing, analytics and Fill & Finish help reduce handoffs and improve continuity across the project.
Talk With an Expert About Your Mammalian Manufacturing Project
Tell us about your molecule, quality grade and target scale — our team will get back to you as soon as possible.
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