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CDMO Services for Proteins
We deliver end-to-end protein production for preclinical, clinical and commercial supply. With flexibility and our proactive approach, we reduce complexity and accelerate every step from development to fill and finish.
Select Your Production System
Choose your production system. The services, host organisms and capacity shown below update to match your selection.
Microbial
E. coli · Pichia pastoris · Filamentous fungi · Bacillus
Mammalian
Partner-supported CLD · CHO · HEK
≤ 2000L
Fermentation capacity for microbial and mammalian
4
Manufacturing lines available
10+
Years of hands-on experience in biomanufacturing
150+
Documented projects already executed
Process
One-Stop-Shop for Protein Production
Host Systems
E. coli
Pichia pastoris
Filamentous fungi
Bacillus
Host Systems
Partner-supported CLD
CHO
HEK293
↑ Microbial — matches your selection
Microbial Protein Services
Microbial Strain Development
Experience with E. coli and P. pastoris but also many other microbial strains like Bacillus and fungal expression systems. Trust in our ability to develop high-yielding production strains whether you need fast prototyping, yield improving or complex protein expression.
Microbial Strain Development
Microbial Cell Banking
A fully integrated solution for your microbial cell banking needs. Master Cell Bank (MCB) and Working Cell Bank (WCB) generation, characterization, long-term storage and release. Our team works with you through all stages of cell bank manufacturing.
Microbial Cell Banking
Microbial Process Development
Our team combines deep expertise in upstream and downstream to tackle common challenges such as low expression, inclusion bodies and downstream bottlenecks. Our flexible operation structure is specifically designed to adapt process development to the characteristics of your protein and expression system.
Microbial Process Development
Microbial Protein Manufacturing
Scale microbial protein production from preclinical needs to clinical and commercial supply whether your needs are GMP or non-GMP. At 53Biologics we combine 200L and 2000L GMP microbial capacity with non-GMP production up to 500L, allowing you to choose the quality level that matches your program stage.
Microbial Protein Manufacturing
Analytical Support
Integrated analytical services across raw materials testing, in-process control, release and stability studies. More than 90 already validated analytical methods help reduce outsourcing, shorten feedback loops and keep analytical data connected to manufacturing decisions.
Analytical Support
Fill & Finish
We offer fill & finish solutions across a range of fill volumes and container formats to meet the specific requirements of your product and application. This flexible approach allows us to support all types of projects ensuring the right configuration for your manufacturing needs.
Fill & Finish↑ Mammalian — matches your selection
Mammalian Protein Services
Mammalian Cell Line Development
Build a mammalian cell line in CHO, HEK or other suitable mammalian platforms with support from our recognized cell line development partners. We define the optimal host and strategy based on your protein and future manufacturing needs.
Mammalian Cell Line Development
Mammalian Cell Banking
Build a mammalian cell line in CHO, HEK or other suitable mammalian platforms with support from our recognized cell line development partners. We define the optimal host and strategy based on your protein and future manufacturing needs.
Mammalian Cell Banking
Mammalian Process Development
Optimize mammalian upstream and downstream operations to balance yield, cost, robustness, operability and scalability. Our team works with single-use bioreactors, depth filtration, chromatography and viral inactivation strategies to build a process ready for scale-up and GMP transfer.
Mammalian Process Development
Mammalian Protein Manufacturing
Produce mammalian cell-derived APIs in our single-use GMP facilities designed for safe, compliant biologics manufacturing. 53Biologics supports GMP production up to 2000L and non-GMP work up to 50L for antibodies, biosimilars, fusion proteins and other mammalian proteins.
Mammalian Protein Manufacturing Analytical Support
Integrated analytical services across raw materials testing, in-process control, release and stability studies. More than 90 already validated analytical methods help reduce outsourcing, shorten feedback loops and keep analytical data connected to manufacturing decisions.
Analytical Support Fill & Finish
We offer fill & finish solutions across a range of fill volumes and container formats to meet the specific requirements of your product and application. This flexible approach allows us to support all types of projects ensuring the right configuration for your manufacturing needs.
Fill & FinishManufacturing Built Around Your Programme
From early development to GMP manufacturing, we align the production environment, quality framework and manufacturing approach with the needs of your protein programme.
Microbial
Mammalian
GMP Capacity
Operations under GMP or ISO 13485
USP: up to 2000L
DSP: Standard with aseptic Fill & Finish
USP: up to 2000L
DSP: Single-use with aseptic Fill & Finish
Non-GMP Capacity
Operations under ISO 9001
USP: up to 500L
DSP: Standard
USP: up to 50L
DSP: Single-use
Why Choose 53Biologics for Protein Production
Working Side-by-side
53Biologics keeps you close to the people shaping your protein program so you stay connected to the detail and the decisions around it. Thanks to direct scientist-to-client engagement, we remove the barriers that typically sit between your program and its progress.
Scientific Depth You Can Rely On
We bring hands-on experience across the entire drug development journey that helps turn data into clear next steps. The result is clarity at key decision points, with more confidence in the choices shaping your program.
Flexible Approach
Biologics programs evolve as priorities shift, data develops and new needs emerge along the way. 53Biologics shapes the scope of work to fit your program, helping you find the right path forward without forcing the work into a rigid process.
We Succeed When You Do
You need a partner who treats your success as their own, not just a set of tasks to complete. 53Biologics does just that, sharing ownership of the outcome and staying engaged from the first decision to final delivery.
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