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Microbial Process Development
Transform laboratory-scale expression into a reproducible manufacturing process. 53Biologics develops microbial upstream and downstream processes that maximize productivity, simplify scale-up and support successful GMP manufacturing.
Process development turns a working strain into a robust, scalable process ready for GMP manufacturing.
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Strain Development
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Cell Banking
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Process Development
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Analytical Support
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Manufacturing
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Fill & Finish
This service is available also for:
Overview
Upstream Process Development Built Around Your Microbial Host
We build processes with you. Whether starting from scratch or improving an existing fermentation, our scientists work closely with your team to define the right strategy for your protein, host and manufacturing goals.
Drawing on our experience across diverse microbial expression systems, we investigate the key parameters that drive cell growth, protein expression and process consistency. We then test multiple process conditions in parallel, enabling us to efficiently compare different approaches and rapidly identify optimal conditions. Fermentation studies at scales ranging from 1 L to 30 L provide actionable data that guide further process refinement as results emerge. Ultimately, this iterative and data-driven approach enables us to develop robust upstream processes that are ready for technology transfer and reliable production.
Downstream Development Strategies to Solve Your Purification Problems
Solubility, expression compartment, product stability and impurity profiles all shape the downstream strategy. We adapt to your protein. Our scientists work closely with your team to understand these variables and design a purification process aligned with your product characteristics.
We develop downstream processes for soluble and insoluble proteins expressed in the cytoplasm, periplasm or inclusion bodies. We optimise each step. From harvest and cell disruption to clarification, concentration and final purification, every unit operation is selected to balance recovery, purity, robustness and scalability.
Our infrastructure includes centrifugation, cell rupturing and tangential flow filtration using different membranes, alongside ÄKTA chromatography equipment. These capabilities allow us to deliver integrated processes ready for scale-up and regular production.
Build, Optimise and Scale Your Microbial Process
Development
Build an integrated production process around your microbial host and protein. We develop and optimise fermentation conditions and purification strategies to improve productivity, recovery, purity, product quality and overall process robustness.
Optimization
Improve an existing upstream or downstream process by identifying the parameters and unit operations limiting performance. Our scientists use structured experimentation and data-driven decisions to increase yield, robustness, scalability and operational efficiency.
Scale-Up
Translate laboratory processes into manufacturing-ready operations while protecting process performance and product quality. Development in representative equipment and at progressively larger scales supports a smoother transfer into non-GMP or GMP production
Process
What We Do During Process Development
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Project
Definition
We define the development strategy based on your starting point, whether optimizing an existing process or developing a new one from scratch, establishing the target product profile, manufacturing goals and critical success criteria.
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Upstream Process Development
A structured series of small-scale fermentation batches is performed to optimize expression conditions, including media composition, feeding strategy, induction parameters and cultivation time, generating material for downstream development.
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Downstream Process Development
The downstream process is optimized step by step. Each filtration or chromatography step is individually developed and fixed before subsequent steps are optimized, resulting in a robust, scalable purification process that meets the target quality attributes.
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Confrimation
Run
The optimized upstream and downstream processes are executed as an integrated workflow at representative scale to verify overall process performance, robustness and readiness for scale up or GMP manufacturing.
Why Choose 53Biologics for Process Development
Real
Collaboration
We work side by side with your team to adapt the development plan to your molecule, host, existing data and manufacturing goals. The scope evolves around what your program actually needs.
Scientific Depth at Every Decision
Direct access to upstream and downstream scientists helps turn experimental data into clear, technically grounded decisions. We address expression, purification, recovery and robustness challenges with the next development stage in mind.
Adaptability That Maintains Momentum
Parallel studies and flexible development strategies allow us to respond quickly as new results emerge. This helps avoid rigid workflows, address bottlenecks early and keep the program moving.
One Partner from Development to Scale
We develop and optimise processes with scale-up, technology transfer and manufacturing already in view. Keeping the work within one connected team protects process knowledge and reduces disruption as your program progresses.
Support
Frequently Asked Questions
Common questions about our microbial process development services. Can’t find what you need? Talk to our team.
Can you optimize an existing microbial process?
Yes. We support process troubleshooting, yield improvement and process robustness for existing microbial manufacturing processes.
Which microbial hosts do you support?
Primarily E. coli, Pichia pastoris and various fungal expression systems, but we also have experience working with Bacillus, Lactobacillus and other microbial hosts.
Can process development be transferred directly into GMP manufacturing?
Yes. Development activities are designed to facilitate technology transfer into GMP production.
Talk With the Team About Your Process Development Project
Tell us about your molecule and current process stage — our team will get back to you as soon as possible.
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