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Mammalian Process Development
Turn your molecule into a robust, scalable and compliant manufacturing process. At 53Biologics, we design and optimize mammalian processes on CHO and HEK platforms so you can achieve the right balance of yield, cost, robustness, operability and scalability while aligning to current GMP expectations.
Process development turns a selected clone into a robust, scalable process ready for GMP manufacturing.
01
Cell Line Development
02
Cell Banking
03
Process Development
04
Analytical Support
05
Manufacturing
06
Fill & Finish
This service is available also for:
Overview
How Our Process Development De-Risks Scale-Up
Mammalian process development must balance productivity, scalability and regulatory readiness from the outset. 53Biologics addresses common challenges such as low titres, variable cell growth, inconsistent glycosylation, aggregation, difficult impurity profiles and downstream bottlenecks by developing upstream and downstream operations as one connected process. Host and clone performance, media and feed strategies, bioreactor parameters, capture, polishing, viral clearance and UF/DF are evaluated together to avoid solving one issue at the expense of another.
Using representative scale-down models, Design of Experiments and phase-appropriate analytics, we identify the parameters that have the greatest impact on critical quality attributes and build a practical control strategy for manufacturing. This data-driven approach reduces uncertainty during scale-up, engineering runs and technology transfer, helping clients avoid late-stage redevelopment, protect batch consistency and move into GMP manufacturing with a process designed to perform beyond the laboratory.
Types of Molecules We Support
Antibodies
Monoclonal antibodies and other biosimilars: Standardized, rapid development pathways with proven scalability.
Complex Proteins
Like Fc-fusions, bispecifics, and other challenging protein formats requiring advanced process strategies.
Hard-to-Express Proteins
Proteins with complex post-translational modifications, aggregation risk, or low expression yield
Process
Our Mammalian Process Development Workflow
01
Baseline Process Confirmation
Initial operating ranges for inoculation density, temperature, pH, dissolved oxygen and feeding are confirmed in parallel 2 L runs.
02
Media &
Feed
Optimization
Where required, DoE studies evaluate media, supplementation and feeding strategies to improve cell growth, viability, productivity and titre.
03
Scale
Confirmation
Selected conditions are confirmed in 2 L and pilot-scale runs to assess reproducibility, process robustness and product quality trends while generating material for downstream development.
04
Capture Development
Clarified harvest is processed through the selected capture step, with loading, washing, elution and neutralization conditions optimized to protect recovery and product quality.
05
Viral Safety
Strategy
A phase-appropriate viral reduction strategy is defined according to product stability, including compatible inactivation or detergent treatment and virus filtration feasibility.
06
Polishing & UF/DF Development
Scalable polishing technologies and TFF conditions are screened to improve impurity clearance, product recovery, concentration and buffer exchange.
07
Sterile Filtration Feasibility
Sterile filtration conditions are assessed for throughput, recovery and fouling behaviour, creating a stronger basis for scale-up and GMP transfer.
Why Choose 53Biologics for Mammalian Process Development
Work Side by Side with the Experts
Direct access to the scientists developing your process keeps USP, DSP and analytical decisions aligned. Results are reviewed together, enabling faster responses when data reveals new risks or opportunities.
Scientific Depth Across the Full Process
Upstream and downstream development are designed as one connected strategy. DoE, scale-down models and phase-appropriate analytics help balance productivity, product quality, impurity clearance, viral safety, recovery and scalability.
Development Built Around Your Molecule
Media, feeding, bioreactor parameters, capture, polishing and filtration strategies are adapted to your molecule and development stage. The scope can evolve as new data emerges without forcing the program into a fixed platform.
Designed to Progress into GMP
Process development is carried out with scale-up, technology transfer and future manufacturing in mind. Retaining process knowledge within the same team reduces redevelopment, supports robust engineering runs and protects continuity into GMP production.
Support
Frequently Asked Questions
Common questions about our mammalian process development services. Can’t find what you need? Talk to our team.
Can you develop processes from an existing production cell line or manufacturing process?
Yes, we can optimize existing upstream, downstream or integrated manufacturing processes to improve productivity, process robustness, product quality or scalability while maintaining alignment with your development objectives.
When should process development start during a biologics program?
Process development should begin as early as possible, ideally once a production cell line has been selected. Early optimization helps improve productivity, establish product quality attributes and reduce risks during scale-up and GMP manufacturing.
Which mammalian expression systems do you support?
53Biologics supports process development for CHO and HEK mainly and other mammalian expression platforms depending on the characteristics of the project.
What does mammalian upstream process development include?
Upstream development typically includes optimization of media composition, feeding strategies, culture conditions, bioreactor parameters and harvest timing to improve cell growth, productivity and process robustness.
What does downstream process development involve?
Downstream process development focuses on designing and optimizing purification workflows, including clarification, Protein A or affinity chromatography, polishing steps and ultrafiltration/diafiltration, to achieve the required purity, recovery and product quality.
Talk With an Expert About Your Mammalian Process Development Project
Tell us about your molecule and manufacturing goals — our team will get back to you within two business days.
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