Support Across Protein Development
Expertise from discovery to GMP-grade microbial production
Sartorius supports recombinant protein production from 100 mg to 40 g, with R&D-, GLP-, and GMP-grade material for preclinical and clinical validation. Using E. coli or P. pastoris production strains, services support proof-of-concept, safety, potency, efficacy, and toxicity studies across therapeutic, vaccine, and diagnostic applications. Manufacturing processes can be transferred to Sartorius GMP facilities or other large-scale GMP production sites.
Explore our custom protein services
At Sartorius, every project is shaped around customer needs, market requirements, and scalable production. We combine process and quality optimization, technology integration, regulatory alignment, and sustainability practices to support efficient recombinant protein development and manufacturing.
Protein production matched to project stage
Our Liège, Belgium site supports custom protein manufacturing for preclinical research and clinical trials.
Pre-clinical: 5 L, 15 L, and 50 L stainless-steel fermenters and chromatography systems.
Clinical: Two full operational GMP suites with 15 L and 50 L fermenters, and chromatography systems.
GMP certificate: BE/GMP/2023/093
Custom protein development workflows
Sartorius provides custom protein development services including project development, experimental design, risk analysis, and consultancy. Capabilities include expression system design and construction, fermentation and purification development, analytical tool development, formulation based on stress and stability studies, and process transfer and scale-up studies.
Manufacturing quality
Ensuring consistent product quality from R&D to GMP is fundamental to our operations. Processes are designed for seamless transfer while maintaining high standards across production volumes and stages. Technical sales, scientists, and quality assurance teams work together to uphold these standards and support optimal production outcomes.
Flexible technology access
Sartorius supports flexible use and transfer of developed technology:
Periplasmic lysis: Patented process is available without fees or royalties
Manufacturing: Developed and transferred processes are not subject to any intellectual property restrictions
Strain: E. coli and P. pastoris strains are available for unrestricted use
Learn more about our technological platforms
Toolbox for rapid selection of expression strains
Production yield strongly influences the accessibility of therapeutic candidates.
Our platform assesses factors affecting recombinant protein synthesis and secretion in E. coli periplasm, including gene copy number, transcription and translation strength, and secretion pathways.
Our platform also assesses more specific factors such as protein synthesis, folding, processing, and secretion in P. pastoris, including secretion efficiency, high-density cultivation, and low endotoxin production.
Optimization platform for fermentation conditions
Our fermentation development platform includes eight 5 L stainless-steel Biostat® Cplus fermenters, representative of industrial systems, and a 50 L Biostat® D-DCU fermenter for scale-up studies.
A standard high cell density fed-batch protocol has been developed, with optimization plans evaluating several parameters that impact yield and protein activity.
Rational design for purification development
The standard purification process includes capture and polishing chromatography, followed by ultrafiltration. Chromatography chemistry is selected based on the protein's physicochemical properties, with solubility trials and Design of Experiment (DoE) approaches used to define conditions. These conditions are evaluated in 5 mL columns before scale-up to larger columns.
Rational selection of analytical methods
We use a systematic approach to select analytical tools for assessing process performance and protein quality. During purification, we evaluate recovery, purity, integrity, and aggregation. The purified protein is comprehensively characterized for identity, purity | impurity, safety, and biological activity using various analytical methods.
Rational selection of analytical methods
We use a systematic approach to select analytical tools for assessing process performance and protein quality. During purification, we evaluate recovery, purity, integrity, and aggregation. The purified protein is comprehensively characterized for identity, purity | impurity, safety, and biological activity using various analytical methods.
Our quality management system
Phase-appropriate quality oversight, documentation, and traceability
Our quality management system is based on regulatory requirements and GMP guidance. Key principles include:
Risk management: Identifies, assesses, and mitigates risks to ensure product quality and compliance.
Quality agreement: Outlines quality standards and responsibilities in a formal agreement between parties.
Cross-contamination management: Prevents contamination between different products or batches.
Training, qualification, and internal audit programs: Ensures personnel are properly trained and qualified, with regular audits to maintain standards.
Electronic quality management system: Digitalizes quality processes for efficiency and traceability.
Deviation and corrective and preventive actions: Defines how deviations are investigated, documented, and addressed.
Change control | analytical validation: Manages changes and validates analytical methods to ensure consistency.
TSE- and BSE-free: Documents material origin and supports confirmation of TSE- and BSE-free status with certificates of origin.
Supplier qualification: Evaluates and approves suppliers to ensure they meet quality standards.
Environmental, product quality, and raw materials controls
Monitors and controls environmental conditions, product attributes, and raw materials to maintain quality standards.
