Recombinant proteins
Therapeutic proteins are versatile tools in the field of medicine. Due to their nature, they offer a precise and targeted approach to address various medical diseases and disorders. From monoclonal antibodies to complex products, Eurofins CDMO is your trusted partner for your development and manufacturing needs.
Complex protein products
Combining years of expertise in the field, our company takes pride in being a reliable partner when protein complexity matters. Relying on highly educated and seasoned personnel with a strong knowhow, and backed by an extensive range of in-house analytical methods to support activities from cell line development up to drug product development, we successfully managed projects involving the manufacturing of:
- Enzymes
- Fusion proteins (e.g. Fc fusions)
- Virus-like particles (VLP’s)
- Clotting factors
- Interleukins and growth factors
- Antibodies, antibody fragments and ADC’s
Starting with a cell line
The choice of cell line is crucial when expressing a recombinant protein. Several factors affecting yield, functionality and overall quality of the recombinant protein are considered in the selection process. While the target protein to be manufactured is a main driver (ex. need for post-translational modification, protein folding and stability, protein solubility) also regulatory and economical aspects (expression level, cost and time, scalability of the process) should be evaluated.
Eurofins CDMO works with different expression systems like E.coli, yeast cell lines, as well as mammalian cell lines (CHO, HEK293, hybridoma).
We onboard your microbial manufacturing project from the early beginnings. Our microbial cell line development services entail:
- Screening of clones for periplasmic secretion, soluble and inclusion body expression in E.coli
- Screening of clones for expression of secreted protein in yeast (Pichia pastoris, Saccharomyces, Hansenula)
- Cell banking services from development (RCB) to GMP (MCB/WCB)
- Stability studies
- Documented cell line generation for easy transfer to GMP
For mammalian cell line development we can tap into the expertise of the Eurofins network or carefully selected partners.
Biotherapeutic production
From microbial to mammalian production platforms, Eurofins CDMO provides comprehensive solutions to cater the diverse needs of our clients in the biopharmaceutical industry from early development to phase 2 clinical studies.
Microbial production capabilities
- High-efficiency fermentation: from process development in parallel bioreactor systems to stainless steel and single-use fermenters at various scales, we can support small-scale productions as well as large-scale manufacturing using batch or fed-batch processes.
- Targeted expression: next to cytosolic protein production, we can engineer bacterial systems to direct protein expression to the periplasmic space, facilitating protein folding and purification.
- Scalable manufacturing: based on a good understanding of critical process parameters, we develop processes with commercial manufacturing as a goal.
- Comprehensive downstream processing: our DSP capabilities include centrifugation, high pressure cell disruption, refolding of inclusion bodies, precipitation, chromatography and filtration (TFF, UF/DF and end filtration)
- Regulatory compliance
Mammalian production capabilities
Our mammalian cell culture facilities offer:
- Flexible cell culture systems: our platform supports diverse cultivation methods, i.e., fed-batch and perfusion processes, across wide-range of development and pilot scales. From small-scale parallel testing (100-250 mL) and bench scale (5-10L) capabilities to large-scale pilot manufacturing (50-200L), our upstream team can deliver scalable process for maximizing production of diverse array of biologics. With various expertise in improving harvest techniques, such as depth and sterile filtration, we can effectively clarify cell culture from cell-based debris and ensure consistent product quality
- Customized DSP solutions: next to our broad range of DSP capabilities, we focus for mammalian cell line projects especially on viral safety by including viral clearance steps in the manufacturing process and coordinating viral clearance studies.
- Robust analytical development and bioassay capabilities for advanced evaluation and characterization of critical quality attributes
- Robust and scalable process development and optimization
- Full GMP compliance: our facilities and operations are fully compliant with GMP standard, ensuring the highest levels of quality and regulatory adherence
Complexity in the spotlight: manufacturing phage lysins
Phage lysins, also known as endolysins, are enzymes produced by bacteriophages to facilitate the release of newly formed phage particles from bacterial hosts. In medicine, phage lysins are being explored for their potential therapeutic applications. This class of proteins was shown in various animal models to be a promising alternative or complement to traditional antibiotics and to combat the increasing threat of antibiotic-resistant bacteria.
It is important to rely on a CDMO with a solid experience in this field, as producing endolysins recombinantly presents different challenges. To name some:
- Toxicity of the target protein to the host cell
- Formation of inclusion bodies and aggregates
- Protein folding and stability to maintain enzymatic activity
- Purification challenges
We successfully supported several endolysin projects from early development to clinical manufacturing.
To learn more