Downstream process development
Downstream process development solutions to help you achieve maximum purity and yield. Optimize your downstream processes with our comprehensive CDMO services, including purification process development, process characterization and protein refolding (for bacterial origin denaturing format molecules).
What is downstream process development?
A critical step in biologics production, downstream processing involves the purification and isolation of the desired product from the cell culture harvest. Downstream process development and protein refolding (for bacterial origin denaturing format molecules) are designed to maximize yield, minimize costs and ensure the highest quality final product.
It involves a series of intricate steps including:
- Purification process development
- Protein refolding
- Purify your biologics with capture, intermediate and polishing steps
- Ion exchange, metal-chelate, hydrophobic interaction, ceramic hydroxyapatite, gel permeation, reverse-phase, mixed-mode, affinity, pseudo-affinity and filtration-based chromatography capabilities
Protein refolding
Downstream protein refolding helps to ensure the correct folding and assembly of biologics, which is essential for the safety, efficacy and stability of the final product. Once biologics have been purified and refolded, they need to be purified again to remove any impurities or aggregates generated during refolding. The purified biologic is then ready for formulation steps.
Proper protein refolding prevents the formation of aggregates and other misfolded species, which can lead to immunogenicity, reduced potency and other adverse effects. Optimizing refolding conditions is a complex process that requires a deep understanding of the protein’s structure and stability.
Partnering for success: Enzene’s downstream process development solutions
Enzene understands the critical role of downstream processing in delivering high-quality biologics. Our comprehensive suite of CDMO solutions is designed to optimize your purification, characterization and protein refolding processes, ensuring maximum yield, purity and efficacy.
Partner with us for:
Downstream expertise:
From early-stage purification with a wide range of chromatography techniques to late-stage process refinement and scale-up, we offer tailored solutions to meet your specific needs at any stage of development.
Optimized protein refolding:
Ensure the correct folding and assembly of your biologics with our specialized protein refolding methods, maximizing their therapeutic potential and minimizing the risk of immunogenicity and reduced potency.
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Fueled by our continuous innovation and armed with EnzeneX™, our fully-integrated CDMO solutions and our biosimilars pipeline are designed to help bring your biologics innovations to life.