High-yield, scalable, and cost-efficient purification processes
VALIDOGEN develops robust, scalable, and efficient protein purification processes that seamlessly integrate with upstream protein production. Leveraging extensive expertise in Pichia pastoris and advanced chromatography techniques, VALIDOGEN’s downstream process development ensures high yield, purity, and cost-effective production of recombinant proteins for biopharma, industrial, and diagnostic applications.
VALIDOGEN’s protein purification development service complements strain development and protein production fermentation with a fully integrated downstream process development approach.
Our downstream processing (DSP) experts design, optimize, and scale purification workflows to ensure high yield, purity, and process robustness across all application areas - from biopharmaceuticals to industrial enzymes.
In close collaboration with our customers, we optimize chromatography steps, determine binding capacities, and fine-tune process parameters to achieve the desired product quality while maintaining cost-efficiency and scalability. We also design and refine non-chromatographic purification methods, including microfiltration, ultrafiltration, and diafiltration, to complement chromatographic steps or, where appropriate, to serve as stand-alone, economically efficient purification solutions.
This integrated approach, spanning cultivation, purification, and analytics, enables efficient, high-quality recombinant protein production suitable for diverse industries and regulatory frameworks.
Seamless coordination between cultivation and purification ensures optimal process design, higher yields, and faster development timelines.
From rapid feasibility setups to full downstream process development, we deliver scalable purification workflows tailored to your protein and application.
In-house analytical capabilities ensure precise monitoring of purity, yield, and impurity clearance, enabling smooth process transfer and supporting regulatory documentation.
Seamless coordination between cultivation and purification ensures optimal process design, higher yields, and faster development timelines.
From rapid feasibility setups to full downstream process development, we deliver scalable purification workflows tailored to your protein and application.
In-house analytical capabilities ensure precise monitoring of purity, yield, and impurity clearance, enabling smooth process transfer and supporting regulatory documentation.
At VALIDOGEN, downstream process development is an essential part of the UNLOCK PICHIA® platform, ensuring that every recombinant protein produced in Pichia pastoris can be efficiently purified and delivered in the desired quality and format.
Depending on project needs, we offer both rapid purification setups and comprehensive purification process development:
For early-stage evaluation, VALIDOGEN quickly establishes small-scale purification protocols, providing highly pure milligram to gram quantities of target protein directly from Pichia culture supernatants. Standard purification methods - including ion exchange, hydrophobic interaction, and affinity chromatography - are combined with ultrafiltration steps to meet specific purity and recovery requirements.
Our DSP team conducts in-depth process optimization to establish a robust and scalable purification process. This includes evaluating chromatography resin capacities, maximizing yield and purity, defining impurity clearance, and characterizing interdependencies between unit operations. Comprehensive documentation ensures smooth technology transfer to the customer’s production site.
All downstream development activities are supported by VALIDOGEN’s extensive analytical toolbox, comprising PAGE, capillary electrophoresis, HPLC, Western Blot, ELISA, and quantification of host cell protein (HCP) and host cell DNA impurities. Our state-of-the-art equipment and experienced team guarantee that your recombinant protein purification is efficient, reproducible, and compliant with regulatory expectations.
Yes. Our development work is always guided by scalability. The downstream processes we optimize in our labs are designed to transfer seamlessly to industrial production, ensuring that yield, purity, and product quality are maintained at large scale.
We initially develop purification processes using small, few mL pre-packed columns, and then scale up to 500 mL column volumes to process samples from our 10 L bioreactors. VALIDOGEN is not a GMP facility; rather, we deliver fully developed, tech-transfer-ready processes that can be handed over to your chosen CDMO for GMP manufacturing. We have successfully completed many of these transfers.
A tech-transfer-ready process is robust and thoroughly characterized, featuring optimized chromatography conditions, reproducible performance, and comprehensive documentation. This enables a CDMO to implement the process at larger scale without the need for additional major development work.
We apply a broad range of chromatographic and non-chromatographic purification methods depending on the target protein and its application. Chromatographic techniques typically include ion exchange, hydrophobic interaction, mixed mode, and affinity chromatography, often combined in multi-step strategies to achieve the desired purity and yield.
In addition to chromatography, we can apply diafiltration, ultrafiltration, precipitation, and extraction methods as part of the purification workflow. These approaches can simplify the process, reduce costs, or serve as preparatory steps before final chromatographic purification.
Purity levels depend on the protein and intended use. In most cases, our workflows achieve high-purity protein suitable for research and preclinical applications. For industrial enzymes, purification can be tailored to cost-effectiveness rather than maximum purity, while for therapeutic candidates, very high purity levels can be reached through optimized multi-step processes.
VALIDOGEN's expert team is happy to discuss your project and help find the right solution. Send any project related requests to project@validogen.com, directly to our scientists, or use our contact form.
