The manufacture of complex biotherapeutics requires novel purification strategies, which may not always exist. Our custom ligand and chromatography resin services enable the development of innovative purification resins, providing a solution for challenging downstream processes.
Capabilities and experience
Through our custom chromatography services, we can design custom affinity ligands and custom resins to solve your purification challenges. Our experienced team of scientists and engineers has a successful track record in resin development, scale-up, and commercialization. Partnering with us will provide you:
- Custom prototype resin that solves your manufacturing challenges
- Scale-up and commercial production of the customized resin to lot sizes of 250L in a GMP facility
- Regulatory support documentation of your custom resin used in regulated environments
- World-class application support that has been developing and manufacturing chromatography resins for more than two decades
Our CaptureSelect affinity resins utilize single-chain antibodies resulting in high specificity and a high degree of purification in a single step. By offering a simplified workflow, product purity and yield increases and helps reduce manufacturing time and costs.
Our POROS technology is used for high-performance, high-throughput bioseparation. These resins demonstrate exceptionally high binding capacity, high greater resolution, and better salt tolterance all over a broad range of operating flow rates. The resulting simplified workflow, increases product purity and yield, and helps reduce manufacturing time and cost.
Enabling Custom Solutions for Downstream Processing for Future Therapies: AAV Case Study
Innovative purification resins have been developed through the POROS custom resin program and CaptureSelect ligand technology in close collaboration with our customers for manufacture of novel molecules, including RNA and DNA oligomers as well as viral vectors and other novel protein therapeutics, for which there was no standard purification strategy. This combination of our core competencies in ligand and resin development has allowed for development of platform purification processes that increase productivity and improve product yield.
Enabling custom solutions for downstream processing
Here we present custom downstream processing solutions, developed in close collaboration with our customers, including a case study covering the single step purification of prothrombin. Custom resin production can start with affinity ligand development or with existing affinity ligands provided by the customer.
C-tag affinity tag, from routine protein purification to use in a cGMP production process
Epitope tagging is a technique that employs genetic engineering to fuse a known epitope, called an affinity tag, to either the C or N terminus of a recombinant protein. Although the use of an affinity tag simplifies the purification and detection of proteins, the tag can alter functionality and stability of the expressed protein and negatively impact final production yields. C-tag is a versatile and user-friendly affinity tag, overcoming the current challenges and limitations of tags in protein purification and detection.
Camelid VHH affinity ligands enable separation of closely related biopharmaceuticals
In this work we describe custom affinity chromatography development using camelid VHH antibody fragments as “tunable” immunoaffinity ligands for separation of product-related impurities. One example demonstrates high selectivity for a recombinant immunotoxin where no binding was observed for an undesired deamidated species. Also discussed is affinity purification of a coagulation factor through specific recognition of the gamma-carboxylglutamic acid domain.
Pharmaceutical Grade Reagent. For Manufacturing and Laboratory Use Only.