The Need for Glycoprotein Analysis & Purification Tools

Glycoselective Process Analytical Tools (PAT): ​In recent years progress has been made towards achieving more consistent and appropriate glycosylation through the development of specifically engineered expression cell lines. However, careful optimization and monitoring of process parameters remains the predominant strategy for controlling  product glycosylation - "The Process is the Product". However, achieving faithful control of product glycosylation through such strategies remains a significant technical challenge. Glycoselective tools enabling the simple and fast monitoring of product quality throughout the production process would help to increase the efficiency of production processes reducing failed runs and production costs.


Inconsistenty in Production Processes: Because of the need for appropriate glycosylation most biotherapeutic products are manufactured through expression using mammalian cell lines as these possess the glycosylation machinery required for the addition of human like glycan structures to products. However, the glycosylation process is highly sensitive to changes in the culture conditions used throughout a production process. Variations in the culture conditions during production runs can result in sub-optimal product glycosylation. 





The High Cost & Complexity of Production: Biotherapeutics are, by their very nature, large complex molecules and most biotherapeutic products in development, and currently being manufactured, are glycoproteins. The glycans present on biotherapetic products can have a significant impact on their efficacy and immunogenicity. Glycosylation is therefore a critical product quality attribute that must be characterised, monitored and controlled. The complexity of biotherapeutic molecules makes their development and manufacture more technically challenging, and expensive, than traditional pharmaceutical products. There is a need to increase the efficiency and reduce the cost of production especially with increased competition from biosimilar products. 





Challenges in Biotherapeutic Production

As our understanding of the complex biological processes that underly many diseases has advanced it has presented new opportunities for therapeutic intervention. By exploiting the power of recombinant DNA technology scientists can now engineer cells to make new protein based therapeutic molecules, biotherapeutics, that offer potential life changing treatments for some of the most debilitating and life threatening diseases including many types of cancer.

Biopharmaceuticals 

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RPLs can be readily integrated into a wide range of analytical platforms to generate enhanced glycoselective tools for applications in product development and potentially for use as process analytical tools. They can also be immobilized onto a wide range of solid support matrices (e.g. sepharose or monolithic supports) to generate glycoselective bioaffinity based purification tools. The scalability of RPL production enables their use for all application scales including large scale purification of biotherapeutic products.

RPLs - Glycoselective Tools for All Application Scales

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Glycoselective Purification Tools: Downstream processing (DSP) is a major bottleneck in biotherapeutic production and can contribute to as much as 80% of the overall cost of production. It is typically a highly complex procedure involving a large number of steps including the use of multiple different chromatographic steps. One of the major difficulties is the inability of these processes to handle the high yields of biotherapeutic product that can now be generated through advanced fermentation processes. Affinity chromatography offers many advantages over alternative chromatographic procedures enabling rapid and efficient isolation of products and their recovery in smaller volumes thereby reducing the required scales of subsequent DSP steps. Glycoselective bioaffinity matrices, capable of selective purification of products based on their glycosylation, could help reduce the complexity and increase the efficiency of downstream processing of biotherapeutic products. They could be implemented for selective isolation of optimally glycosylated product species, or removal of potentially immunogenic species, and reduce the overall glycan heterogenicity of the final product. 

Glycoanalytical Tools for Product Development & Characterisation: Because of the potential impact of inappropriate glycosylation on product efficacy and safety there is a need for tools that enable simple, rapid and potentially high-throughput glycoanalysis of biotherapeutics throughout the product development process. Such glycoselective tools would increase the efficiency and reduce the timelines, and cost, of product development in addition to helping to deliver potentially more efficacious and safer products.

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