Design and development of novel reactors for manufacturing PEGylated biopharmaceuticals

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Life-saving protein biopharmaceuticals such as monoclonal antibodies and vaccines are increasingly being used**for a range of therapeutic applications. These are usually delivered in the form of injections. Formulating such**products is challenging due to major problems such as immunogenicity and short in-vivo half-life, and stability**issues such as susceptibility to degradation, chemical modification, denaturation and aggregation. Most of these**issues could be addressed by PEGylation which involves the covalent attachment of the synthetic polymer**polyethylene glycol (or PEG) to the protein molecule. BioVectra is a Prince Edward Island based company**with an established track record in manufacturing reagents used for protein PEGylation. However, current**PEGylation processes result in significant by-product synthesis, resulting in lower product recovery and**increased production cost. The proposed work addresses an urgent need expressed by our industrial partner,**BioVectra, i.e. improvement in efficiency of manufacturing PEGylated biopharmaceuticals. We propose to**address this challenge through the design and development of novel and efficient reactors for protein**PEGylation. We have a proven track record in designing and developing novel devices for conducting chemical**reactions and separations. The main attributes of the robust reactors developed in our group include superior**hydraulics, narrow residence time distribution, minimal back-mixing and uniform superficial velocities, all of**which will contribute towards increasing efficiency of protein PEGylation. Improvement in manufacturing**efficiency through the development of the novel reactor systems will increase product recovery, lower**manufacturing cost, and make the product safe for use. Consequently, life-saving medicine for the treatment of**serious diseases would become more affordable and accessible to the Canadian healthcare system. HQP trained**in this project would also be able to join the Canadian workforce and make valuable contributions to the**Canadian economy.