Glycoengineered insect cells for commercial biologics manufacturing

DESCRIPTION provided by applicant Therapeutic proteins or andapos biologicsandapos represent a andgt $ billion market that includes a variety of important drugs such as antibodies and hormones The clinical efficacy of many biologics is determined by their sugar structures or andapos glycansandapos Most biologics are manufactured in mammalian cells because they add human type glycans which are needed for the drug to function effectively However mammalian cells have some serious disadvantages For example it takes a long time to establish production cell lines and mammalian cells can produce immunogenic glycans The baculovirus insect cell system BICS offers an attractive alternative system for biologics manufacturing as it lacks these disadvantages However the BICS is currently limited by its inability to produce proteins with human type glycans GlycoBac has developed tools and methods to andapos glycoengineerandapos insect cells allowing them to add human type glycans to recombinant proteins In Phase I of this SBIR project GlycoBac established the feasibility of producing several insect cell lines that can efficiently produce proteins with clinically relevant human type glycan structures Recently it was discovered that GlycoBacandapos s insect cells harbor a previously unknown virus In Phase II we will remove this adventitious agent using a proprietary method recently developed by GlycoBac This will improve the biosafety profile of our glycoengineered cell lines and increase their value for biologics production We will also produce two new cell lines that add two different kinds of branched glycans to proteins Such glycans are known to improve the efficacy for some vaccines and other biologics Another Phase II Aim is to demonstrate the robustness and scalability of our new cell lines as a key requirement for commercial use of the new cell lines will be demonstrated utility under production conditions Finally we will generate cell banks for two glycoengineered cell lines These will be selected based on the performance of the cell lines combined with commercial prospects In summary our project is designed to develop glycoengineered BICS into a versatile platform with proven utility for the production of safe and efficacious biologics at production scales The outcome of this Phase II SBIR project is expected to be a set of insect cell lines that can be used to produce a wide range of biologics with the specific human type glycans that provide optimal efficacy for a particular application The proposed products will have high potential impact as new tools for commercial protein manufacturing GlycoBac also will make glycoengineered BICS available for academic and industrial basic and applied research Thus the tools generated in this project will have a significant and broad impact on human medicine and diverse areas of basic biomedical research PUBLIC HEALTH RELEVANCE This project is designed to overcome the fact that the baculovirus insect cell protein production platform adds insect type sugar structures to proteins which limits the utility of this system for the production of protein drugs andapos biologicsandapos The goalof this project is to develop glyco engineered insect cells into a versatile platform with proven utilty for the production of safe and efficacious biologics at production scales These new insect cells will be useful for manufacturing a wide range of biologics with the specific human type sugar structures that are known to provide optimal efficacy