What is a Biobetter?
Biobetters are proteins that are biosuperior when compared to the innovative biological, based on a molecular or chemical modification that may translate into an improvement over the reference protein product.
Why not a Biobetter?
Whether your goal is to develop a Biobetter or after the comparative characterization work has been completed, and it becomes clear that your protein is not suited to be a Biosimilar, perhaps a Biobetter strategy should be pursued.
At Goodwin Biotechnology, Inc. (GBI) we can partner with you to develop a strategically sound approach that is designed to cost-effectively produce a high quality Biobetter as rapidly as possible.
Biobetter strategy improvements/modifications can be made by protein or glycol-protein engineering:
Another strategy is to leverage our unique and unrivalled expertise in the research, development, validation and multi-gram GMP manufacture of bioconjugates. GBI has many years of experience and multiple patents pending in protein modifications through chemical conjugation of cancer drugs, protein toxins, bifunctional ligands and metal chelates (for radio-isotope labeling), antibodies and other biological molecules onto monoclonal antibodies and recombinant proteins. The conjugates are then used for diagnostic and/or therapeutic purposes. The benefits of bioconjugation and protein modification are:
GBI also has both the expertise and experience in protein modification utilizing either chemical conjugation or enzymatic digestion. Antibody modification through enzyme digestion is another GBI staff specialty. The production of Fab and F(ab')2 fragments and their subsequent purification can be achieved to a client's specifications. These processes are GMP compliant and scalable to multi-gram lot sizes for clinical applications.
To learn more about Characterizing your Biobetter, click here