“Over the past two years BioOutsource has worked with four customers with ADCs and we have a partnership with two companies with linker technology,” Daniel Galbraith, chief scientific officer for BioOutsource, told us. “We see many more molecules moving to the clinic where our services are essential for approval to move into clinical trials.”
Newcastle-upon-Tyne-based Glythera's core technologies include: PermaLink, which is for the selective and stable functionalization and conjugation of protein and peptide based therapeutics; and PermaCarb, which maximises the in vivo benefits of your glycosylated therapeutics with a range of degradation resistant glycan analogues.
“ADC molecules have three components the most complex from a biological standpoint is the monoclonal antibody, characterisation of this is essential to ensure the molecule will be clinical efficacious,” Galbraith added. “Most of the important characterisation done on a monoclonal is biological assays which BioOutsource excels at. The conjugation of a toxin to the monoclonal can change some of the biological activity of the molecule which may retain all or some of the features of the monoclonal, BioOutsource can characterise this.”
He added: “In addition the cytotoxicity measure of the ADC which is essentially the potency needs to be measured both ‘on target’ and ‘off target’ using many different in vitro methods – again BioOutsrouce can offer this.”
As far as specific therapeutic areas that BioOutsource is focused on, Galbraith said oncology “seems to be the most important just now but this may change.”
Glythera is an early stage company with new linker technology which needs to be validated pre-clinically, and “our partnership offers part of this characterisation to develop assays which can be used for similar molecules in the future,” Galbraith said.
Chief Operating Officer at Glythera David Simpson added, “We are delighted to have the opportunity to work with BioOutsource on their ADC characterisation as it is an area where our linker technologies offer significant benefits.”
BioOutsource has also announced that it will be exhibiting at the World ADC Summit in Frankfurt, in partnership with Aptuit, Glasgow, a pharmaceutical services company, and with support from Scottish Development International.