Q&A Session with Biosimilar Roundtable Panelists – Dr. Dan Mamelak

Dr. Dan Mamelak headshot

Dr. Dan Mamelak

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Dr. Dan Mamelak is founder and president of contract testing lab Custom Biologics, a Health Canada audited GLP/GMP-compliant, global service provider for functional testing and characterization of biomolecules. Dan has a background in microbiology, immunology and protein biochemistry and over 20 years’ experience in developing and validating reliable and reproducible cell-based bioassays to measure the functional properties of biotherapeutics.

FG: Thanks, Dan, for joining the Biosimilars Roundtable and bringing your functional analysis expertise to our discussion. You joined us from Custom Biologics’ home town of in Toronto, I believe. Have you always lived and worked in Canada? What made you want to establish a CRO then grow it into the GLP-Compliant bioanalytical service provider it is now?

FG: You mentioned in the roundtable discussion that you have a lot of experience in linking your functional testing to specific findings in the structural analyses, for instance glycosylation profiles and S-S bridges. Can you elaborate?

FG: For biosimilars, is there a “typical” suite of functional assays (e.g. binding and cell-based) for each class of molecule? How do these differ between different molecule types, for example mAbs and non-mAbs? What other biological testing is required?