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 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?

FG: Thanks for this explanation, Dan. I understand that BioPharmaSpec and Custom Biologics have developed a useful Quick Guide for companies developing biosimilars to answer this very question about typical assay requirements for functional and structural characterization. Thanks again for taking the time to participate in this most recent Biosimilars Roundtable!

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