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Dan Mamelak

Founder and President - Custom Biologics
Mississauga Ontario, CA

Position - Company  
Founder and President - Custom Biologics

I am a PhD–trained scientist with a background in microbiology, immunology and protein biochemistry. I have over 15 yrs experience building and operating research-based biopharmaceutical companies in Toronto, Canada.

My passion is to continue building a specialty contract research organization (CRO) that focuses on GLP-compliant bioanalytical testing of biologics and small molecules.

My strong scientific background, ‘can-do’ attitude and many years experience operating and working in a GLP/GMP regulatory environment provide the critical expertise to design, develop and validate reliable and reproducible cell-based bioassays and LCMSMS bioanalytical methods to specifically accelerate our clients’ drug development programs.

The ability to attract and work alongside the brightest scientists and secure the trust and confidence from multi-national biopharmaceutical drug companies to assist in the development of their novel drug products has been very rewarding.

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Jan 2004 - Present
Director - Custom Biologics

Custom Biologics is a GLP/FDA (21 CFR Parts 11 and 58) compliant laboratory that provides specialty contract research/assay development services for drug development programs. Our specialty is bio-analtycial LC/MS/MS and bio-assay (ELISA, immunogenicity, flow cytometry) development and validation.

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Jan 2004 - Present
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