CMC Potency Solutions
Your partner in CMC and functional assay excellence
Fit-for-Purpose Method Development
Mechanism-of-action representative and QC-friendly model systems for the potency assessment of a broad panel of biopharmaceuticals
Method evaluation and troubleshooting, implementation of appropriate controls, reference standard management, and selection and qualification of critical reagents
Practical and statistical solutions for potency assurance, including data trending and customized templates tailored to each client’s specific needs
Potency Assay Life-Cycle Management
Data Analysis and Integrity
About BioQual Consulting LLC
Anton Stetsenko is the Principal Consultant and Founder of BioQual Consulting LLC, a firm specializing in CMC potency method development, validation, and troubleshooting. BioQual’s expertise spans in vitro enzyme activity assays, cell-based assays, immunoassays, and animal models.
Anton has held key roles at Abbott Laboratories, Fresenius Kabi (formerly APP Pharmaceuticals), Dynavax Technologies, Orchard Therapeutics, ADC Therapeutics, 4D Molecular Therapeutics, and Orca Bio. Across these organizations, he led the full lifecycle of potency method development, including comparability studies, validation, method transfer, personnel training, data tracking and trending, customized data analysis, regulatory submission preparation, reference standard strategy, and qualification of critical reagents.
His career has provided deep insight into the unique CMC potency challenges across diverse biopharmaceutical modalities including small molecules, biosimilars, vaccines, mAb's (including bi- and trispecific), antibody-drug conjugates, gene therapies, and cell therapies, ranging from hands-on lab work to strategic planning.
Anton is also an active member of the Board of Directors at BEBPA (BioPharmaceutical Emerging Best Practices Association), where he contributes to advancing industry standards and fostering collaborative dialogue across the global biopharma community.
Anton holds a Doctor of Medicine degree with a focus in clinical biochemistry from the Russian National Research Medical University, and an MBA in General Business from Lake Forest Graduate School of Management.
