Anton Stetsenko Email & Phone Number

• BioQual Consulting LLC offers biopharmaceutical expertise and practical CMC solutions. The company leverages "biology first" and QbD principles to ensure robust and compliant functional assays for diverse therapies.
• Potency Assay Life-Cycle Management: consult on proof-of-concept, stage-specific design, development, validation, risk assessment, characterization, optimization, and troubleshooting.
• Method Evaluation and Technical Support: provide in-depth method evaluation and audit with on-site support to minimize compliance risks and long-term complications: -- Platform and readouts selection (e.g., ELISA vs..
• Reference Standards and Critical Reagents (e.g., analytical cell banks).
• DoE Applications: leverage DoE principles to improve efficiency including robustness and validation.
• Immunogenicity: ELISA-based methods for HCPs, residual DNA, residual Protein A, and total protein.

Bremerton, WA, US

Bremerton, WA, US

Menlo Park, CA, US

• Spearheaded the development of cell-based assays for the Orca-T drug product with a multi-mode Mechanism of Action leveraging different analytical methods including flow cytometry to perform QC release/stability.

Emeryville, California, US

• Develop, transfer, optimize, troubleshoot, and qualify/validate cell-based assays to assess transgene functional activity for process development and QC release/stability purposes monitoring the quality of materials.
• Establish, train, and lead a group of associates and scientists to support CMC activities toward the late stage of gene therapy.
• Other responsibilities were nearly identical to the previous position with escalated influence on the decision-making process within the CMC bioassay field.

Lausanne, Vaud, Switzerland, CH

• Develop, transfer, optimize, troubleshoot, and validate a variety of test methods including cell-based bioassays for binding and cytotoxicity, HCP, Residual DNA, and Protein A for in-process/release/stability purposes.
• Manage biological characterization, and qualification of critical reagents as well as reference standards by outsourcing to numerous contract testing labs in the US, UK, and EU.
• Other responsibilities were nearly identical to the previous positions with escalated influence on the decision-making process within the CMC bioassay field.

London, United Kingdom, GB

• Develop, optimize, and validate a variety of test methods including PCR-based potency for release/stability monitoring of pre- and clinical gene therapy products for ADA-SCID immune deficiency (STRIMVELIS®) and MPS.
• Other responsibilities were nearly identical to the previous position.

Emeryville, CA, US

• Develop, optimize, and validate in vivo and in vitro test methods (e.g. ELISA) as a potency test method for release/stability monitoring of commercial drug product (HEPLISAV) including development, characterization.
• Oversee life cycle management activities for bioassays and contribute to the development and implementation of orthogonal analytical techniques used for characterization and testing of in-process samples, drug.
• Prepare and review technical documents including development reports, method validation protocols/reports, standard operating procedures, and regulatory documents (e.g. CMC, BLA).
• Manage the activities of external laboratories (CRO/CMO/academic labs) that have been contracted to conduct assay development, characterization, or sample testing.
• Design validation studies and manage tech transfers of assays to QC and CRO in a cGMP environment.
• Lead bioassay group of 2-3 direct reports and provide scientific guidance to the management, technical staff, and cross-functional teams.

Bad Homburg, Hessen, DE

• Established and led a new functional group of Scientists (up to 5 direct reports) to support biological projects in Innovation & Development managing research staff, training personnel and following ICH and cGMP which.
• Organized and managed the bioassay lab to establish a new in-house capability of developing, validating, transferring and troubleshooting bioassays in the cGMP environment by selecting, justifying equipment purchase.
• Design and implement experiments to meet analytic objectives required by cGMP, including data generation for NDA/ANDA submissions, using Quality by Design and Design of Experiments concepts in order to gain approval to.
• Prepare, review, and approve various documentation, including, protocols, reports, SOPs, methods, specifications, and submissions in compliance with ICH and cGMP.
• Accomplished a variety of analytical tasks providing technical support as a Subject Matter Expert to top-management, cross-functional teams, and FDA agents which led to new product release, resolution of.
• Presented a case study “Establishing Early SPC Criteria – Triumphs and Tribulations” at IBC’s 23rd International Intensive Symposium “Development, Validation and Maintenance of Biological Assays”, Seattle 2013

Abbott Park, Illinois, US

• Executed variety of experiments discovering new compounds to control reverse cholesterol transportation through the development protocols and methodologies and the recording of experimental procedures and results in.
• Collaborated with biologists, chemists, engineers and other scientists on the performance of the XIENCE V Drug Eluting Stent, which demonstrated statistical superiority over its main competitor in target lesion.
• Achieved the President Choice award for project research and execution from the Abbot Vascular Technical Poster Awards Committee at the 2007 Technological Scientific Session.

• Researched signal transduction using the rod photoreceptor visual transduction cascade.
• Studied the interactions between head and neck cancers and the innate immune system.
• Researched enzymatic characterization of human microsomal short-chain dehydrogenase projected to oxidize/reduce Rol/Ral in different tissues and cell cultures.
• Mentored graduate students in the areas of research studies and cell/molecular biology techniques.

Doctor Of Medicine, Medical Biochemistry

Master Of Business Administration - Mba, Business Administration And Management, General