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 including generics, recombinant proteins, monoclonal antibody products, antibody-drug conjugates, biosimilars, prophylactic vaccines, gene and cell therapies.The services encompass the following areas applicable to enzymatic assays, immunoassays, cell-based assays including flow cytometry, and in vivo animal models:• 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. SPR, cAMP vs. ion-flux); -- Control strategy (assay controls, reagent controls) -- Models for data analysis (e.g., slope ratio, PLA, 3-, 4- or 5-parameter logistic models); -- Outlier detection including SoftMax Pro templates for model-based algorithms; -- Integration of data export, tracking, and trending tools.• 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.• Method Transfer and Comparability Studies: transfers for academic/R&D labs and outsourcing contract labs.• Development of Phase-Appropriate Specifications.• Regulatory Submissions and Responses (e.g., BLA CMC section, storyboards/briefing books, etc.).• Computerized System Validation: compilation of URS and DS, assistance with IOPQ.

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 testing, comparability, and biological characterization studies for clinical trials including Ph3 Precision-T.

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 for five different 4DMT programs including biological characterization, and qualification of critical reagents and standards.• 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 of monitoring the quality of materials for six different ADC programs including recently approved ZYNLONTA• 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 disorder including development, characterization, and qualification of critical reagents and standards.• 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, and qualification of critical reagents (e.g. mAb) and standards. • 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 substance and drug product following ICH guidelines and QbD principles.• 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.• Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.• Achieved 2015 and 2016 Excellence awards for the team effort to solve potency OOS case and successful completion of in vitro method for relative potency to replace the current in vivo method correspondingly.

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 led to over $3M in savings, numerous of FDA product approvals and improvement of department’s productivity. • 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 for over $1M and providing technical expertise for equipment qualification which led to the significant reduction of outsourced assays, improved assay quality, and operational throughput.• 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 launch new products and modernize aging products, such as heparin sodium.• 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 Out-of-Specification / Out-of-Trend incidents and deviations, and completion of numerous of projects.• 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 order to develop competitive advantage in the healthcare field.• 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 failure, in-segment late loss and in-stent late loss and was projected to achieve over $923M in sales. • 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