La Vista, NE – Streck, Inc. will sponsor a free one-hour webinar on “Quality Pillars for Building Measurement Assurance in Flow Cytometry” featuring speaker Dr. Virginia Litwin, Vice President, Immunology, Caprion Biosciences. The webinar will begin at 1 p.m. Eastern Standard Time on Nov. 14, 2018.
The webinar will provide updates on the current best quality practices in flow and provide specific case studies.
Flow cytometry is one of the most valuable and versatile tools for multiparametric, single-cell analysis. The technology has been used in research, clinical and industrial settings for more than 30 years. More recently, flow cytometry has become an integral component of the drug discovery and development process as novel therapeutic approaches targeting the immune system are being applied in oncology and infectious diseases. Arguably for cell therapies, flow cytometry is the most critical tool for purity, identity and potency evaluation during the manufacturing process. Flow cytometry data supporting manufacturing as well as safety and efficacy during clinical evaluation are critical components of biological license applications submitted to regulatory agencies.
As the technology advances and the applications of flow cytometry expand, it is increasingly important to ensure that measurements are made precisely and with certainty. In flow cytometry the quality pillars for building measurement assurance include: instrument characterization and standardization; developing and validating high quality methods; as well as monitoring instrument and assay performance. In the past few years, significant progress has been made in all three areas due to the efforts of the National Institute of Standards and Technology (NIST), the U.S. Food and Drug Administration (FDA), the American Association of Pharmaceutical Scientists (AAPS), the International Society for Advancement of Cytometry (ISAC), and the International Clinical Cytometry Society (ICCS).
Virginia Litwin is a thought-leader in analytical method validation and standardization for flow cytometry. Bringing “Cytometry from Bench to Bedside” has been the focus of her professional activities since 1999 when she started working in translational medicine at Bristol-Myers Squibb.
She co-founded the Flow Cytometry Action Program Committee (APC) within the American Association of Pharmaceutical Scientists (AAPS). This group published the first papers on flow cytometry method and instrument validation, which Virginia was invited to present at the FDA Workshop on Clinical Flow Cytometry in 2013.
Dr. Litwin is the chair of the Document Development Committee for a new Clinical Laboratory Standards Institute (CLSI) Guideline, H62: Validation of Assays Performed by Flow Cytometry. She is a councilor for both the International Society for the Advancement of Cytometry (ISAC) and the International Clinical Cytometry Society (ICCS). In addition, she serves on the ICCS Advocacy Committee, whose mission is to interface with regulatory agencies.
Dr. Litwin edited the book, Flow Cytometry in Drug Discovery and Development (Wiley-Blackwell), a Special Issue of the Journal of Immunology Methods on Flow Cytometry Biomarkers and Translational Medicine, and a Special Issue of Cytometry Part B dedicated to Receptor Occupancy.
After obtaining a Ph.D. in Virology/Immunology from the University of Iowa, Dr. Litwin joined Lewis Lanier at DNAX as a post-doctoral fellow. She was the scientific leader for flow cytometry at Covance from 2010 to 2017, where she was also the first recipient of the Covance Science and Technology Award. Recently, she joined Caprion Biosciences as Vice President, Immunology.
About Streck, Inc. Established in 1971, Streck develops and manufactures hematology, immunology and molecular biology laboratory products. Innovative products include kits for antibiotic resistance detection and a hot-start PCR enzyme. For more information, visit www.streck.com.