FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products.

The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine. Here, we describe the roles of standards in regenerative medicine as well as the process for standards development and the interactions of different entities in the standards development process. Highlighted are recent coordinated efforts between the U.S. Food and Drug Administration and the National Institute of Standards and Technology to facilitate standards development and foster science that underpins standards development.

Summary of the National Institute of Standards and Technology and US Food And Drug Administration cell counting workshop: Sharing practices in cell counting measurements.

The emergence of cell-based therapeutics has increased the need for high-quality, robust and validated measurements for cell characterization. Cell count, being one of the most fundamental measures for cell-based therapeutics, now requires increased levels of measurement confidence. The National Institute of Standards and Technology (NIST) and the US Food and Drug Administration (FDA) jointly hosted a workshop focused on cell counting in April 2017 entitled "NIST-FDA Cell Counting Workshop: Sharing Practices in Cell Counting Measurements." The focus of the workshop was on approaches for selecting, designing and validating cell counting methods and overcoming gaps in obtaining sufficient measurement assurance for cell counting. Key workshop discussion points, representing approximately 50 subject matter experts from industry, academia and government agencies, are summarized here. A key conclusion is the need to design the most appropriate cell counting method, including control/measurement assurance strategies, for a specific counting purposes. There remains a need for documentary standards for streamlining the process to develop, qualify and validate cell counting measurements as well as community-driven efforts to develop new or improved biological and non-biological reference materials.

Two-dimensional gradient platforms for rapid assessment of dental polymers: a chemical, mechanical and biological evaluation.

OBJECTIVES: The increased usage of composite dental restorations underscores the need for continued improvements in material properties. Well-controlled sample fabrication and reproducible methods to quantify and compare material properties will accelerate material design and optimization. Our objectives were to fabricate samples encompassing a range of processing parameters and develop techniques that systematically quantify multiple properties of these samples, thus reducing sample-to-sample variation while concurrently testing numerous processing conditions. METHODS: Gradient samples were prepared to evaluate the effects of composition and irradiation time. Comonomer ratio of 2,2-bis[p-2'-hydroxy-3'-methacryloxypropoxy]-phenyl]propane (BisGMA) and triethylene glycol dimethacrylate (TEGDMA) was varied discretely, and irradiation time was varied continuously across each composition. Degree of conversion was measured using infrared spectroscopy, mechanical properties were evaluated using nanoindentation, and cell viability and density were quantified using fluorescence microscopy. RESULTS: Higher BisGMA contents increased elastic moduli while higher TEGDMA contents increased conversions. Cell response depended only on irradiation time and not composition, with conversions of at least 52% and 60% required for unaffected viability and cell density, respectively. A single composition-irradiation combination to achieve all of the 'best' properties (highest conversion, highest elastic modulus, lack of cytotoxicity) was not identified, illustrating the necessity of testing all combinations for multiple relevant properties. SIGNIFICANCE: Simultaneously screening composition and conversion increased the experimental throughput and allowed for the quantification of chemical, mechanical, and biological properties in a controlled, reproducible fashion. This 2D gradient approach is useful for optimizing compositions and processing parameters to achieve the desired combination of properties.