Project: Specification for Printability of Bioink

Type: Standards Advancement Project

Partners: ASTM International and The SCB Cell Therapy and Tissue Engineering Sector Working Groups

Description:

Bioprinting—a method that uses 3D printing techniques to synthesize living tissues—is a rapidly expanding field within regenerative medicine with the potential to accelerate the testing timeline for new biopharmaceuticals that can treat a variety of conditions. Bioinks are used in bioprinting to mimic the extracellular matrix that supports cells in three dimensions. As an emerging field with many different manufacturers and academic researchers independently developing products, there is a lack of standardization for bioink properties such as viscosity and concentration and for bioink printing parameters such as the distance between the nozzle and printing space. Standards in this area will allow product developers to more easily reproduce test results and control product quality.

SCB is coordinating the development of an ASTM documentary standard that will define the range of desirable properties of bioinks to facilitate advancements in bioprinting.

Anticipated Availability: Late 2020

Progress:

Chart of project phases, steps, and anticipated completion dates

Note: Projected dates are estimates only. Development of a standard depends on SDO timelines, which can vary.

Convening Experts: SCB is coordinating a team of experts in the development of an initial draft of this standard. SCB is currently expanding this working group of experts and has initiated biweekly project calls to coordinate the standards development effort.

Assessing Bioink Equipment Standards: As a complement to these efforts, SCB is also working with the American Society of Mechanical Engineers (ASME) and the Institute of Electrical and Electronics Engineers (IEEE) to coordinate the development of potential standards around the validation of bioprinting equipment and the verification of its electrical components.

Get Engaged:

To join the working group or learn more about this initiative, please contact SCB’s Technical Program Manager Kelly Sauerwein (ksauerwein@regenmedscb.org).