We are always looking for ways to enable the commercialization of Cell-based Therapy and Technology. The ultimate success of the field is dependent on the convergence of several technology fields, and one that isn’t given sufficient attention is the Measurement Sciences (or metrology). The National Institute of Standards and Technology (NIST) has a Biosystems and Biomaterials Division that has several projects focused on their mission of “Building Confidence in Biological Measurements”, and they have several people that are working to advance measurements in regenerative medicine.
On May 11&12, NIST will be holding a workshop focused on Measurement Assurance for Cell Therapy Products. The Registration for the workshop is open and is limited to the first 100 registrants, and the Agenda (below) has speakers from Industry, the FDA, NIST, as well as several breakout workshops to focus on some of the analytics that are the low hanging fruit to bring standardization too.
The adage of “Measure Twice, Cut Once” only holds true if you have robust and precise methods and assays, and solid reference standards for which everyone can compare. Our previous posts on Regenerative Medicine Standardization, and of course the great content on this at the Stem Cell Assays blog are good places for background reading for those interested.
We believe this NIST initiative, and others in the Cell Therapy Manufacturing space, will help the field begin to bring focus and attention to the measurement sciences, and we encourage attendance from all stakeholders.
When: May 11-12, NIST Campus: 100 Bureau Drive, Gaithersburg, MD, 20899
Would you like to improve the reproducibility of your potency assay?
Would you like to have more confidence in your measurements of critical quality attributes?
Do you want to work as a team with your colleagues to improve confidence in the assays that are critical to getting your cell therapy products to market?
As the saying goes, “If you can’t measure something, you can’t improve it.” So please join us as we examine approaches for improving confidence in measurements critical for cell therapy products!
Goal: Examine approaches for improving confidence in the measurements that are necessary for bringing cell therapy products to the market.
Scope: Challenges in achieving reproducibility, accuracy, and comparability in biological assays have been identified as major roadblocks to development, manufacturing and regulatory approval of cell therapy products (CTPs). Improving confidence in measurements for CTPs involves understanding and controlling sources of variability, development of appropriate reference materials to enable traceability and providing objective evidence to validate results. The workshop will focus on strategies to achieve measurement assurance for assays that may contribute to characterizing critical quality attributes and/or potency and will include breakout sessions focused on specific measurements.
Content: The first morning will cover strategies for achieving confidence in measurements, such as traceability, reference materials, validation, uncertainty analysis & inter-laboratory testing. In the afternoon, we will break out into sessions focused on specific measurements, such as cell counting, viability, and functional tests. On the second morning, report-outs will lead the discussion on the key steps that were identified for improving the confidence in the cell measurements that were examined.
Where: In Green Auditorium in Building 101 (the Administration Building) on the NIST Campus
Audience: Industry, Government, Academia
Organizing Committee: Carl Simon (NIST), Anne Plant (NIST), Sheng Lin-Gibson (NIST), John Elliott (NIST), Michael McCaman (Lonza), Jon Rowley (Rooster), Kyle Kolaja (CDI), Pam Robey (NIH), Darwin Prockop (Texas A&M), Steven Oh (FDA), Fouad Atouf (USP)
Monday, May 11, 2015, 9:00am – 5:30pm
9:00 – 9:05: Anne Plant (Chief, Biosystems & Biomaterials Division), Opening remarks
9:05 – 9:10: Laurie Locascio (Director, Material Measurement Lab), Welcome to NIST
9:10 – 9:40: Marc Salit (NIST)
9:40 – 10:10: John Elliott (NIST)
10:10 –10:40: Chris Wiwi (Celgene)
10:40 – 11:00: Coffee Break
11:00 – 11:30: Mahendra Rao (Q-Therapeutics)
11:30 – 12:00: Kyle Kolaja (CDI)
12:00 – 1:15: Lunch
1:15 – 1:45: John Elliott, Charge for breakout sessions
Charge: Discuss how to improve confidence in the assigned measurement. Generate a draft summary of challenges and opportunities with the following considerations…
Identify sources of variability, complete a cause and effect diagram
Develop a flowchart of a robust assay protocol
Sensitivity testing: what parameters need to be tested for ruggedness
Determine needs for reference materials to calibrate or validate results
Identify the required positive and negative controls
Is an inter-laboratory test required?
1:45 – 4:30: Parallel Breakout Sessions:
Breakout #1: Cell Counting
Breakout #2: Cell Viability
Breakout #3: Functional Cell Assay
4:30 – 5:30: Reconvene: Preliminary reports from breakout sections
5:30: Break for the day
Tuesday, May 12, 9:00am – 12:15pm
9:00 – 9:05: Sheng Lin-Gibson (Deputy Chief, Biosystems & Biomaterials Division), Welcome back
9:05 – 11:00: Full reports from breakouts showing cause and effects diagrams, flow charts, needs for reference materials, potential for inter-laboratory studies, etc.
9:05 – 9:45: Breakout#1 Report: Cell Counting
9:45 – 10:25: Breakout #2 Report: Cell Viability
10:25 – 11:00: Breakout #3 Report: Functional Cell Assay
11:00 – 12:00: Carl Simon, Panel discussion with speakers and breakout session leaders
Is there an opportunity for inter-laboratory studies?
What reference materials would be useful?
Cell-based reference materials?
12:00 – 12:15: Concluding remarks