cold chain for commercialized biologics
TRANSCRIPT
Moving to Modern -A Cold Chain for Commercialized BiologicsHeidi Crawford, BSME, MBA Software Product Manager, SAVSU
January 20, 2017
SAVSU designs and delivers services to meet the diverse requirements of temperature-sensitive biologics delivery.
www.savsu.com New York, New Mexico, Washington
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Topics• Regenerative medicine transport needs• A modern cold chain for cell therapy• Outdated methods• Technology demo and data
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Costly Regenerative Medicine Treatment
“Erin Cross begins lifesaving therapy in Seattle.“-- Chester and Cheshire News, July 28, 2016
100,000 £ raised for transport of patient and her treatment
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A Cell Therapy Treatment Success Story
“New gene-therapy cancer treatment 'wipes out' dying girl's leukemia” -- The Telegraph, December 26, 2016
Photo: Northwest news service
“Her family has been told by Seattle Children's Hospital that blood tests reveal the cancer has completely disappeared.” --The Telegraph, December 26, 2016
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Today’s Outdated Biologics Cold Chain
All vaccines and 70% of
biologics are
temperature sensitive.
Stability of traditional containers is limited.
Cell viability declines. Lost and unusable
doses result.
Regenerative medicine therapies require precise thermal
protection in
shipment.
Use of real-time
temperature
monitoring and
reporting during
shipment is limited.
TIME
Moving to a Modern Cold Chain for Commercialized Biologics
Critical parameters• Cells remain within the product
stability temperature range• The shipment container is not opened
in transit, which could make cells vulnerable to tampering
• The proximity of cells to their destinations is available
• The shipment length is within the product stability time, allowing time for treatment
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Regenerative Medicine Transport Needs
Regenerative medicine ships a variety of products…• Apheresis units• Tissues• Cell-based products• Other
… at a variety of temperatures• Controlled Room Temperature• 2-8 degrees C• Dry Ice• LN2
A Modern Cold Chain for an Autologous Therapy
• An intelligent autologous therapy workflow guides a sample collected in Seattle.
• It is shipped to a GMP facility in Houston, Texas.
• The modern workflow then protects a treatment in transport from Houston to Seattle, Washington.
• The cold chain traverses regions with Winter temperatures ranging from 31°F to 60°F.
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Map source: Weather.com 12/16/2016
evo™ Smart Shippers and biologistex™
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2 - 8°C Use with
pre-conditioned cold packs
CRT15°C - 20°C
Use withpre-conditioned
cold packs
CRYO-80°C
Use with dry ice
Patents Pending
Common Choices for Shipping Biologics
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• Poor performance
• Single use
Foam Coolers Data Loggers Thermal Packaging Liquid Nitrogen Dry Shippers
• Container, not payload temperature
• Data reviewed after clinical product is used
• Overly complex• Prone to pack out
errors• Heavy, expensive to
ship
• Significant variations can occur among shippers
• Some difficulty or delay in shipper returns
• Heavy, expensive to ship
Cold Chain Risks for Biologics
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Economic Clinical
Administering a thermally sensitive biologic dose that:• was exposed to unknown
temperature excursions • was exposed to pack out
errors• has exceeded its stability
period• cannot be replaced Patient death or suffering
Cost of scrapping biologic source material or manufactured cell productsCommercial and clinical trial impact from poor biologistics management:• lost dose • poor shipping container
performance • temperature excursions
Rx $
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evo™ Intelligent Shipper Technology
0.000.250.500.751.001.251.501.752.002.252.502.753.003.253.503.754.004.254.504.755.005.255.505.756.006.256.506.757.007.257.507.758.008.258.508.759.009.259.509.7510.0010.2510.5010.7511.0011.2511.5011.7512.0012.2512.5012.7513.0013.2513.5013.7514.0014.2514.5014.7515.0015.2515.5015.7516.0016.2516.5016.7517.0017.2517.5017.7518.0018.2518.5018.7519.0019.2519.5019.7520.0020.2520.5020.7521.0021.2521.5021.7522.0022.2522.5022.7523.0023.2523.5023.7524.0024.2524.5024.7525.0025.2525.5025.7526.0026.2526.5026.7527.0027.2527.5027.7528.0028.2528.5028.7529.0029.2529.5029.7530.0030.2530.5030.7531.0031.2531.5031.7532.0032.2532.5032.7533.0033.2533.5033.7534.0034.2534.5034.7535.0035.2535.5035.7536.0036.2536.5036.7537.0037.2537.5037.7538.0038.2538.5038.7539.0039.2539.5039.7540.0040.2540.5040.7541.0041.2541.5041.7542.0042.2542.5042.7543.0043.2543.5043.7544.0044.2544.5044.7545.0045.2545.5045.7546.0046.2546.5046.7547.0047.2547.5047.7548.0048.2548.5048.7549.0049.2549.5049.7550.0050.2550.5050.7551.0051.2551.5051.7552.0052.2552.5052.7553.0053.2553.5053.7554.0054.2554.5054.7555.0055.2555.5055.7556.0056.2556.5056.7557.0057.2557.5057.7558.0058.2558.5058.7559.0059.2559.5059.7560.0060.2560.5060.7561.0061.2561.5061.7562.0062.2562.5062.7563.0063.2563.5063.7564.0064.2564.5064.7565.0065.2565.5065.7566.0066.2566.5066.7567.0067.2567.5067.7568.0068.2568.5068.7569.0069.2569.5069.7570.0070.2570.5070.7571.0071.2571.5071.7572.0072.2572.5072.7573.0073.2573.5073.7574.0074.2574.5074.7575.0075.2575.5075.7576.0076.2576.5076.7577.0077.2577.5077.7578.0078.2578.5078.7579.0079.2579.5079.7580.0080.2580.5080.7581.0081.2581.5081.7582.0082.2582.5082.7583.0083.2583.5083.7584.0084.2584.5084.7585.0085.2585.5085.7586.0086.2586.5086.7587.0087.2587.5087.7588.0088.2588.5088.7589.0089.2589.5089.7590.0090.2590.5090.7591.0091.2591.5091.7592.0092.2592.5092.7593.0093.2593.5093.7594.0094.2594.5094.7595.0095.2595.5095.7596.00-5
5
15
25
Hours
Deg
rees
C
External Temperature
2-8°C evo™ Smart Shipper – ISC Silver Cold Profile
96+ hours stability
Temperature insideevo™ tested in triplicate
96 hours
Thank you!
Heidi CrawfordSoftware Product Manager
[email protected], Tel: 425-686-6051-80 C CRYO evo