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Topics• Regenerative medicine transport needs• A modern cold chain for cell therapy• Outdated methods• Technology demo and data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Today’s Outdated Biologics Cold Chain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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Serving the Patient With a Cell Therapy Workflow

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biologistex™ Software as a Service Technology

05/03/2023 9

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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

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biologistex™ SaaS Results - 111 Hour Workflow

Thank you!

Heidi CrawfordSoftware Product Manager

h.crawford@savsu.com, Tel: 425-686-6051-80 C CRYO evo