ColdStash Cell Therapy Cassette Specification Questionnaire

Looking for the right cassette fit for your therapy? Fill out the questionnaire below to help us better understand your needs.

Company

Phone

(###)

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Date

YYYY

1) How is the therapy packaged/stored?

2) What size of storage package do you use?

What size is the Cryo bag or vial? How many milliliters?

3) What make and model of bag are you using (Please provide supplier part number)?

4) If using Cryo Bags…

a. Is the bag “standard” from the manufacturer or custom? If custom, what are the overall dimensions and port dimensions?

b. Will you be using over wrap pouch?

c. How will you be labeling?

d. Will you be using bag manufacturers label pouch?

e. Do you want windows in cassette that align with your label?

f. Where will Patient Information Literature (PILS) be stored?

g. What are you plans for “tamper evident” seals?

5) LN2 Storage Freezers

What brand, make and model# freezer(s) do you use?

6) Time and quantity requirements

a. What stage of development is the program?

b. What is the status of clinical trials? i. Timing ii. Projected # patients iii. Projected number of units required (doses)

c. What is your current expectation for Commercialization? i. Target commercialization date ii. Projected volumes upon commercialization

7) Shipping Therapies

a. Have you investigated options for shipper/logistics?

b. Have you chosen a shipping partner?

8) Other things we should know?