must

should

may

MITAP Checklist

1) Cells before

a) Essential information about the donor

i) Species and strain

Species

Strain (if applicable)

ii) Characteristics of the organism

Health

Age

Treatment/Environment
Individual identifier number
Source of purchase (if applicable)

b)

Source of cell material

Organ, tissue, fluid or blood product
Source (if applicable)
Quantity (volume, size or weight)
Anti-coagulant (if applicable)

I

I

c) Cell separation process

Cell separation method
Equipment used

Tissue conditions between tissue retrieval and cell separation
Duration
Temperature
Fluid

Container

Purity of the cells after the separation process
Methodology

d) Phenotype

i) Morphology

Shape and appearance of cells

ii) Cell surface and intracellular markers

Molecules measured (using CD names)
Methodology

Stimulus and time of stimulation (if applicable)

must

should

may

iii) Secreted molecules

Molecules measured
Methodology

Stimulus and time of stimulation (if applicable)

e) Cell numbers

i) Absolute cell number

Total number of cells at the end of the isolation process
Methodology

ii) Viability

Percentage of viable cells
Methodology

2. Differentiation and induction of tolerogenicity (diff/tol)

a) Pre-culture conditions

Storage time
Storage conditions
If fresh

Fluid

Container
Temperature
If cryopreserved

Freezing/thawing process
Freezing medium

Cell recovery & viability after thawing

b) Culture conditions

i) Cell number

The total number of cells put into culture

ii) Cell concentration

The number of cells per ml of medium at start of culture

iii) Culture medium

Type(s) of medium
Source(s)

Additives (excluding diff/tol agents)

Source(s)

Refreshment of the medium

iv) Culture container

Type of container
Size

Manufacturer

Cell culture volume per container or well
Total number of containers or wells

must

should

may

v) Culture environment

Temperature and C02 concentration
Use of pre-warmed medium
Equipment

c) Differentiation/induction of tolerogenicity (diff/tol) protocol

Protocol

Name of cytokine(s) or other agent(s) used
Source

Concentration

Time-point(s) added to cell culture
Total length of the culture period

d) Antigen

Name

Source

Concentration

Time point(s) added to culture
Carrier (if applicable)

e) Storage

Storage time
Storage conditions
If fresh

Fluid

Container
Temperature
If cryopreserved

Freezing/thawing process
Freezing medium

Cell recovery & viability after thawing
Time point at which cells are stored if different
to the end of the culture process

3. Cells after

a) Phenotype

i) Morphology

Shape and appearance of cells

ii) Cell surface and intracellular markers

Molecules measured (using CD names)
Methodology

Stimulus and time of stimulation (if applicable)

must

should

may

iii) Secreted molecules

Molecules measured
Methodology

Stimulus and time of stimulation (if applicable)

b) Cell behaviour

Behaviour of cells in a functional assay

c) Cell numbers

i) Absolute cell number

Total number of cells at the end of the isolation process
Methodology

ii) Viability

Percentage of viable cells
Methodology

4. About the protocol

a) Regulatory authority

External authority that approved the protocol
Does protocol follow GMP?

b) Purpose

The reason for manufacturing the cells

c) Relationship between the source organism for the cells
and the target organism

Allogeneic/Autologous/ Xenogeneic/Syngeneic

d) Contact details

Name(s) of the corresponding author(s)

Contact details of the corresponding author(s)