Release and labeling of fetal precursor cell transplants

From FETAL PRECURSOR CELL TRANSPLANTATION (FPCT)
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Before the release of a batch of fetal precursor cell transplants all documentation about manufacturing is checked by the quality control unit, especially the description of :

- all steps of manufacturing process;

- all components, supplies, containers, closures, labels, used in manufacturing;

- all post-manufacture testing and sampling, including storage of the last supernatant of each tissue culture flask, and

- any &all other data required by GMP,

all such documents must be signed by the supervising tissue culture expert, and co-signed by the manager.


On the batch release date, each transportation vial contains the full treatment dose of fetal precursor cell transplants of one organ or tissue of the batch ("strength"), labeled with:

a/ a name of fetal cell transplant,

b/ the patient's code, (a + b = ‘identification’),

c/ the number of the batch, and

d/ the number of a fetal precursor cell transplant, which number is linked to all newborn and fetal rabbits used in its preparation via the identification number of all rabbit females, the sources of all fetuses / newborns used, (‘purity’), and to the records of the entire manufacturing process, histological and bacteriological testing, test for bacterial endotoxins, and other quality control unit data (‘quality’).


All labelled vials of the batch are packed in the transportation box, on the top of which a final label is placed. Transportation box is then placed in a thermostatic container for a transportation by a currier for an implantation within the next 48 hours.


Labels placed on a box containing a batch of fetal precursor cell transplants to be used for the treatment of a specific named patient on the pre-determined date of implantation include the following data:

a/ Name and address of laboratory that prepared a batch of fetal precursor cell xeno-transplants;

b/ Names of each fetal precursor cell transplant in the batch, that state from which organ or tissue each cell transplant originates;

c/ Batch number;

d/ Patient’s code;

e/ Identification codes of each cell transplant in the batch;

f/ Volume of each cell transplant of the batch - ‘dosage’;

g/ Description of supernatant;

h/ Release date;

i/ Statement: “Expiration date: 4 days from the release date, if maintained at room temperature at all times, but implantation within 48 hours strongly advised!”

j/ Statement: “Recommended storage temperature: 20? C”

k/ Statement: “Live cultured tissue fragments! NO PRESERVATIVES USED!”

l/ Statement: “Route of administration: implantation by specialized injection techniques as per enclosed instructions”;

m/ Statement: “HANDED TO THE PATIENT’S PHYSICIAN ONLY!”


The data on lines a/, b/, c/, d/, e/ appear also on the label of the vial of each fetal precursor cell transplant of the batch.

a/ Name and address of laboratory that prepared a batch of cell xeno-transplants;

b/ Name of the actual fetal precursor cell transplant in the vial, that states from which organ or tissue the cell transplant originates;

c/ Batch number;

d/ Patient’s code;

e/ Identification code of the actual fetal precursor cell transplant in the vial.


A delivered batch of fetal cell transplants is accompanied by the instructions about implantation sites for each fetal precursor cell transplants.