Table 3.

Quantitative and semi-quantitative results of the lyophilized progenitor cell derivative API (i.e., whole cell lyophilizates) long-term stability studies. The vials were stored in the specified conditions, protected from the light following manufacture, and were equilibrated at ambient temperature overnight before the assessments and the measurements were performed. The characterization was performed using the methods described or referenced in Table 2. The descriptive parameter evaluation was performed by two experienced operators and the semi-quantitative grading was performed using the abbreviated nomenclature presented hereafter. (–) = gross deterioration of the cake, (+) = observable modifications of the cake, (++) = minimal observable modifications of the cake, (+++) = no observable modifications of the cake. The measurements were performed with n = 5. API, active pharmaceutical ingredient.

Storage Period	Storage Temperature	Descriptive Parameters 1	Endpoint Moisture Level	Endpoint Reconstitution Time	Endpoint pH Value
3 months	−20 °C	+++	3.9% ± 0.5%	45 s	7.1 ± 0.2
	4 °C	+++	4.6% ± 0.4%	35 s	7.1 ± 0.3
	22 °C	+++	4.5% ± 0.3%	35 s	7.2 ± 0.3
	37 °C	+++	4.3% ± 0.5%	50 s	7.1 ± 0.4
6 months	−20 °C	+++	4.2% ± 0.3%	45 s	7.0 ± 0.2
	4 °C	++	4.4% ± 0.3%	45 s	7.1 ± 0.1
	22 °C	+++	4.3% ± 0.5%	40 s	7.3 ± 0.2
	37 °C	+++	4.5% ± 0.4%	50 s	7.2 ± 0.3
9 months	−20 °C	+++	4.0% ± 0.1%	45 s	7.1 ± 0.3
	4 °C	+++	4.5% ± 0.5%	40 s	7.1 ± 0.3
	22 °C	++	4.4% ± 0.4%	35 s	7.2 ± 0.1
	37 °C	+++	4.5% ± 0.3%	45 s	7.2 ± 0.3

¹ The gradings of the descriptive parameters corresponded to the addition and the semi-quantitative result ponderation of all the organoleptic and descriptive assays listed in Table 2.