Table 3

Results of preliminary stability studies

Description

Limits

2-8oC

40oC


0

3

6

12

1

3

6


Particle size (light microscopy)

≥ 60% of under 50 µm

S

-

S

S

NP

NP

NP


Shape (light microscopy)

elongated tubular structures

S

-

-

S

NP

NP

NP


pH

7±0.5

7,4

7,1

7,1

7,1

7,2

7,2

7,3


Appearance

Milky suspension

S

S

S

S

S

S

S


Free Ca2+ (atomic absorption)

<5 mM

<0,1

<0,1

NP

<0,1

-

<0,1

<0,3


Protein concentration (Lowry)

1,2±0,2 mg/mL

1,19

1,26

NP

1,27

1,19

1,2

1,26


Preservative (atomic absorption)

0.07-0.13 mg/mL

0.1

NP

NP

0,09

NP

NP

NP


Identity (SDS/PAGE)

two majority bands between 36 and 46 kDa and two minor between 70 and 85 kDa

P

P

NP

P

P

P

P


Microbial limit

Less than <102 aerobic bacteria or fungi by Pseudomonas aeruginosam. Absence of Staphylococcus aureus, Escherichia coli and Salmonella

S

S

NP

NP

NP

NP

NP


Preservative

Microbial growth reduction <2 log at 14 days and no microbial growth increased from 14 to 28 days

S

S

NP

S

S

S

S


Potency ELISA(IgA)

IgA in saliva anti OMV > 250 UA

261.33

503

NS

882.17

NS

NS

NS


Potency ELISA(IgG)

IgG in serum anti OMV

S

S

S

S

S

S

S


Legend: S, Satisfactory; NS, Not satisfactory; NP, Not planned; – , Not evaluated or planned; P, Positive

Zayas et al. BMC Immunology 2013 14(Suppl 1):S4   doi:10.1186/1471-2172-14-S1-S4

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