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Stability of freeze-dried material during transport

Products produced by Citeq Biologics are stored at -20°C and transport of these products occurs at ambient temperatures. Therefore, long term stability studies are performed at -20°C and short term stability studies are performed at ambient temperature (transport). In this case we have performed a stability study for the cockroach species Blatta orientalis.

Materials & Methods

Transport of Blatta orientalis products occurs at ambient temperature. To demonstrate that transport at ambient temperature has no effect on our products, 2 batches of Blatta orientalis were examined for stability during 4 days transport simulation at ambient temperature (monitored) at our premises. After day 4 all samples were analysed for protein content (Bradford and BCA method), protein pattern (SDS-PAGE (CBB and silver staining)), and potency (Western blotting (using serum)).

Results of stability study

The temperature (red line) was measured from November 15 until 21 as is shown in figure 1. Temperature reached a minimum at 15°C and a maximum at 25°C.

Figure 1. Temperature (red line) for at least 6 consecutive days.

Protein content was determined, for 2 different batches (left and right) of Blatta orientalis, by the method of Bradford and BCA and results are shown in figure 2.

 

 

 

 

 

 

Figure 2. Protein content (Bradford and BCA method) determined for 2 different batches (left and right) at day 1 and day 4.

There is no difference in protein content for both Bradford and BCA method after day 1 and 4 for 2 different batches Blatta orientalis. Data obtained for both protein methods is conform specifications. SDS-PAGE and immunodetection for 2 different batches Blatta orientalis are shown in figures 3 and 4. There is no difference in protein pattern between day 1and 4. Also, no difference is observed in potency between day 1 and 4.

First batch

A

B

C

 

 

 

 

 

 

 

 

 

 

Figure 3. SDS-PAGE for Blatta orientalis batch A) CBB, B) silver staining and C) immunodetection (serum).

Second batch

A

B

C

 

 

 

 

 

 

 

 

 

 

Figure 4. SDS-PAGE for Blatta orientalis batch A) CBB, B) silver staining and C) immunodetection (serum).

Conclusion

Blatta orientalis Whole Bodies, pulverized and Freeze Dried can be transported at ambient temperatures(Figure 1) without loss of protein (Figure 2) and without change in protein pattern (Figures 3A and B, and potency (Figures 3C and 4C).

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