Patented and patent-pending formulation processes and simple mixtures which stabilize the vaccine or bio-therapeutic at up to 40°C as if it were frozen at -80°C.
PT120-D ™Formulation Stabilization Technology
The work on PT120-D started in the Filipe lab at McMaster University in 2014. During the course of this work, many different viruses and vaccines have been stabilized. Elarex has furthered the development by tuning the proprietary formulation to use only inexpensive, safe excipients that are on the FDA GRAS list, and by modifying the process to use commercially available equipment, to achieve a much higher level of stability.
Below are a few examples of different viruses and viral vectors that have been stabilized by PT120-D.
Figure 1. HSV-2 Virus Stability at 25°C. Elarex PT120-D outperforms Trehalose 1000-fold at 12 weeks.
Figure 2. HSV-2 with Elarex PT120-D stored for 8 weeks at 40°C equivalent to storage at -80°C.
Live Attenuated Virus
In the study below, attenuated herpes simplex virus was stored in PT120-D and also in solution at -80°C and 40°C for 12 weeks. They were then used to inoculate mice and these mice were subsequently challenged with the live virus. The results show clearly that protection by PT120-D at 40°C, was as effective as freezing the vaccine at -80°C. The vaccine stored in solution at 40°C was also completely ineffective at protecting the mice.
Live Attenuated Virus
In the study below, attenuated herpes simplex virus was stored in PT120-D and also in solution at -80°C and 40°C for 12 weeks. They were then used to inoculate mice and these mice were subsequently challenged with the live virus. The results show clearly that protection by PT120-D at 40°C, was as effective as freezing the vaccine at -80°C. The vaccine stored in solution at 40°C was also completely ineffective at protecting the mice.
Figure 1. HSV-2 Virus Stability at 25°C. Elarex PT120-D outperforms Trehalose 1000-fold at 12 weeks.
Figure 2. HSV-2 with Elarex PT120-D stored for 8 weeks at 40°C equivalent to storage at -80°C.
Inactivated Virus
In a similar study, inactivated influenza A virus was given to mice who were then challenged with live flu virus. The inactivated virus was stored in PT120-D, which proved to protect it as well as -80°C freezing did. Virus that was stored at 40°C offered no protection.
Figure 3. Inactivated IAV with Elarex PT120-D stored for 12 weeks at 40°C equivalent to storage at -80°C.
Figure 4. Immune response by ELISA for flu-specific IgG in serum. Equivalent responses for inactivated IAV stored at -80°C and when protected by PT120-D at 40°C for 12 weeks.
Inactivated Virus
In a similar study, inactivated influenza A virus was given to mice who were then challenged with live flu virus. The inactivated virus was stored in PT120-D, which proved to protect it as well as -80°C freezing did. Virus that was stored at 40°C offered no protection.
Figure 3. Inactivated IAV with Elarex PT120-D stored for 12 weeks at 40°C equivalent to storage at -80°C.
Figure 4. Immune response by ELISA for flu-specific IgG in serum. Equivalent responses for inactivated IAV stored at -80°C and when protected by PT120-D at 40°C for 12 weeks.
Figure 5. Adenovirus vector, in PT120-D, stored at 55°C. Less than 0.1 log loss due to drying process and less than 0.6 log loss of original titre after drying process and storage at 55°C for 49 days.
Figure 6. Adenovirus stability at 37°C in PT120-D is even more impressive. About 0.25 log loss of original titre after drying process and storage at 37°C for 450 days.
Adenovirus Platform
Adenovirus is a proven viral vector and was instrumental in delivering vaccines quickly for the COVID-19 pandemic and remains a key tool in addressing emerging threats.
We have been able to exceed the best stability data published to date using our proprietary approach to drying.
Adenovirus Platform
Adenovirus is a proven viral vector and was instrumental in delivering vaccines quickly for the COVID-19 pandemic and remains a key tool in addressing emerging threats.
We have been able to exceed the best stability data published to date using our proprietary approach to drying.
Figure 5. Adenovirus vector, in PT120-D, stored at 55°C. Less than 0.1 log loss due to drying process and less than 0.6 log loss of original titre after drying process and storage at 55°C for 49 days.
Figure 6. Adenovirus stability at 37°C in PT120-D is even more impressive. About 0.25 log loss of original titre after drying process and storage at 37°C for 450 days.
Vesiculovirus Platform
VSV is a very promising viral vector that has been critical in the response to ebolavirus outbreaks. VSV is inexpensive to produce, fast growing and easily retargetable. The main downside of VSV is the temperature stability. It degrades quickly above 0°C.
We have found a way to stabilize this amazing vaccine platform so that it is stable for much longer.
Figure 7. VSV vector in PT120-D and in Control formulation, dried and stored for 32 weeks at 37°C. The vector in the control formulation is completely gone in less than a week, while the PT120-D formulated VSV loses about 3 logs in 32 weeks.
Figure 8. When the VSV vector is formulated with PT120-D and stored at 4°C, less than 2 logs of the virus is lost after 32 weeks. This represents a significant improvement over any other formulation and storage practices used in the industry today.
Vesiculovirus Platform
VSV is a very promising viral vector that has been critical in the response to ebolavirus outbreaks. VSV is inexpensive to produce, fast growing and easily retargetable. The main downside of VSV is the temperature stability. It degrades quickly above 0°C.
We have found a way to stabilize this amazing vaccine platform so that it is stable for much longer.
Figure 7. VSV vector in PT120-D and in Control formulation, dried and stored for 32 weeks at 37°C. The vector in the control formulation is completely gone in less than a week, while the PT120-D formulated VSV loses about 3 logs in 32 weeks.
Figure 8. When the VSV vector is formulated with PT120-D and stored at 4°C, less than 2 logs of the virus is lost after 32 weeks. This represents a significant improvement over any other formulation and storage practices used in the industry today.