Continuous freeze-drying process
- After the powdered vaccine is dissolved in water (diluent), will it be the same as the original liquid vaccine?
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Recent research has confirmed that certain lyophilized vaccines have the same effectiveness as the original liquid vaccine. However, some other vaccines might not show the same efficacy.
- In short, is this just like freeze-drying?
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Yes, lyophilization and freeze-drying are the same process.
- When can you start producing powder vaccines?
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We would like to receive vaccine samples as soon as possible to start the validation of the process.
- mRNA vaccines may be difficult to reconstitute. Protein-based antibody vaccines should be easier, however, because the diluent used is different, the risk of side effects must be examined.
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Recent research has confirmed that certain lyophilized vaccines have the same effectiveness as the original liquid vaccine. However, we must still investigate the risk of side effects.
- Is water used to dissolve the powdered COVID-19 vaccine before injection?
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No. The vaccine is prepared by dissolution in the diluent provided by the vaccine manufacturer.
- Why does powdering eliminate the need for temperature control?
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Vaccines are unstable in the presence of water and must be stored frozen. Removing water makes them less susceptible to degradation and allows them to be stored without freezing. However, the law stipulates that the temperature used for storage should be indicated by specific numerical values. The standard temperature is 20°C, room temperature is 15-25°C, room temperature is 1-30°C, and cold storage is 1-15°C. We intend to conduct stability tests by the regulations and determine the specific storage temperatures.
- It’s not unusual for a drug or vaccine to be a powder, but your manufacturing process is unique. The problem is that it would take quite a bit of time to verify the efficacy of the powdered vaccine.
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Yes. We would like to receive vaccine samples as soon as possible to begin testing its efficacy and safety.
- It is not clear whether the efficacy of vaccines is impaired by powderization. Also, how is it stored, and with what shelf life?
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Recent research has confirmed that certain lyophilized vaccines have the same effectiveness as the original liquid vaccine. According to regulations, the exact storage conditions and shelf life are finalized after stability studies are concluded.
COVID-19 freeze-dried vaccine that can eliminate the need for cold supply chain possible.
OSAKA, JAPAN March XX, 2021 — Amid a warlike effort around the globe for the development, production, and ultra-cold shipment of COVID-19 vaccines, Morimoto-Pharma, a Japanese company that has technology to freeze dry injectable drugs, is offering a solution. They believe their technology will also work for COVID-19 vaccines. Cold supply chains create a logistical headache and make it more difficult to inoculate people, especially in tropical, remote locations. A powdered freeze-dried vaccine that can be handled, stored, and shipped at room temperature would be a welcome sight.
“We patented the continuous spray freeze-drying equipment and method last October without having vaccines specifically in mind. However, due to the strict cold chain requirements, there is a lot of interest in a COVID-19 freeze-dried vaccine. There have been incidents of freezer malfunctions forcing vaccine to be discarded instead of going to patients. We hope to prevent that,” President Shuji Morimoto said.
The name of their new equipment is the Morimoto-Lyopho TM. Inside, a solution is sprayed from nozzles located at the top and then is frozen into a snow-like powder as it falls. The frozen powder is then automatically transferred into a horizontal vacuum rotary dryer. Temperatures of individual sections of the dryer are monitored and controlled in real-time so that a high-quality dry powder formulation is produced. The powder then must be filled into vials under sterile conditions. Unlike typical shelf style freeze-drying, which is a batch process, the Morimoto process is continuous.
“Compared to the conventional batch freeze-drying of vials, the production capacity is approximately ten times greater. Using our technology, it would be possible to build a two or three production-line factory and produce hundreds of millions of doses per year”, President Morimoto said.
Morimoto Pharma is hoping to contribute by supplying powdered COVID-19 vaccines to people worldwide. They are working with domestic and overseas pharmaceutical companies to further develop their technology.
Morimoto Pharma believes in innovation in design to improve the safety and administration of medication.
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