There is a new way of storage and transportation of biopharmaceuticals "non-cold chain"
Many biological drugs represented by the new crown vaccine have extremely stringent requirements for transportation and storage conditions. How to safely and effectively solve the "non-cold chain" storage and transportation problem is an important topic that has always been concerned in the field.
Recently, a result of the “Molecular Armor” student entrepreneurial team of the School of Pharmacy of Nankai University provides a new strategy for solving this problem.
Under the guidance of the mentor, the team members have developed a new type of biopharmaceutical protection and storage technology with high safety and low cost, which can replace low-temperature storage and transportation and provide a new way for biopharmaceutical storage and transportation.
According to Qiao Shan, the State Key Laboratory of Medicinal Chemical Biology and the Student Entrepreneurship Team of the School of Pharmacy of Nankai University, the leader of the "Molecular Armor" team and the 2021 PhD student in the School of Pharmacy, biological preparations have shortcomings such as poor stability.
They need to be placed in a special "small refrigerator" for storage and transportation, otherwise they are easily affected by external environments such as temperature, pH, and pressure and become invalid.
Therefore, in its transportation and storage process, cold chain processing or addition of stabilizers is required, which leads to greatly increased production costs and potential safety hazards.
"Therefore, we urgently need new biopharmaceuticals to effectively protect biopharmaceuticals, thereby enhancing their ability to resist external environmental influences." Qiao Shan said.
The team's research found that under certain mild synthesis conditions, biomolecules can be wrapped in new crystalline materials in a one-step process.
The wrapping of this new type of crystalline material is like putting on armor for biomolecules, protecting them from the external environment.
Compared with traditional inorganic porous materials, the new crystalline materials have larger porosity and specific surface area, especially with adjustable pore size and variable functional groups.
Qiao Shan and team members creatively combined new crystalline materials with biological drugs such as antibodies and vaccines, and "wrapped" polyclonal antibodies and the widely marketed monoclonal antibody drugs (adam). Through repeated tests, Finally, a new crystalline material protection strategy suitable for biopharmaceuticals was screened, and the safety and protection performance of the new strategy were tested in various aspects.
The results show that under simulated extreme environmental conditions, the protected drug still maintains its structure and activity: under heating, acid-base, organic solvent, pressure and other tests, the biological drug maintains nearly 90% of its biological activity; When stored for 2 months in a continuously changing temperature environment of 4 degrees Celsius to 50 degrees Celsius, the biological medicine still maintains its activity.
This experimental result confirms the great potential of the new strategy developed by the team in the long-term storage and transportation of biological agents at room temperature.
It is worth mentioning that the ingenuity of this strategy is that the new crystalline material protective shell-"molecular armor" can be completely removed in an extremely simple way before the use of biological drugs, and will not enter the human body with the drugs. In addition to traditional stabilizers, the use of "molecular armor" greatly improves the safety of new biological agents.
Qiao Shan introduced that the application of this achievement may provide a new way for the preparation, storage, transportation and use of other biological agents such as antibody drugs and vaccines, and pave the way for the development of new portable biological agent dosage forms.
"If we can get rid of the entire cold chain, it will greatly reduce the production, transportation and use costs of vaccines and other biological agents, and at the same time, it can greatly expand the scope of use of biological agents. This is suitable for remote areas and extreme situations such as disasters and battlefields. The use of preparations provides new possibilities." Qiao Shan said.
Author: Our reporter Liu Qian Chen Jianqiang Our correspondent Fu Kun