The drugs build from biochemical compounds, known as biologics, manufactured by living organisms, are now commonly used to treat several conditions, such as chronic plaque psoriasis, breast cancer, and rheumatoid arthritis. However, the quality monitoring of these drugs has been a challenge, as the production of protein by living cells is harder to control in comparison to the production of traditional drugs.
The engineers at MIT have developed a new technique to evaluate biologics as they are manufactured. This can result in rapid and more effective safety tests for these drugs. The device, rooted on an array of nanoscale filters, can be adjusted to separate proteins by size as they pass through a small channel. This will enable constant screening as the proteins are manufactured. This size data can disclose whether the proteins have clustered together, which is an indication that the original structure of the protein is lost.
After entering the nanofilter array system, the proteins are headed to one side of the wall. This thin protein lines then comes across an array of slanted filters with 15–30 nm tiny pores. The pores are devised such that smaller proteins will simply fit through them, whereas larger proteins will travel along the slanting for some distance before passing via one of the pores. This facilitates the proteins to be sorted on the basis of their size. The smaller proteins reside closer to the side where they initiated, whereas the larger proteins flow to the opposite side.
The researchers can use this new device to sort proteins spanning in mass from 20 to 100 kDa by altering the pore size. This permits them to verify whether the proteins have created huge clusters that can elicit an unsafe immune reaction in patients. The system was validated by the team with 3 proteins, namely, IFN α2b, a cytokine that is being validated as a cancer drug; human growth hormone; and granulocyte-colony stimulating factor, which is utilized to activate white blood cells production.
To display the potential of the device to determine the degradation of proteins, the team rendered these proteins to destructive conditions such as hydrogen peroxide, ultraviolet light, and heat. Sorting out the proteins via the nanofilter array system enabled the team to precisely verify if they had degraded or not.
Thus, now we have a way to determine the quality of biologics being produced.