Decreasing the Time from Antibody Idea to IND Approval

Decreasing the Time from Antibody Idea to IND Approval


In 2015, Ram Sasisekharan, PhD, the Alfred H. Caspary professor of biological engineering and health sciences & technology at MIT, founded Tychan. The company concentrates on one key goal: decreasing the time from antibody idea to investigational new drug (IND) approval. Now, the company claims it can cut the average time in half and more.

“With traditional technology, it usually takes about 18 months to get an antibody into human trials, from discovery to development,” Sasisekharan said. “For the Zika and Yellow Fever viruses, we developed new antibodies that went into human trials in less than nine months.” This new speed arises from a combination of informatics and bioprocessing.

“As for antibody engineering, we use computational methods to target functionally important, and evolutionarily stable, regions on the virus,” Sasisekharan explained, “and our bioprocessing method makes antibodies in a matter of weeks, instead of the many months usually required if working with a master cell bank. We showed there is no difference between the antibodies from the traditional approach and our technique.”

To achieve these speeds from idea to in-human trials, it takes more than an improvement in one step. Tychan takes a broad view of how to work faster. According to Tychan’s website: “We use convergent analytics to define molecular fingerprints for reliable tracking of safety and potency of biologics throughout the manufacturing process—from cell selection to final product.” At any speed, a bioprocess needs to meet many constraints and follow specific rules. “We actually were data rich for our regulatory filings to demonstrate feasibility,” Sasisekharan said. “We followed the regulatory guidelines.”

Sasisekharan noted that similar technology could be aimed at COVID-19. Taking Tychan’s approach to developing viral treatments in general, Sasisekharan said: “This is not a theory, because we’ve done it.” Lots of people around the world are hoping that Sasisekharan and his team can do it again, and fast.

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