Case Study

How Successful Tech Transfer Can Help Fast-Track NDA Approval

Source: Syngene International Ltd.

A leading US-based biotechnology company needed a long-term partner to manufacture phase-3 batches of its new drug product—which targeted difficult-to-treat infections that are becoming increasingly drug-resistant—and take up commercial manufacturing at a later stage. The drug was a novel compound which used an innovative mechanism to treat severe infections. Syngene’s successful regulatory track record of 28 years, during which Syngene cleared a host of global regulatory audits, was a major factor in the partnering decision.

Syngene ensured 100% first-time-right technology transfer by designing the right set of experiments and manufacturing a limited number of batches of the drug, ultimately securing NDA approval in less than two years from the date of technology transfer. Using an in-depth risk assessment and control strategy, Syngene successfully transferred the manufacturing process for the drug by mapping the critical process parameters and devising an appropriate control strategy. Syngene’s extended capabilities also enabled the biotech to continue with GMP manufacturing for commercialization, and Syngene’s advanced development solutions are opening avenues for injectable formulation to treat severe infections. Examine the first-time-right tech transfer process which led to NDA approval for the novel compound followed by a successful commercial manufacturing process.

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