company’s first efforts at scaling up the formulation and process capabilities of the drug. Whereas research at MIT/Harvard and initial efforts at BIND were conducted on nanoparticle batches prepared on the bench-top milligram scale, BIND nanoparticle production batch size has been scaled up three orders of magnitude for the animal safety and tolerability tests that support clinical studies.
The critical, long-term stage of pharmaceutical development is clinical testing. Through a progression of studies, the safety, tolerability, and efficacy of a drug product candidate are established; the tests are accompanied by a series of submissions to and discussions with the FDA.
For BIND targeted polymeric nanotherapeutic drug candidates based on improving the performance of existing marketed drugs, the clinical testing period is likely to be shorter than for a completely new drug candidate, because the history and data established for the existing drug provide valuable reference points for BIND and the FDA. Nevertheless, several clinical studies are required, all CMC requirements must be met, and the nanoparticle production process must be scaled up to the kilogram level to supply the drug for clinical studies and ultimately, if successful, to supply the approved, marketed drug to doctors and patients.
Thus a long, challenging, very exciting pathway lies ahead for BIND Biosciences in translating the novel targeted polymeric nanoparticle drug-delivery research by Professors Langer and Farokhzad into medicines that can improve, and even save, the lives of patients suffering from serious diseases.
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