eBook: Alternative Delivery of Biologics — Underdogs Pursue Roads Less Traveled


A number of failures in development of noninjectable delivery methods for therapeutic proteins have caused numerous development programs to crash and burn along with investors’ hopes, dreams, and cash. Most everyone reading BioProcess International is familiar with the issues and challenges: Needles hurt and involve risks to both caregivers and patients. Injections often require administration by trained personnel in specialized settings. But alternative delivery methods are fraught with greater challenges related to dosing, bioavailability (particularly for oral dosing), and inherent difficulties in formulating fragile protein drugs. Alongside human and ergonomic factors, these issues put the industry into (as Oliver Hardy might have said) “a fine mess” that has defied the efforts of the best engineers in the business.

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