As the number and types of therapeutic protein and peptide drugs for treating a growing list of ailments continue to proliferate, the pharmaceutical industry and the drug development processes at its core are evolving. The sequential process of qualifying a drug candidate, obtaining regulatory approval and deciding on packaging and dosing choices has given way to what might be called a ‘wholistic’ approach to drug development, one where concepts like ‘ease-of-use’ and ‘concurrent engineering’ – terms formerly reserved for industrial design and manufacturing – have taken their place alongside long-standing drug development activities such as solubility testing and pre-clinical development.
Biological drugs are currently delivered almost exclusively via injection or infusion. A limitation of the parenteral route for delivery of peptides and proteins is the extremely short half-lives of these drugs. This demands repeated administration, which is inconvenient to the patient and increases safety risks. For this reason, non-parenteral routes of administration are being pursued. Another approach is to incorporate controlled release parenteral formulations, where a single injection may release the drug over several weeks or longer.
Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones and other biological drugs also increase the need for safety and compliance. As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of drug therapies in non-traditional settings for a number of conditions.
These trends are creating an increased interest in formulations and routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that new drug product success no longer only depends on the medication itself but also on achieving a patient-friendly form of administration.
More information on technologies for therapeutic proteins can be found in a new and comprehensive report, researched and prepared by Greystone Research Associates. Therapeutic Proteins to 2016: Drugs, Devices, Diseases, Markets and Forecasts provides comprehensive assessments of therapeutic protein delivery technologies in eight major therapeutic segments, and includes industry data and forecasts, profiles of market sector participants, and detailed analysis of strategic and economic factors.
More information is available at greystoneassociates.org/.