Diane Paskiet
West Pharmaceutical Services, USA
Title: Perspective on Challenges Facing Injectable Products
Biography
Biography: Diane Paskiet
Abstract
The outlook for sterile injectable products continues to expand as do the many challenges facing pharmaceutical manufactures.rnResearch and development eff orts are now focused on patient centric therapies and the quality of medicines will bernjudged accordingly. Infl uencing factors include the drive to lower medical costs by enabling at-home self administration andrnpromoting adherence with delivery devices designed to meet patient needs. In addition, approvals of biologics are on the risernand being facilitated by FDA expedited approval pathways for novel drugs. Th e injectable route of administration is commonrnto many biologics which contributes to the increased need for qualifi ed delivery system. A key consideration during drugrnproduct development is the interaction between multiple components that will collectively aff ect performance and quality ofrnthe fi nal product. Building quality into drug products also includes effi cient manufacturing capabilities. Th e lack of scientifi crnunderstanding and inadequate manufacturing controls has led to shortages according to FDA. Combined challenges arernlinked to qualifying components, processing and fi lling, complex supply chains, and evolving globalization. Th ese variablesrncan generate an abundance of risked factors which can result in long development times, product recalls, and shortages ofrnlifesaving medicines. Risk management and quality by design (QbD) paradigms have become the standard approach forrndrug development but the fact remains that therapies can only be eff ective if the medicine can be successfully delivered tornthe patient. Integral to the drug product are the protection of medicines and safe delivery to the patient, which are essentialrnelements for achieving positive outcomes. Th e progression of the QbD paradigm should bring together drug developmentrnand manufacture with containment and delivery systems. Th ese concepts can be applicable to the fi nal drug product and itsrncritical material attributes, such as components of delivery systems. A comprehensive science based program for product andrnprocess understanding will allow effi cient manufacture of quality products to be safely delivered to the patient.