International Conference and Expo on Parenterals & Injectables August 17-19, 2015 Chicago, USA

Biography:

Diane Paskiet has over twenty years of experience in packaging analysis. She has served as a project advisor in support of qualifi cation studies associated withrndrug containment systems for regulatory fi lings. Her current responsibilities include coordination of study plans for technical support of packaging componentsrnand R&D. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is serving a five year term on the United StatesrnPharmacopeia (USP) Packaging, Storage and Distribution Expert Committee and a co-recipient of the USP award for Innovative Response to a Public HealthrnChallenge. She is Chair of the PQRI Parenteral and Ophthalmic Drug Product (PODP) Leachables and Extractables Working Group and a faculty member of thernPDA Training Institute, as well as author/co-author of papers on the subject of pharmaceutical packaging.

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.

 

Biography:

Bill Hartzel is the Director of Strategic Execution at Catalent Pharma Solutions, a global leader in development solutions and advanced drug delivery technologies.rnIn this role, he is responsible for the implementation of a full suite of advanced aseptic processing solutions for biologic and complex pharmaceutical liquid products.rnHe provides a strong background in advanced aseptic processing in blow/fi ll/seal and plastics in which he has numerous publications and presentations on therntopics. Additionally, he has been a leader in the single use “disposables” industry since 2006 for his background in materials of construction. He is on the Board ofrnDirectors for BPSA, a Technical Author for PDA –TR 66 on Single Use Manufacturing, and the former Chairman of the ASME BPE Task Group for Single Use. Hernhas an undergraduate degree in Chemical Engineering and an MBA from Villanova University.

Abstract:

This presentation will focus on the use of the advanced aseptic fi lling techniques utilized in blow/fi ll/seal technology torncreate a glass-free injectable platform for biologics. It will provide details on how the principles of QbD are leveraged inrnthe equipment and process design to dramatically reduce the risk profi le and particulate contamination in parenteral fi llingrnthrough control and automation. In addition, the presentation will provide a case study of a model mAb and its compatibilityrnwith the BFS vial compared to glass.