Ensuring the in-use stability of injectable drug products as well as the compatibility with materials for administration is crucial for product quality and patient safety. Despite this importance, there is a lack of clear regulatory guidance on the design of in-use stability and compatibility studies for early phase studies. This forces both manufacturers and healthcare practitioners to adopt a pragmatic approach.
In this webinar, experts from Ardena and DataRevive will provide insights into the regulatory landscape for in-use stability studies of injectables and explore relevant WHO, EMA, FDA, and USP guidelines. This comprehensive overview will be followed by a discussion of the main parameters needed to design IV compatibility and in-use studies suitable for early phase clinical trials. A cross-functional perspective which encompasses clinical aspects, regulatory aspects, and analytics will be provided. The webinar will also cover case studies, providing attendees with practical examples of how to tackle different scenarios.
This webinar will equip participants with a comprehensive understanding of the latest approaches and considerations for designing and executing in-use and compatibility studies for injectables for Phase I and II clinical trials. They will also gain an appreciation of the key regulatory requirements and challenges in this field and learn how to approach different scenarios through case studies. Attendees will acquire practical knowledge to ensure the quality and safety of injectable drugs during administration.
Ms. Retterson has served as site head and general manager at Amgen, Genzyme, and Charles River, where she oversaw manufacturing, QA, QC, process development, and supply chain. The majority of her professional career was spent at Amgen. During her tenure at Amgen, Ms. Retterson held a variety of positions of increasing responsibility, including Site Head of Amgen’s multi-plant Thousand Oaks manufacturing site and VP/GM of Amgen’s Rhode Island Facility.
Over her career, Kathleen has been responsible for the successful manufacture of a number of top biologics including EPOGEN®, Neupogen®, Aranesp®, Neulasta®, Infergen®, Enbrel®, Cerazyme®, Fabrazyme® and Myozyme®.
Kathleen holds an undergraduate degree from Brown University, and a master’s degree from Stanford University.
Dr. Baird is board-certified in Pediatric Hematologist / Oncologist and a subject matter expert in cell and gene therapy regulatory affairs. Dr. Baird has over 18 years of clinical research experience in pediatric oncology at the National Cancer Institute (NCI) in Bethesda, Maryland, US, and 8 years of regulatory experience the in U.S. Food and Drug Administration (FDA) in the role of Medical Officer / Clinical Reviewer, within the Oncology and Hematology Branches in the Office of Tissue and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER). Dr. Baird joined the DataRevive team in September 2022.
Graduated in Biochemistry and Biotechnology and having obtained a PhD in Biomedical Biotechnology, Kelly joined Ardena as a CMC Writer and rapidly grew to Senior CMC Writer. Her role is to provide regulatory advice to clients as well as to write scientific reports and regulatory documentation. Kelly gained extensive experience working on projects for big pharma and combines this with her knowledge on Biotechnology and large molecules.
Stef De Lombaerde, PhD
Group Leader Analytical Development
Stef De Lombaerde graduated as a pharmacist and obtained his PhD in Pharmaceutical Sciences at Ghent University in 2018. Afterwards, he worked as a radiopharmacist at the Antwerp University Hospital, where he gained additional experience in the GMP manufacturing and quality control of sterile preparations for intravenous injection. In 2022, he joined Ardena as a Group Leader Analytical Development, where he is responsible for implementation and validation of analytical methods, coordinating stability studies and QC release testing for various novel drug products (both sterile and non-sterile).