Benefits & Challenges In a Highly Potent Landscape
Although the concept of Quality by Design (QbD) has existed for almost 10 years due to ICHQ8(R1) being released for public consultation on November 1st, 2007, it has still not been as widely embraced by the industry as expected, especially in a time when the authorities’ concerns about inadequate quality are getting ever more pronounced while reviewing new drug applications or inspecting manufacturing sites. Although many companies have by now adopted the QbD concept to a certain degree, some are still struggling to evaluate the costs versus benefits of this new paradigm for the development and production of drug products.
Quality by Design is not simply a set of tools which can or cannot be applied during drug development, but rather a strategic philosophy of how companies approach an entire drug development program, including decisions on what to investigate, how to link investigations to Critical Quality Attributes (CQA), and their effects on safety, efficacy and compliance of drug products for the patient. Dr. Iris Ziegler, Director of Pharmaceutical Sciences & QbD at CordenPharma International, will outline the basic parameters of how to implement such a QbD philosophy, and why this is an essential prerequisite for the successful roll-out of a QbD drug development plan.
"Only when integrating a QbD-driven approach throughout the complete organization, including their systems, can a company fully benefit from the advantages and savings of QbD developmentâ€ comments Dr. Ziegler, while explaining how even a small Contract Development and Manufacturing Organization (CDMO) can afford QbD and even generate a competitive advantage by doing so.
Dr. Ziegler will also share her expertise in QbD for the development of drug products with Highly Potent Active Pharmaceutical Ingredients (HPAPIs), such as OEB4 and OEB5 compounds, which require a high degree of containment. In this specialized area of drug development, the benefits of implementing a QbD approach at the earliest possible point in the development plan are most prominently visible. Topics to be covered include:
- Applying QbD principles for Highly Potent compounds throughout early development, including feasibility studies – and not just during late-stage Phase IIb or III development
- Present a case study which demonstrates the benefits arising from holistic adoption of the QbD mindset
- What if the customer does not want QbD?
QbD-driven development incorporates a risk-based and scientific approach from the start. It requires continuous learning / improvement throughout the development cycle, combined with modern manufacturing technologies and a mechanistic understanding of how the desired product quality will be achieved. When implemented thoroughly, Quality by Design really does help reduce development timelines and required API quantities while increasing overall success rates, and thus time to market. The drug development industry still needs to fully embrace QbD - and this still requires a paradigm shift in many companies to finally take place.
Iris M. Ziegler, Ph.D.,
Director, Pharmaceutical Sciences & QbD, CordenPharma International
Dr. Ziegler is a pharmacist with a Ph.D in Pharmaceutical Technology from the University of Munich, as well as an MBA from the Business School St. Gallen. She has worked in the pharmaceutical industry for more than 20 years and is a known expert in the areas of solid dosage forms, drug delivery technologies, and Quality by Design. In her MBA thesis she established the benefits of QbD as a competitive advantage for the positioning of a contract development organisation.
In her various prior positions as group head at Gruenenthal in Aachen, Director of Pharmaceutical Development at Nycomed in Konstanz and Director of Development, Production, Business Development and Project Management at CordenPharma Plankstadt, she has overseen the development, filing and launch of several drug products and been responsible for the strategic positioning of CordenPharma Plankstadt as a leader in the segment of drug product development of highly potent APIs.
In her latest role as Director, Pharmaceutical Sciences & QbD, Iris has actively been involved in the implementation and roll-out of QbD from as early as 2006, and succeeded in a top-down implementation of QbD in Development at Nycomed for all development sites and the overall integration of a QbD driven approach at CordenPharma Plankstadt.