Product and Process Optimization

The Università Degli Studi di Siena, Dipartimento Farmaco Chimico Tecnologico; Societa’ Chimica Italiana, Divisione di Chimica Industriale; Center for Process Analytical Chemistry at the University of Washington, Seattle; and IFPAC have planned an exciting conference on Process and Product Optimization to be held from 5-8 October 2008 at the Certosa di Pontignano in Siena, Italy. Key topics include Quality by Design (QbD) and Process Analytical Technology (PAT) initiatives.

The meeting will serve not only those that are starting to work in these areas, but also to those already seasoned and familiar to these important agency and industry initiatives. There will be plenty of new information for companies that are already involved in PAT, QbD, and related topics.

Europe has a number of the leading PAT/QbD applications in the pharmaceutical industry. Representatives from Wyeth, GSK, Novartis, University of Hull, Redox and University of Parma will discuss several of these applications. Also participating are Moheb M. Nasr, FDA, OPS, ONDQA and Riccardo Luigetti, EMEA.

We have structured the conference to deliver much more than PAT and Quality by Design. We want this conference to be a showcase of challenges and issues in pharmaceutical science, food safety & security, and biotechnology. Additional focus is being placed on the imperative and cutting edge events occurring in nanotechnology, green chemistry, bio-energy, hazard evaluation, and with micro-reactors.

The conference will involve plenary lectures on regulatory aspects, project management, risk management, and a number of QbD applications. There will be talks on technical advances in PAT that will then be discussed to see if they can address some of the challenges highlighted in the plenary talks.

Speaker sessions include:

Monday

• Welcome by Prof. Silvano Focardi, rector of University of Siena
• Introduction describing the challenges and opportunities for product and process optimisation, Mel Koch (CPAC, University of Washington)

Plenary sessions – Chair: Mel Koch

QbD: A global implementation perspective, Moheb M. Nasr (FDA) and Riccardo Luigetti (EMEA)

Hazard evaluation in PAT, Marino Nebuloni (Redox and University of Parma)

• Case studies: Quality by design – QbD – Chair: Graham Cook

QbD Case study I: Using PAT to complement QbD at Wyeth, Graham Cook (Wyeth, UK)

QbD Case Study II: Integrating PAT to support API development at GSK, Vern de Biasi (GSK, UK)

Tuesday

• Plenary sessions – Chair: Mel Koch
• Advances in tools for PAT – Chair: Brian Marquardt

Choice of fiber spectroscopy systems for effective PAT, Artyushenko Viacheslav, (Fibre Photonics)

PAT initiatives extend the range of process MS monitoring of drying processes, from API to finished products and medical devices, Graham Lewis (Ametek, Meerbusch, Germany)

Dynamic surface tension detection: Advances in PAT, Kristen Skogerboe (Seattle University)

Raman Spectroscopy, A useful tool for Process Analytical Technology (PAT), Bruno P. Lenain (Kaiser Optical Europe, Lyon, France)

• Gala Dinner – Siena Town Centre

Date: 5-8 October 2008
Venue: Certosa di Pontignano in Siena, Italy
Website: http://ifpac.com/siena/