ISPE Congress on Innovation
Innovations in Process Technology for Manufacture of APIs and BPCs
10 - 11 April
Seminar Leaders:Rick McCabe, Pfizer, USA
Pierre Le Meur, SPEC Conseils, France
Description:
Innovations in process technologies for batch and continuous processing promise to dramatically change the manufacture of APIs, improving process capability, product quality parameters, waste reduction, and cost reduction.The seminar is focused around ISPE Baseline® Guide: Active Pharmaceutical Ingredients (a revision of the Bulk Pharmaceutical Chemical Facilities), and will identify the key concepts outlined in the Guide, a structured approach to full process design and systems, regulation, and technological innovations,
and – through case studies from the “Brightest” Consortium – identify real solutions to the challenges associated with implementing new process technology, and continuous processes in API and BPC manufacture.
Take Back to Your Job:
- An understanding of the impact of process technology and continuous processes in API/BPC manufacture
- Knowledge of new and emerging process technologies, equipment design considerations, unit operations and the factors involved in implementing continuous processes
- Ways to identify and overcome the quality systems challenges in implementing new process technologies
Agenda:
Thursday, 10 April
| 10.00 – 10.15 | Welcome and Introduction Pierre Le Meur, SPEC Conseils, France |
| 10.15 – 11.00 | Implementation of a Continuous Process - Understanding the factors involved Huw Thomas, Foster Wheeler, UK • Continuous Process Development - Business Drivers, Process Lifecyle, Equipment Selection • Continuous Plant Design – Equipment Scale-up, designing for flexibility, integrating Continuous and Batch Plants • Operation of Continuous Plants – Regulatory Aspects, Process Control and PAT, Operational Requirements |
| 11.00 – 11.45 | Process Design Paul Sharratt, Manchester University, UK • Nature of commercial and technical benefits of Continuous Processing • Necessary changes in skill base to access Continuous Processing • Challenges that Continuous Processing presents to organisation and management • Examples of individual Continuous Technologies and whole Continuous Process |
| 11.45 – 12.30 | Challenges in Validation of Continuous Processing Peter McDonnell, Genzyme, USA • Risk management for Continuous Processing • Attaining steady state operation • Use of PAT • Perturbations of the steady state • Accessing Regulatory relief post-submission |
| 12.30 – 14.00 | Lunch |
| 14.00 – 14.45 | Continuous Manufacturing: The Ultra Lean Way of Manufacturing Walter Bisson, Novartis, Switzerland • Pros & cons of Batch Manufacturing • Blue sky vision of Continuous Manufacturing • Expected benefits of Continuous Manufacturing • Integration of Equipment Manufacturer into the Innovation Cycle |
| 14.45 – 15.30 | API Process Technology – Improving the Productivity of the Manufacturing Process Sarah Mancini, Pfizer, USA • Process Selection and Design • Technology Development Facilities • Overview of Key Technologies being applied at Pfizer • Challenges associated with the implementation of New Process Technology and Continuous Processes |
| 15.30 – 16.00 | Coffee Break |
| 16.00 – 16.45 | New Technologies for Safe and Contained Powder Handling in the Bulk Pharmaceutical Industry Frederic Dietrich, Dietrich Engineering Consultants, Switzerland • Comparison between traditional operation and new Powder Handling Technologies • Increase of productivity and decrease of process downtime (faster product changes for multipurpose operation) • Improvement of processes by changing from Batch to Semi-continuous Operation |
| 16.45 – 17.30 | Batch Reactor Innovations Jean-Marie Eslinger, De Dietrich, France • Advantages and restrictions of Glass-lined Reactors • Improvements in Glass-lining Technology • Application of new Technologies and Products to improve the effectiveness of Cleaning and Cleaning Validation |
| 17.30 – 18.00 | Questions & Answers Chairman’s Day 1 Close Rick McCabe, Pfizer, USA; Pierre Le Meur, SPECS Conseils, France |
| 18.00 – 18.30 | Networking Reception |
Friday, 11 April
| 09.00 – 09.15 | Recap of Day 1, Introduction of Day 2 Rick McCabe, Pfizer, USA |
| 09.15 – 10.00 | Continuous Crystallisation Using Oscillatory Baffled Crystalliser Xiong-Wei Ni, Nitech Solutions Ltd, UK • Introduction to Continuous Oscillatory Baffled Crystalliser (COBC) • Radial Mixing • Heat Transfer Coefficient • Benefits of COBC through industrial examples |
| 10.00 – 10.30 | Coffee Break |
| 10.30 – 11.15 | Innovative Blending and Drying Technology Jean-Francois Demeyre, Triaprocess, France • Introduction to Blending in Process Technology • Overview of the Triaxe technology • Triaxe benefits in different application fields |
| 11.15 – 12.00 | ISPE Baseline® Guide & API Community of Practice (COP) John Nichols, Retired, UK • Understand how your COP enables inputs to the ASTM standards • Hear about the new COP Process Technology Subgroup, its current work and its aims • Hear how you can help make a paradigm shift in the API industry's application of new innovative Process Technology • What the API COP has been doing, in education sessions, in testing with a representative case study, the new concepts in the latest edition API Baseline Guide |
| 12.00 – 14.00 | Lunch |
| 14.00 – 15.00 | Regulatory – ASTM Trevor Page, Niro Pharma Systems, UK • Why Continuous Processing • What are the perceived barriers to the introduction of Continuous Processing for pharmaceutical manufacturing • Review of draft guidance under development within ASTM committee E55 |
| 15.00 – 16.00 |
Roundtable Q & A |
| 16.00 – 16.15 | Questions & Answers Chairman’s Seminar close Rick McCabe, Pfizer, USA Pierre Le Meur, SPECS Conseils, France |