The increasing incidence of cancer and the ever-rising demand for anticancer drugs results in significant growth for the highly potent active pharmaceutical ingredients (HPAPIs) market. The highly toxic properties of HPAPIs, however, present manufacturing and handling challenges. Our meeting facilitates hands-on experience sharing with focus on early process development and scale up, occupational health regulations and safety standards, cross-contamination risk assessment and control, aseptic facilities and equipment maintenance and cleaning, outsourcing and technology transfer strategies.
08:00 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 GMP and Occupational Safety Requirements for highly potent aseptic processing.
Richard Denk,
Head of Sales Containment, Skan AG, Munich, Germany
09:15 Speed Networking
09:55 Practical Delivery of HPAPI Projects.
Jeremy Justin Mason-Home, BSc (Hons), FRSC,
Director, HPAPI Project Services Limited, Hoylake, United Kingdom
10:30 Best practices: requirements for fully-integrated service-offerings in a HPAPI and cytotoxic environment.
Maurits Janssen, Ph.D.,
Vice President, Head of Commercial Development, API Development & Manufacturing, Lonza AG, Basel, Switzerland
10:55 Morning coffee and networking break
11:25 Risk-based handling of highly potent APIs: cross-contamination and transportation parameters.
Dr. Ildiko Ziegler,
Quality Assurance Manager, Vanessa Research, Hungary
12:00 The Importance of Involving Your People.
Risk assessment is a statutory process that has many benefits. Research shows that involving employees in job based risk assessment has many benefits for any business, not least leading to improved organisational and employee knowledge. In todays brain based economy can organisations afford not to develop the knowledge of their employees?
This session highlights the unseen benefits of listening and involving your employees.
Tim Briggs, MA CFIOSH,
Course Director Health Safety and Environmental Management Courses, Past President IOSH, Leeds Beckett University, Leeds, United Kingdom
12:35 Vacuum Double Drum Dryer For HPAPI’s Production.
Patrick Scanlon,
Global Product Director, Hebeler Process Solutions LLC, New York, USA
13:00 Business lunch
14:00 Single Use Flexible Isolators reduces cleaning and cross contamination risk.
Scott Patterson,
Vice President Pharma/BioPharma Technical Support, ILC Dover, Chicago, USA
14:40 Novel Antibody Drug Conjugate Manufacturing - Synthesis, Conjugation, and Coordination.
Dr. Thomas Nittoli,
Director, R&D Chemistry Therapeutic Proteins, Regeneron Pharmaceuticals, Inc, New York, USA
15:15 Cleaning Validation as one driver to prevent cross-contamination.
Andreas Schreiner,
Director of Validation, Manufacturing Science and Technology, Novartis, Basel, Switzerland
15:50 Afternoon coffee and networking break
16:20 Cleaning Validation for API: Reaching a Steady State.
Michel Crevoisier
Consultant, Formerly Novartis Senior QA and GMP Expert, Formerly Novartis, Basel, Switzerland
16:55 Analytical Approach for Implementation of Visual Inspection.
Visual inspection following equipment cleaning is a mandatory step in the cleaning verification workflow for pharmaceutical equipment. Equipment must pass visual inspection before swab sampling for analysis can be performed. However, since a significant number of low risk compounds are visible well below established safety levels, it is possible to justify equipment as “visually clean” without performing swabbing analysis. Internal studies performed at BMS showed that over 90% of participants could identify residual product at a level of ~2 ppm without preliminary training. The implementation of a robust visual inspection qualification program and clear “Visually Clean” inspection parameters can enable visual inspection to be used to qualify equipment in lieu of swab analysis for low risk products.
Mariann Neverovitch,
Research Scientist, Bristol Myers Squibb, New York, USA
17:30 Roundtable Discussions: The six Whats in safe HPAPI manufacturing.
18:00 Chairman’s closing remarks and end of day one
19:00 Business dinner
08:00 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 Workshop: How to identify high potency and high toxicity and what to do with it.
Ester Lovsin Barle, PhD, MScTox, ERT,
Head Product stewardship and Health, Takeda, Basel, Switzerland
09:40 Exposure Monitoring at the workplace - challenges due to workplaces and the new EN689.
Silke Buechl,
Deputy Managing Director, Occupational hygienist, Praevena AG, Basel, Switzerland
10:15 Morning coffee and networking break
10:45 Chemical Exposure Assessment and Control; the Bayer HPAPI approach.
Kees Hommes,
Global Occupational Hygiene and Safety Manager, Bayer AG, Leverkusen, Germany
11:30 Workshop: Apply the Control Class matrix on a task that potentially results in API exposure and define the needed control class.
Kees Hommes,
Global Occupational Hygiene and Safety Manager, Bayer AG, Leverkusen, Germany
11:55 Analysis of containment testing.
Michael Avraam,
Global Product Manager for ChargePoint PharmaSafe, ChargePoint Technology Ltd, Liverpool, United Kingdom
12:30 Business lunch
13:30 An Ipsen Case Study in Potent Compound Handling.
Mike Whaley,
VP Global EHS, Ipsen, Boston, USA
14:05 Top ten audit findings from HPAPI facilities.
In order to have an effective potent compound safety program, auditing must be performed on a periodic basis. In this session, Dean Calhoun will share the top ten audit findings based decades of professional auditing experience throughout the world.
Dean Calhoun,
CEO, Affygility Solutions, Denver, USA
14:40 OUTSOURCING 4.0: innovative Pharma creates the CMO net.
Enrico Bettetini,
Senior Advisor Associate, Oriento SA, Novara, Italy
15:15 Afternoon coffee and networking break
15:45 Development & Manufacturing Considerations of High Potent Drug Products – a CDMO’s perspective.
Anil Kane, Ph.D., MBA,
Executive Director, Global Head of Technical & Scientific Affairs Pharma Services, Patheon, Part of Thermo Fisher Scientific, Toronto, Canada
16:20 Chairman’s closing remarks and end of summit
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Affygility Solutions - Ardena - ARTeSYN Biosolutions - Bayer AG - Bayer Consumer Care AG - Biocon - Bristol Myers Squibb - Celgene - ChargePoint Technology Ltd - EVER Pharma Jena GmbH - Gedeon Richter - GlaxoSmithKline - Guido Maik Consulting - Hebeler Process Solution LLC - HPAPI Project Services Limited - ILC Dover - Ipsen - JLS International Germany - Krka, d.d., Novo mesto - Leeds Beckett University - Lonza - Lonza Pharma & Biotech - Lusochimica SpA - Merck Group - Minaken - Mitsui & Co. Italia S.P.A. - MSD - Novartis - Novasep - Oriento SA - Patheon, part of Thermo Fisher Scientific - Piramal Pharma Solutions - Pliva Croatia Ltd, TAPI Croatia - Praevena AG - Regeneron Pharmaceuticals, Inc - Skan AG - Takeda Ireland Limited - Umicore AG & Co KG - Others