Highly Potent APIs Summit 2019

Tentative Schedule:

08:00 Registration and Welcome Coffee

08:30 Opening Address from the Chairman

BLOCK #1 REGULATORY LANDSCAPE

08:40 GMP and Occupational Safety Requirements for highly potent aseptic processing.

• How does GMP and Occupational Safety fit together?
• What are Cross Contamination requirements in shared facilities?
• Cleaning requirements and limits for non-product contact surfaces.

Richard Denk,
Head of Sales Containment, Skan AG, Munich, Germany

09:15 Speed Networking

BLOCK #2 PROCESS ROBUSTNESS, SAFETY & EFFICIENCY

09:55 Practical Delivery of HPAPI Projects.

• Demystifying potent compound project elements
• Connecting hazard and control via risk assessment
• Facility and equipment design – getting the big stuff right
• Understanding and managing uncertainty
• Practical steps for protecting workers and products

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.

• Drug product development based on potent compounds can be quite challenging.
• Complications with the interface between operations in drug substance and drug product handling can also result in increased program complexity and cost.
• In this presentation, we will elaborate on best practices and infrastructure requirements that facilitate accelerated timelines to clinic and market:
• Development, rapid scaling and commercial production of HPAPI drug substance
• Integrated containment requirements for particle engineering and drug products
• Impact of supporting integrated service-offerings on expansion strategies

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.

• Guidelines regarding Quality Risk Management
• Case study 1: technical aspects and complexity in cross contamination risk analysis
• Case study 2: temperature deviation during transportation

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.

• Introduction of single use flexible isolators and containment performance Ergonomic benefits when using flexible isolators and other single use technology Disposal of the single use vs. cleaning - risk reduction Disposal of the single use vs. cleaning - cost reduction.
• Using a single use flexible isolator provides cost savings and reduces risk of cross contamination from retention. This is very important with HPAPI and cleaning limits being reduced.

Scott Patterson,
Vice President Pharma/BioPharma Technical Support, ILC Dover, Chicago, USA

14:40 Novel Antibody Drug Conjugate Manufacturing - Synthesis, Conjugation, and Coordination.

• Synthesis and conjugation:
• Technology transfer
• Scale-up
• Qualification
• ADC Toxicology lot
• ADC GMP lot

Dr. Thomas Nittoli,
Director, R&D Chemistry Therapeutic Proteins, Regeneron Pharmaceuticals, Inc, New York, USA

BLOCK #3 CLEANING VALIDATION

15:15 Cleaning Validation as one driver to prevent cross-contamination.

• Introduction to health based exposure limits
• Regulatory requirements and audit experience
• Case study

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.

• Understanding Cleaning Validation as Process Validation
• Using HBEL for a cleaning risk assessment
• Setting a single residue limit for all the equipment
• How to focus cleaning validation activities on high risk situations

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.

• What is GMP - cleaning and Occupatiol Safety cleaning validation and how to apply it scientifically? (Richard Denk)
• What are the key HSE leadership qualities you need in HPAPI manufacturing? (Tim Briggs)
• What compounds should be considered highly toxic? (Ester Lovsin Barle)
• What analytical techniques and quality assurance approaches are key in HPAPI manufacturing?
• What is theory and what is practice in IH monitoring?
• What should you consider before investment into engineering solutions for your HPAPI manufacturing?

18:00 Chairman’s closing remarks and end of day one

19:00 Business dinner