3rd Annual Highly Potent APIs Summit 2023

Tentative Schedule:

Central European Time (CET, Prague, UTC/GMT +1 hour)

11:40 Opening Address

11:50 Sources of cross-contamination risk in solid dosage form manufacturing

• Guidelines regarding cross contamination and toxicological approach
• Complexity in risk analysis of cross contamination
• Case study - a tabletting plant

Dr. Ildiko Ziegler,
Quality Assurance Manager, Vanessa Research, Hungary

12:30 Cleaning validation – Enhanced approach required for Highly Potent APIs?

• Health Authority Requirements
• Case Studies
• Cleaning Process Design Phase

Andreas Schreiner,
Director of Validation, Manufacturing Science and Technology, Novartis, Basel, Switzerland

13:10 Coffee break

13:30 EHS Integration in Capital Projects and Tech Transfer

• Risk Reduction and EHS Management Elements
• Proactive approach for EHS review and input during TT and Capital planning process
• How to Address EHS issues early during the design phase.
• EHS deliverables during the planning, design and installation of processes, equipment and facilities to support TT
• Verification: FAT/SAT/PSSR

Dr. Ing. Olindo Lazzaro, PE, MSc, CSP, EMBA,
Head, Global EHS by Design, CSL Behring, Switzerland

14:10 Integrating EHS into the RFP Process for HPAPIs

• Integrate EHS as early in the process as possible
• Having the right team F2F with customers/clients
• Information needs to ensure a smooth scoping process
• Resolving OEB and/or OEL disagreements with customers/clients quickly
• Determine who pays for containment, risk assessments, and waste costs

Jay L. Brown,
Associate Director of EHS, Piramal Pharma Solutions, USA

14:50 Quantitative Measurement of Risk in Cleaning using ASTM Standards

• Why do we Need to Measure Risk in Cleaning?
• What are the ASTM Cleaning Standards?
• What are the Components of Risk in Cleaning?
• What are the Toxicity, Process Capability and Detectability Scales?
• What is the Shirokizawa Matrix?

Andrew Walsh,
President, Center for Pharmaceutical Cleaning Innovation (CPCI™), USA

15:50 Coffee break

16:10 Occupational Hygiene Programs and Practice Standards of Care

• The Future Benchmark for Occupational/Industrial Hygiene Programs
• What Might a Pharma Mercedes Benz Look Like?
• Free OH Program Development & Management Tools
• Who Are Your Critical Team Players?

Nancy M. McClellan, M.P.H., CIH, CHMM,
Principal Industrial Hygiene Expert & CEO, Occupational Health Management, PLLC, USA

16:50 The Ongoing Significant Toxicological Challenges in Developing Efficacious Antibody Drug Conjugates (ADCs)

• History of ADCs
• Monoclonal Antibody (or Antibodies Selection)
• Linker Technology
• Payload/Warhead/Small Molecule Selection
• Approved/Marketed ADCs and Efficacy
• Containment Requirements

Dr. Greg Erexson, PhD, DABT, FATS, FRSB, ERT
AbbVie Retiree, Greg Erexson Toxicology Consulting, LLC, USA

17:30 Exposure Assessment Challenges for New Modality Potent Compounds in R&D

As the shift in the pharmaceutical R&D environment goes from small molecule, solid, powder handling transitions to large molecule, liquid handling, how does Industrial Hygiene and the greater EHS team adapt to new methods of risk assessment and control? This presentations addresses:

• The partnership of Industrial Hygiene and Biosafety practices to mitigate employee exposure to pharmaceutical ingredients that have both biological and chemical components or require additional employee protection.
• Understanding that traditional Industrial Hygiene risk assessments can be difficult when there is limited knowledge or data on the API being handed. How do we make our best educated recommendation on controls that’s not overly conservative?
• Designing spaces for adaptability and flexibility.
• Case studies highlighting the challenges of controlling for new modality potent compounds in an R&D setting.

Andrea Guytingco, MPH, CIH,
Sr. EHS Business Partner, Takeda Pharmaceutical Company Limited, USA

18:10 Closing remarks and end of day two

Tentative Schedule:

Central European Time (CET, Prague, UTC/GMT +1 hour)

11:20 Opening Address

11:30 Flexible Isolator - Occupational Hygiene Experience.

• technical details and design of a flexible isolator by lugaja
• results of exposure monitoring at the flexible isolator
• Results of exposure monitoring of the operator
• scope and challenges between monitoring of operator exposure according to EN689 and monitoring of containment performance according to SMEPAC

Silke Buechl,
Deputy Managing Director, Occupational hygienist, Praevena AG, Basel, Switzerland

Thomas Weingartner,
Managing Director, Lugaia Deutschland GmbH, Germany

12:30 Occupational Exposure Bands

• What are OEBs?
• History of OEBs
• Use and communication of OEBs
• Case studies - OEBs for compounds with limited data

Dr. Martin Kohan PhD, ERT, DABT,
Managing Toxicologist, SafeBridge Europe, Ltd., United Kingdom

13:10 Health-based exposure limits (HBELs) for biotechnological products – when needed and how are they set?

• HBELs (OELs and PDEs): Why are they needed?
• Principles for the calculation of OELs and PDEs
• Are OELs and PDEs required for biotechnological products/new modalities?
• Particularities e.g., for protein- and RNA/DNA-based therapeutics
• Considerations for implementation

Dr. Claudia Sehner,
Senior Toxicologist, Boehringer Ingelheim, Germany

13:50 Coffee break

14:10 How to derive health-based exposure limits (HBEL) for ADCs

• Example of an Antibody-Drug-Conjugate (ADCs) at Takeda
• What are health-based Exposure Limits (HBEL)?
• Default HBEL for ADCs
• HBEL calculation methods for ADCs

Lisa Wiesner,
Occupational Toxicologist, Lonza, Basel, Switzerland

14:50 HBEL - containment and occupational hygiene monitoring

• Assessing the risk of exposure
• Defining the needed containment
• Occupational Hygiene Monitoring

Dr. Friederike Hermann,
Head of Occupational Hygiene, Lonza, CH

15:30 Antibody-Drug Conjugates – antibodies meeting HPAPIs for specific and efficient biopharmaceutical drugs

• The development and manufacture of ADCs - challenges and solutions
• The make-or-buy question – what to outsource and what to do in-house?
• Bayer’s ADC production concept
• Best practices for CDMO selection and outsourcing
• Understanding the success factors, risks and mitigations

Dr. Ulrich Rümenapp,
Head of Launch Preparation and Coordination, Bayer AG, Berlin, Germany

16:10 Coffee break

16:30 Ensuring product & worker safety in multi-product GMP facilities

• Identifying the ‘must haves’ vs the ‘nice to haves’
• Ensuring safety and acceptable risk without ‘over-engineering’
• Leveraging HBELs to achieve the required standard
• Choosing between flexible/disposable and rigid containment solutions

Richard Arnett,
Manager, Industrial Hygiene & Toxicology, Pharmascience Inc., CA

17:10 Continuous Processing as a Tool for HPAPI Development and Manufacturing

Christopher Lippelt,
Manager, Pharmaceutical Project Management, Eli Lilly & Company, Indiana, United States

17:50 Design Considerations for the Buildout of a New Small Molecule HPAPI R&D Laboratory

CONTINUUS Pharmaceuticals recently completed the opening of a new OEB4 Highly Potent API R&D laboratory earlier this year within 6 months from building occupancy.

This talk will touch on the comprehensive safety programs developed and the cross functional approach used to manage the buildout, focusing on the implementation of the hierarchy of controls.

Risk-based safety procedures, engineering controls equipment, and industrial hygiene practices used in the safe operation of this R&D laboratory will all be discussed.

Sean Keenan,
Pilot Plant Manager, CONTINUUS Pharmaceuticals, Inc., Massachusetts, United States

18:30 Closing remarks and end of summit