Highly Potent APIs Summit 2019 - Kongress / Konferenz von Qepler s.r.o.

Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.



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.


Day 1st | Wednesday, 20 February 2019

08:30 -   Registration and Welcome Coffee 08:50 -   Opening Address from the Chairman


09:00 -  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, Germany

09:35 -  Speed ​​Networking


10:15 -  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, United Kingdom

10:50 - Morning coffee and networking break

11:10 - An Ipsen Case Study in Potent Compound Handling.

This session will describe the efforts undertaken by Ipsen to plan, design, implement and manage a highly potent compound employed in product manufacturing.

Mike Whaley, VP Global EHS, Ipsen, USA

11:55 - 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, Distinguished validation expert, Gedeon Richter, Hungary

12:30 - 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, United Kingdom

13:05 - Business lunch

14:05 - PSD 3 Spray Dryer with results less than 1 ug/m3 using flexible containment.

Christopher Gomez, Health Safety and Environmental Officer - US Operations, Hovione, 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, USA


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, 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, 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, USA

17:30 - Roundtable Discussions

18:00 - Chairman's closing remarks and end of day one 19:00 - Business dinner


Day 2nd | Thursday, 21 February 2019

08:00 -  Registration and Welcome Coffee08:40 -  Opening Address from the Chairman


08:50 - Workshop: How to identify high potency and high toxicity and what to do with it.

  • Data mining: Key information that determines toxicity and potency
  • Data interpretation: What should you ask yourself to interpret toxicity and potency correctly
  • Limit setting: How to set Health Based Exposure Limit
  • Using the limit: How to use the OEL and PDE in the risk assessments.

Ester Lovsin Barle, PhD, MScTox, ERT, Head Corporate Toxicology, Lonza AG, Switzerland

09:50 - Exposure Monitoring at the workplace - challenges due to workplaces and the new EN689.

  • Defining monitoring strategy for exposure monitoring
  • Exposure monitoring from planning to execution
  • Challenges during exposure Monitoring in the daily life
  • Changes in exposure Monitoring due to EN689

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

10:25 -  Morning coffee and networking break

10:55 - Understand, evaluate and mitigate Risks of occupational Exposures.

  • Explore classic occupational hygiene approach vs. innovative risk evaluation approach
  • Hazard based approach vs. risk based approach
  • PPE dependency vs. containment dependency
  • Over engineering vs. adequate containment

Toral Mehta, CIH, CSP, Head Industrial Hygiene and Containment, Health, Safety, Environment, Novartis, Austria

11:20 - Chemical Exposure Assessment and Control; the Bayer HPAPI approach.

  • Occupational Health & Safety Risk Assessment
  • Exposure Modelling & Monitoring
  • Controlling exposures to HPAPI’s
  • Validation of a banding approach

Kees Hommes, Global Occupational Hygiene and Safety Manager, Bayer AG, Germany


12:05 - To Be Announced.

Yossi Shapira, Assoc Director, MS&T S.M.E, Laboratories, Containment, Lyophilization technologies, Teva Pharmaceuticals, Israel

12:40 -  Business lunch

13:40 - Analysis of containment testing.

  • Growth in HPAPI processing and how containment requirements are being influenced
  • Analysis of SMEPAC assessments – the general requirements and the irregularities in how tests are performed
  • Interpretation of results and comparing like for like
  • Review of swab analysis
  • Laboratory testing vs real world

Michael Avraam, Global Product Manager for ChargePoint PharmaSafe, ChargePoint Technology Ltd, United Kingdom

14:15 - 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, USA


14:50 - Challenges and Successes in Externalization of the ADC Supply Chain.

  • Strategizing the best outsourcing practices for producing and testing ADCs for use in clinical trials
  • Establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer
  • Gaining insights into the complex technology transfer process for ADC manufacture and analytical control
  • Sizing appropriately of ADC support network to expedite transition from clinical to commercial manufacturing

Firelli Alonso, Ph.D., Senior Director, External Supply BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc., USA

15:25 -  Afternoon coffee and networking break

15:55 - Development & Manufacturing Considerations of High Potent Drug Products – a CDMO’s perspective.

  • Trends of High Potent API’s and a CDMO view on the future of supporting high potent drug product manufacturing
  • Regulatory considerations in handling special category of compounds in a segregated infrastructure.
  • Case studies and containment solutions in handling potent API’s in drug product manufacturing
  • CDMO view on strategizing supporting high potent API and DP manufacturing support to the pharmaceutical industry

Anil Kane, Ph.D., MBA, Executive Director, Global Head of Technical & Scientific Affairs Pharma Services, Patheon, Part of Thermo Fisher Scientific, Canada

16:20 - OUTSOURCING 4.0: innovative Pharma creates the CMO net.

  • New frontiers: sterile bio-respiratory and modified-release drugs
  • Research & developing of CMOs
  • Relationships & Quality without compromise
  • Assessing results at production scale

Enrico Bettetini, R&D Technology & Pilot Manager, Teva Pharmaceuticals, Italy

16:55 -  Roundtable Discussions 17:25 -  Chairman's closing remarks and end of summit



  • EMA and GMP guidelines: novel requirements and considerations
  • Staying compliant with occupational HSE regulations and policies
  • Best practice containment strategies for highly potent APIs
  • Utilizing quality risk management practices to HPAPIs production
  • Handling and optimizing early process development
  • Understanding and developing a robust scale-up process
  • Handling highly potent compounds for ADC generation
  • Design and cleaning considerations for manufacturing facilities
  • Selecting the right CDMO partner for HPAPIs project
  • Successful technology transfer and outsourcing strategies



  • Pharmaceutical
  • Biotechnology
  • Chemical
  • CDMOs
  • CMOs
  • CROs
  • API & HPAPI manufacturers & suppliers
  • Bioprocessing services and equipment
  • EHS consultancies
  • Engineering contractors
  • Equipment suppliers
  • Exposure and containment solution providers
  • Finance and investment institutions
  • Handling and containment services
  • Occupational and industrial health & safety advisors
  • PPE manufacturers
  • Raw materials suppliers
  • Safety services
  • Training providers


  • API, HPAPI & Impurities
  • Environmental, Health & Safety
  • Industrial Hygiene
  • Occupational Toxicology
  • Risk Assessment, Evaluation & Mitigation
  • Hazard Assessments
  • ADE, PDE, OELs, OEBs
  • Quality Control & Assurance
  • Aseptic Processing
  • ADC & New Molecules
  • CMC
  • Chemical Manufacturing, Processes & Synthesis
  • Compounds Manufacturing
  • Contamination
  • Containment
  • Drug Process Development
  • Extraction
  • Isolation
  • Formulation Development
  • Laboratory Services
  • Manufacturing
  • Materials Management
  • New Technologies
  • Plant & Site Management
  • Facility Design & Equipment Selection
  • Cleanrooms
  • Process Chemistry
  • Process Development & Engineering
  • Raw Materials
  • Regulatory
  • Research & Development
  • Toxicology
  • Validation
  • Corporate & Business Development
  • External Supply
  • Marketing
  • Outsourcing
  • Partnerships & Alliances
  • Sales Development
  • Strategic Development

SG-Seminar-Nr.: 5210031

Anbieter-Seminar-Nr.: qhpapi19

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