7:30 am Registration, Coffee & Networking

8:20 am Chair’s Opening Remarks

Investigating Strategies to Handle Innovative Potent Compounds

8:30 am Introduction of a High Potency Bi-Specific Antibody to a Multi-Product, Shared Clinical and Commercial Biotech Facility – A Case Study

Synopsis

  • A unique challenge for an established facility requiring:
    • Enhanced personnel protection and handling controls
    • Additional cross-contamination controls to address the risk to other products
    • The rapid development of sensitive product-specific analytics
    • A novel regulatory filing strategy and pre-introduction guidance from Health Agencies
    • Close collaboration between diverse departments:  QC, Analytical Development, Engineering, Occupational Toxicology, Manufacturing, Quality, Validation and Regulatory
  • Successes, lessons-learned, and improvements for future Hi-Potent product introductions

9:00 am HPAPI Best Practices: Requirements for Fully-Integrated Service-Offerings in a HPAPI & Cytotoxic Environment

  • Maurits Janssen Senior Director, Head of Commercial Development, API Development & Manufacturing, Lonza

Synopsis

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:

  • CASE STUDY: the 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

 

9:30 am Speed Networking & Morning Refreshments

Successfully Containing and Developing HPAPIs at Every Scale

10:45 am Maintaining Effective Containment Through Scale Up in a Generics Environment

  • Rich Arnett Manager, Industrial Hygiene, Pharmascience

Synopsis

  • Understanding how containment needs change as processes scale, backed up by IH data
  • Identifying and overcoming equipment challenges
  • Successfully utilizing disposable equipment to maintain safety and cost-effectiveness

 

11:15 am Successfully Containing and Developing HPAPIs at Lab Through to Pilot Plant Scale & Beyond

  • Jack Brown Senior Research Fellow, Boehringer Ingelheim

Synopsis

  • Establishing robust and scalable procedures early in development
  • Overcoming unexpected containment challenges encountered in the scale-up of potent compounds
  • Case studies investigating the establishment of procedures for handling HPAPIs in early stage development work

11:45 am Operation of a Fully Integrated & Versatile HPAPI Manufacturing Facility

Synopsis

  • Effective containment design strategy for handling HPAPIs form g to kg
  • IH monitoring philosophy
  • Purification strategy for HPAPIs SK Biotek

12:15 pm Networking Lunch

1:45 pm Process Safety Assessment in an High Potency Environment

  • Marco Jonas Associate Research Fellow, Process Development, AMRI

Synopsis

  • Process safety testing vs. HP requirements – overcoming challenges
  • Dust explosion assessment for potent compounds
  • Calorimetry for potent compounds

2:15 pm Lessons Learnt from the Establishment of New Engineering Standards for Potent Compounds

  • James Ratway Associate Director, Pharmaceutical Development, AbbVie

Synopsis

  • Understanding the key decision points navigated in the establishment of new engineering standards
  • Establishing risk-based primary and secondary containment standards applicable from lab all the way through to full-scale manufacturing
  • Case study: Exploring the design of new potent compound facilities

2:45 pm Design of a Mid-Scale HPAPI Commercial Facility

Synopsis

  • Using risk based assessment to develop occupational exposure limits
  • Challenges of design and operation of a multi-purpose HPAPI facility
  • Containment strategies utilized for maintaining flexibility

3:00 pm Afternoon Refreshments & Networking

Utilizing Data-Driven Risk Management Approaches

3:30 pm Applying a Risk Based Approach for Defining Exposure Controls in the Workplace

Synopsis

  • The OEL and band are not the only criteria for selecting exposure controls
  • The value proposition for applying risk based data driven decision-making for exposure controls
  • The dose makes the poison

4:00 pm Deep Dive: Enabling Containment Technologies

Synopsis

  • Background
    • Drug Linker Syntheses and pipeline focus in late 2016
    • Fear and misunderstanding of toxicity/handling requirements/engineering controls
    • HPAPI Facility Design Phase identifies high aerosol risk unit operations of typical processes to be conducted in isolators
    • Pipeline needs still need to be supported until completion of facility – IH Studies conducted for lowest exposure targets to determine if flexible containment technologies can meet process containment needs
    • IH monitoring program philosophy (when surrogate monitoring is executed, value back to the business)
  • Unit operations investigated in IH Studies
    • Description of equipment and operational challenges
    • Description of how IH experiments designed to represent actual processes (technician, IH, Tech Ops collaboration)
    • Description of unit operation studied
  • IH Results of Individual Unit Operations
    • Description of monitoring methodologies
    • Sample locations/intervals
    • Data analysis and interpretation (trends from operational causes)
    • Conclusions and recommendations moving forward

 

5:00 pm Chair’s Closing Remarks

5:15 pm End of Conference Day 1