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What’s Changed in HPAPI?

9:45 am Chairs Opening Remarks

  • Bob Sussman Managing Director, SafeBridge Consultants

10:00 am Panel Discussion: Future Pipelines in the HPAPI Landscape & World Regulations


Looking beyond oncology, which modalities (CNS, hormones, oligonucleotides etc.) are on the rise in HPAPI Manufacturing

  • How does HPAPI regulation and quality control vary across the US & EU
  • How do we assess the safety profiles for these therapeutic agents and what effect do these pipelines have on EHS processes?
  • What can be applied to HPAPI manufacturing from changes in guidelines for sterile manufacturing and antibiotic manufacturing. Adapting existing systems to meet regulatory compliance for novel potent compounds
  • How will these evolving pipelines effect product stewardship in the future; will a rise in flexible/single use containment effect sustainability goals?

10:45 am HPAPI Isolator Design Methodology – The Full Life Cycle Safety Process


  • • Process for assessment, design, manufacturing, testing, installation, and disposal to achieve the process requirements
    • Game changer performance using fully disposable flexible film isolators
    • Portable and Configurable isolation systems from Formulation to Production
    • Speed to next batch by reducing / eliminated cleaning and validation

11:15 am Speed Networking


An innovative 1-2-1 networking experience. Get matched with fellow conference attendees for a 5-minute introductory chat, share a virtual business card at the touch of a button and expand you HPAPI expert network!

11:45 am Morning Refreshment Break


Head into the informal Networking Room to catch up with peers over a hot drink to reconnect. You can also find out more about the latest solutions in the Virtual Exhibition Hall with 1-2-1 meetings with our partners!

Promoting Best Practice in R&D

12:15 pm Freeze-drying of drugs containing highly potent APIs – Characterization of heat and mass transfer in protective bags


  • Introduction to lyophilization and the concept of blow-out as a contamination/ safety issue
  • Relevance and value of sublimation tests to understand your lyophilization process
  • Influence of protective bags on your freeze-drying process

12:45 pm Default OELs for Data-Poor Small Molecule Drug Candidates


  • Analysis of OELs of pharmaceutical drug substances
  • Discussion of disease area and mode of action as the basis for default OELs
  • Guidance for assigning default OELs for data-poor small molecule drug candidates

1:15 pm End of R&D Track

Six Sigma Process Development

12:15 pm Case Study: How to Handle HPAPIs in Chemical Development


  • GMP-compliance and regulatory environment
  • Prevention of cross contamination in shared facilities
  • Cleaning of equipment in manufacturing of highly potent APIs

12:45 pm Robust Control Strategy Development for Continuous Manufacturing of Low Dose Tablets


  • This talk will cover the development of a multi-faceted control strategy for low dose tablets
  • Focused on developing a design space across integrated continuous operations for continuous wet granulation and compression
  • Understanding the interactions across continuous operations and process system dynamics

1:15 pm Design of a Mid-Scale HPAPI Commercial Facility

  • Jason Korbel Technical Services Manager, Cambrex Charles City


  • 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

1:30 pm Networking Lunch


Grab a bite while visiting our Virtual Exhibition Room. Schedule 1-2-1 meetings with our event partners to find out how they can support your HPAPI manufacturing.

Cross the Bridge from R&D to Clinical Trials

2:15 pm From R&D to First-In-Human Clinical Trials


  • Where do you start? Building a CMC plan and identifying critical activities to start immediately
  • What is “phase-appropriate” to kickoff a phase 1 safety study?
  • Special considerations for highly potent drugs

Meeting Demand in Commercial Manufacturing

2:45 pm GS-9688 for Hepatitis B: Developing a Potent Compound at Gilead Sciences

  • Chris Regens Associate Director & Senior Scientist , Research, Gilead Sciences


  • Discussing the development of a high potent small molecule API at Gilead
  • Challenges with external manufacturing and micronization of a high-potent API
  • How these challenges guided the construction of an internal high-potent (cat. 3B) development and manufacturing facility

3:15 pm Afternoon Refreshment Break

Facility Design of the Future to Enhance Capabilities & Efficiency

3:30 pm Fast Speed Manufacturing Scale Expansion of a High Potent Product Process – from Lab Scale to Monoplant within 30 Months

  • Sean Diver Director, Commercial Development, Lonza
  • Christian Noti Team Leader, API Development Services & HPAPI Lab Manufacturing, Lonza


In an extensive case study, the critical success factors enabling successful process implementation, fast manufacturing scale expansion, ergonomic and robust design of a new efficient plant asset applying a mono plant approach are presented for a highly potent product:

    • A robust approach for a substantial tech transfer and compliant manufacturing of a very high potent compound
    • Parallelization of workstreams enabling parallel process development/characterization, clinical supply, and commercial mono plant asset realization based on a solid and flexible workforce
    • Key factors to ensure implementation of a “right first time design” plant
    • Importance of strong in house experience for quality and safety, process development, and plant construction capabilities ensuring compliant and efficient manufacturing of a very high potent product


4:00 pm Future of Flexible Manufacturing: Integrating & Adapting for High-Potency Clinical Manufacturing


  • Merck’s innovative strategy is to build a new, state-of-the-art facility with flexible, high-potency manufacturing to include both modular and podular design features
  • This talk will focus on the facilities of the future that will challenge the sterile and oral product development and manufacturing status quo
  • Ideas around using modular and podular self-containing units with isolator systems to be used for high potency development and for manufacturing will be shared

4:45 pm Poison plants, snakes and toad venom – How bad can it be?


  • Regulatory drivers for HBELs for natural health products
  • Unique challenges associated with natural health products
  • Example cases

5:00 pm Chairs Closing Remarks

  • Bob Sussman Managing Director, SafeBridge Consultants

5:05 pm End of Day One