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What’s Changed in HPAPI?
9:45 am Chairs Opening Remarks
10:00 am Panel Discussion: Future Pipelines in the HPAPI Landscape & World Regulations
Synopsis
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
Synopsis
- • 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
Synopsis
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
Synopsis
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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
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
1:30 pm Networking Lunch
Synopsis
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
Synopsis
- 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
Synopsis
- 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
Synopsis
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:
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- 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
Synopsis
- 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?
Synopsis
- Regulatory drivers for HBELs for natural health products
- Unique challenges associated with natural health products
- Example cases