Sterile Manufacturing & HPAPI Environment

8:45 am Opening Remarks

  • Robert Sussman Managing Director, SafeBridge Regulatory & Life Sciences Group

Post Covid-19: Outsourcing & Partnership to Progress HPAPI Pipelines

9:00 am GMP Inspection Excellence for Highly Potent API Manufacturing


– Introduction to WHO Prequalification Programme (PQP) and inspections of pharmaceutical manufacturers for WHO PQP
– WHO Guidelines used for inspection of highly potent or hazardous substance
– Newly adopted points to consider documenting for manufacturers and inspectors on environmental aspects
– Frequent challenges for the industry; how do these challenges differ for inspection in Asia vs US?

9:30 am Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production


• Is the application of negative (HPAPI) or positive (Sterile) pressure cascades most appropriate?
• Design of engineering controls for sterile production and reduced cross contamination for quality assurance
• Revisions to Annex 1 and surrounding regulatory landscape
• Measuring product quality and operator safety in sterile HPAPI manufacturing

10:00 am Ventilation and Sustainable Laboratories – An Industrial Hygiene Perspective


• Historically high general ventilation requirements in laboratories offer an opportunity for reducing environmental impact
• Systems like ASHRAE Laboratory Ventilation Design Levels and Demand Based Control applications aid in this goal
• Case Study: A look at practical implementation, benefits, challenges

10:30 am EHS Integration in Capital Projects & Tech Transfer

11:00 am
Structured Networking & Morning Coffee Break

Quality Control & Risk Management

12:00 Round Table Discussions:
Hear from subject matter experts on the sessions below, whilst sharing your own experience and challenges with colleagues to devise actionable next steps to implement in your organization.

Evaluating Risk Curves in Pharma for Product Quality & Patient Benefit

• Formulation, impurities, extractables & leachables, what are the key risks to consider for
HPAPI product quality assessments?
• How has ultra-rapid pharmaceutical development changed the industry’s view of pharmaceutical risk curve applications
• Taking risk management inspiration from the department of defence; how can pharma and DOD collaborate to evaluate immediate and long-term threats to public health

Douglas Kiehl, Senior Director, Eli Lilly & Company

Impact of Supply Chain Challenges on Single Use vs Multi-Use Equipment

• How supply chain challenges, cost vs risk assessments and sustainability goals are impacting pharma industry’s approach to choosing between single use or multi-use equipment for potent production.
• Establishing cleaning validation projects for processes that previously leveraged single use equipment, to ensure product quality is retained in now multi-use environments
• Contrasting cleaning validation approach and challenges for large vs small molecules

Rajyalakshmi Vathyam, Cleaning & Sterilization Sr. Validation Engineer, Takeda

12:30 pm Cleaning Validation Risk Assessments & Setting Appropriate Cleaning Limits for HPAPI Manufacturing


• Review of regulatory guidelines and requirement on risk assessment in cleaning validation
• Discuss risk assessment uses in cleaning validation
• Risk assessment points to consideration and case study on routine monitoring risk assessment
• Setting appropriate residue limits for equipment
• Applying practical approaches and case study on potent API manufacturing

1:00 pm 360 Degree Analysis of High Containment Environments Risk Management


• Balancing EHS risk, product quality risk and supply chain risks to traverse unpredictable events for supply continuity
• Dual Sourcing, staffing, and approaches to mitigate risk
• The power of an integrated cross-functional approach between Quality, Engineering, Regulatory, EHS and Risk Management professionals

1:30 pm
Networking Lunch & Exhibition

Process Safety in Radiopharma & Gene Therapy

2:30 pm Radiopharmaceuticals – Containment and Development Considerations


• Special handling and containment for radiopharmaceuticals development – how does this overlap with high potency handling?
• Manufacture at CMO/ In house vs onsite at hospital
• Development & manufacturing timelines and logistics

3:00 pm Weaving EHS Culture into the Fabric of Gene Therapy R&D Environment


Weaving EHS Culture into the Fabric of Gene Therapy R&D Environment
• What are the risks when working in gene therapy Research & Development – standard and non-standard risks, physical and psychosocial?
• Integrating an EHS program in R&D teams and upskilling scientists to be biosafety practitioners
• Risk assessing material of unknown potency in early development and encouraging best practice at all times
• Transition into GMP mindset

15:30 SOP Working Groups Audience Discussion: These working groups are an opportunity to share your best practices with the audience as well as to learn from others on their way of working

Fire Safety in HPAPI Production
• Fire extinguisher systems for toxic materials
• Combustible dust management

Spills & Leaks
• With often liquid-based Biologic drugs, spill and leak hazards become more provident
• Cleaning SOPs for spills to ensure so product remains post liquid evaporation
• Stress testing containment for leak prevention

4:00 pm Chairs Closing Remarks

  • Robert Sussman Managing Director, SafeBridge Regulatory & Life Sciences Group

4:30 pm Close of 11th HPAPI Summit