Attendee login, Exhibition Open, Networking and Meet up

Chair’s Welcome Note

Pauline L McGregor, Ph.D CChem MRSC, PMcG Consulting, Canada

GMP Guidance on Stability: C.02.027, C.02.028

Presented by: Paul Gustafson, Health Canada

Predictability of Forced Degradation Studies for Real World Stability

The objective of this presentation is to provide a solid foundation for designing and conducting effective forced degradation studies and an understanding of the strengths and limitations of forced degradation for predicting long-term stability results.

• Historical background and regulatory framework
• Specific recommendations for conditions of stressing
• How “meaningful” are the data from these conditions?
• Data “mined” from 15 compounds
• Comparison of “Real World” degradation to stress testing results
• QbD Applied to Stability
• Examples of “Holes” in Degradation Knowledge Space
• Interesting Case Study examples

Presented by Dr. Steven Baertschi, President, Baertschi Consulting LLC

Virutal Break | Exhibition viewing and Meet Up

Stability studies for Oligonucleotide and Peptide products

Oligonucleotides and peptides are “intermediate” in size between well characterized proteins and small molecule pharmaceuticals and therefore present unique concerns in design of control strategies. The regulatory guidances in this area are not clearly defined. This talk will address regulatory and scientific considerations for the design of stability studies for these two classes of therapeutics.

Present by: Dr. Nanda Subbarao, Group Leader & Senior Consultant, Biologics Consulting

Conducting Excipient Compatibility Studies (ECS)

• Review the importance of excipients and problems they can cause
• Summary of different types of ECS approaches
• Details of ECS approach preferred at Patheon
• Case study to demonstrate how application of good science in interpretation of ECS data can help with best selection of product formulations

Presented by: Dr. Geoff Carr, Director, Analytical Development, Thermo Fisher/Patheon Inc

Panel Q & A, Discussion

Paul Gustafson, Health Canada
Dr. Steven Baertschi, Baertschi Consulting LLC
Dr. Nanda Subbarao, Biologics Consulting
Dr. Geoff Carr, Thermo Fisher/Patheon Inc.

Virtual Working Lunch- Breakout Sessions

Interactive Discussions on CSV project insights and success factors (Part 1)

With real examples of Chromatographic Data System

Lead by: Kia Kahhali, Founder and CEO, APS Compliance Consultants Inc.

Stability Update: Practical Approaches to Performing In-Use Stability Studies

The discussion will center on practical approaches to consider when performing in-use stability studies based on regulatory guidelines and best industry practices. Some of the challenges and points to consider when performing such studies will be detailed and shared with the participants.

Lead by: Mathieu Fournier, M.Sc., Director, R&D and Scientific Affairs, Neopharm Labs

A Roadmap to Establishing, Managing, and improving a Stability Program

Part 1 – Establishing

• Determine scope of stability program-all products, only certain product lines, etc.
• Determine critical attributes of product that may change over time (what you will test)
• Assess existing resources (Technicians, Chemists, Engineers, lab equipment, capacity)
• Determine best option for managing stability data (Lab notebook, Excel spreadsheet, LIMS)
• Purchase and qualify chambers, IQ, OQ, PQ, including temperature and humidity mapping
• Write SOPs for Stability Program, including everything from temp. and humidity excursions in chambers, to handling Out-of-Specification stability test results, and business continuity
• Design templates for stability protocols, reports, termination requests, sample disposition, etc.

Presented by: Christopher (Chris) V. Latoz, B.S. , Stability Manager, Hollister Incorporated in Libertyville, IL

Predicting Shelf Life with the Accelerated Stability Assessment Program (ASAP) and ASAPprime®

• The scientific basis behind risk-based predictive stability studies (ASAP)
• Designing and running ASAP studies (4-6 weeks) to predict long-term stability using ASAPprime®
• Modeling shelf life with different packaging options and storage conditions
• Using ASAP to inform product development
• Case studies comparing real-time degradant growth and color change to model predictions

Presented by: Dr. Kristina Flavier, Sr. Scientist, FreeThink Technologies, Inc.

Virutal Break | Exhibition viewing and Meet Up

Shining Some Light into the ICH Q1B Guideline on Photostability

The objective of this presentation is to cover the multiple aspects related to assessing stability of photolabile compounds in pharmaceuticals (small molecules) and biopharmaceuticals (biologics). The topics will include:

• Basics of photochemistry;
• Light sources and levels of exposure;
• Sample presentation and analysis;
• ICH Q1B guideline: main concepts and recommendations;
• Specific aspects related to dosage forms (i.e. oral solids, injectables, etc.);
• Assessing risks in manufacturing and packaging configuration;

Particularly, this presentation will focus on formulation aids in preventing photodegradation. Ultimately, this forum will serve as an opportunity to discuss currently identified gaps in the ICH Q1B.

Presented by: Dr. Steven Baertschi, President, Baertschi Consulting LLC

Bulk holding studies

Presented by: Emily S. D. Trubee, Stability Manager, R&D, Adare Pharmaceuticals, Inc.

Panel Q & A and Discussion

Christopher (Chris) V. Latoz, B.S. , Hollister Incorporated in Libertyville, IL

Dr. Kristina Flavier, FreeThink Technologies, Inc.

Dr. Steven Baertschi, Baertschi Consulting LLC

Emily S. D. Trubee, Adare Pharmaceuticals, Inc.

Chair Closing Remarks: Pauline L McGregor, Ph.D CChem MRSC, PMcG Consulting, Canada

Conclusion of Day 1 Conference