Attendee login, Meet ups and Networking

Chair’s Welcome Note

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

Stability studies, analytical methods and their connection with specifications

Stability studies are fundamental requirements to demonstrate Drug Substance (DS) & Drug Product (DP) are fit for purpose, efficacious and safe, over a period of time.

The combination of appropriate conditions, tests and criteria and essential components of a stability protocol at every stage of development / manufacturing.

For both small molecules and biologics we will discuss:

• The interplay of the study, analytical methods, their choice and setting criteria.
• The data and the impact / alignment with DS & DP release (or shelf life) specifications
• The changing needs at different stages of development.

Illustrative examples include:

• Stability study designs
• Specification setting justification with stability data

Present by: Dr. Peter Tattersall, Senior Principal Scientist, Bristol-Myers Squibb Company

Selection and validation of Stability Indicating methods for Biologics

An effective stability program relies on robust stability indicating methods which are capable of generating reliable quantitative or limits test results for the degradants generated during storage of the product. The method characteristics such as sensitivity, limit of detection, accuracy and precision must be fit for the purpose of evaluating trends in the degradant levels which impact the safety, quality and efficacy of the product when administered to the patient within the expiry period of the product. The purpose of validating the methods is to ensure that the right analytical procedures match the product specification and both are appropriate for degradation pathway. This talk addresses how to choose and validate methods for well characterized proteins and other biologics products.

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

Mid-morning Refreshment Break & Exhibition viewing

Challenges of Stability Studies with Combination Products

• Rationales for combination (combo) products
• mportance of API-API compatibility testing
• How to decide whether combined or separate analytical procedures should be applied
• Some issues with related substances testing
• How to deal with new unknown impurities
• When we don’t know which API was the source
• How to try to establish the source
• Issues with dissolution testing

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

Stability LIMS- Selection, Implementation, and Validation

• Understand the many benefits of using a LIMS for stability studies
• Formation of Project Team-Executive Sponsor
• Gather and rank User System Requirements
• Select, write justification, and purchase LIMS
• Configure Test, Validation, and Production Environments
• Execute test scripts, documentation, approval signatures-21 CFR Part 11 in Validation Environment
• Train additional users in Test Environment
• Develop User Guide and other documentation
• Go Live-(Production Environment)
• Data migration of legacy studies

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

Co-Presenter: Ilona Endisch, B.S. in Computer Science, Associate Director, Product Innovations - North America, Novatek International

Panel Q & A, Discussion

Dr. Peter Tattersall, Bristol-Myers Squibb Company
Dr. Nanda Subbarao, Biologics Consulting
Dr. Geoff Carr, Thermo Fisher/Patheon Inc.
Christopher (Chris) V. Latoz, B.S. , Hollister Incorporated in Libertyville, IL

Virtual Working Lunch- Breakout Sessions

Interactive Discussions on CSV project insights and success factors (Part 2)

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

In Covid 19 Times, Remote Implementation & Training of Quality Softwares

Lead by: Corinne Cleary, BCompSc, Product Specialist: Technical Processes and Innovation, Novatek International

Stability indicating HPLC methods - development and validation

Small molecule stability indicating HPLC method is the cornerstone of a registrational stability study and release testing of Drug Substance (DS) & Drug Product (DP).

Method development requires a number of areas of study including stability indicating selectivity based on potential degradation profiles obtained from previous knowledge and a detailed forced degradation study.

Validation should be performed according to ICH Q2 and formally documented with both a protocol and a report.

The outline of the presentation is:

• Industry guidance and recent trends
• Internal practices
• Method development / validation workflow
• Forced Degradation Studies
• ATP / QBD
• Validation / procedure documentation

Illustrative examples include:

• QBD development through to registrational stability
• TT approaches/experiences

Present by: Dr. Peter Tattersall, enior Principal Scientist, Bristol-Myers Squibb Company

Implementing GMP practices in the R&D phase to make the transition to commercialization easier and more seamless

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

Mid-Afternoon Refreshment Break

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

Part 2 – Managing

• The importance of proper stability sample handling, management, and inventory control
• Determine method (Strip Chart, Automated Monitoring System, etc.) and person responsible for monitoring chambers
• Sample presentation and analysis;
• Develop a schedule for routine cleaning, maintenance, and calibration of chambers

Part 3 – Improving

• Implement plan for disaster recovery-power failure, chamber failure, monitoring system failure
• Frequent Review of FDA Database of 483s
• Update Stability SOPs
• Reduction of Testing Time Intervals
• Apply 5S Principles to Work Areas
• Visual Management-Scrum Board

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

Transportation Stability Studies

Present by:
Farzana Saadat, Health Canada

Panel Q & A / Interactive Group Discussions

Dr. Peter Tattersall, Bristol-Myers Squibb Company

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

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

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

Conclusion of Conference