CURRICULUM

NEXT COURSES HELD

TO BE CONFIRMED

Northeastern University Biopharmaceutical Analysis Training Laboratory

PART ONE: Introduction to Biologics (Online)

What are Biological Medicines – Definition

Brief History of Biological Medicines

Biologic Medicines vs. Chemical Drugs

Difference Between Biosimilars and Generics

Characteristics – Structure
Clinical Studies Methodology

Analytical Characterization – Tools, Strengths, and Gaps

PART TWO: Comparability Throughout the Life-Cycle

SESSION 1: Welcome and Introduction

• Critical Concepts from Part One – Introduction to Biologics

SESSION 2: Control of the Product

Why comparability is needed-changes including post-approval variation for biologics

• Hands-on Training: HPLC Analysis of an Ab (and aggregates)
• Characterization (Mass Spec, Structural, Other): HDX, NMR, AUC, IMS, DLF, etc.; Method Validation; Stability; Control of the Process; Data Analysis: Best Practices and Common Errors
• High Pressure Liquid Chromatography (HPLC) and Aggregation
• Data Analysis: Best Practices and Common Errors

In hands-on training, attendees will be introduced to HPLC and perform an aggregation analysis of a mAb using the stand-alone UPLC system (with PDA).

SESSION 3: Risk Based Understanding of Categorization of Changes

How to do Comparability: ICH Q5E, Interpretation of the Data, Risk-Based Understanding of Changes

Acceptance Criteria; Statistical Considerations – Quality Aspects

SESSION 4: Risk Based Understanding of Categorization of Changes

• Hands-on Training: Categorization of Changes
• Intact Mass Analysis by direct infusion and LC-MS

In this hands-on training, the attendees will perform an intact mass analysis of a mAb, comparing direct infusion to the LC-MS data. The instrumentation used (TUV-UPLC-MS): Waters H-Class quaternary solvent manager, sample manager, column manager (two column version), UV detector (TUV), and Xevo-G2S.

Group Discussion on Intact Mass Analysis

Quality Elements of Biosimilar Development – Importance of Structure/Function Relationship

Biosimilar Development & Life-cycle management

PART THREE: Clinical Considerations for the Assessment for Biosimilars

SESSION 6: General Regulation in Biosimilar Development

Comparison of Biosimilar Guidelines

Biosimilar Regulations – APEC Economies

SESSION 7: General Regulation in Biosimilar Development

Understanding the difference between Comparability and Similarity

• CMC, Quality and General Clinical Considerations
• Structure Function Analysis and Clinical Pharmacology

Considerations of Immunogenicity in Determining Biosimilars

Getting into clinical trials

• Clinical trial methodology with specific emphasis on biosimilars
• Why are clinical trials necessary in the evaluation of the benefit-risk balance of biosimilars?

SESSION 8: Case Studies and Discussion

Biosimilar case 1 (e.g. Insulin)

Biosimilar case 2 (e.g. Insulin-analog)

Group Projects (2-3 subgroups)

• (e.g. filgrastim, infliximab, etanercept)
• Design a First-in-human Study for the Development of a Biosimilar Product

Design a Supportive Safety and Efficacy Study

PK, PD, General Considerations in Efficacy, Safety, and Immunogenicity 

SESSION 9: Extrapolation of Indication

Extrapolation of Indication (Both regulatory and industry perspectives)

• Principles of indication extrapolation
• Evidences required (analytical, nonclinical, clinical, etc.)

SESSION 10: Post Approval Monitoring

Post approval monitoring

• EMA requirements
• FDA requirements

SESSION 11: Wrap Up

Group Project (2-3 subgroups) Discussion

Wrap Up and Conclusion

Want to learn more about Experiential Education at the Biopharmaceutical Analysis Training Laboratory?