December 3-5, 2019

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

Next course is December 3-5, 2019 at the Northeastern University Biopharmaceutical Analysis Training Laboratory

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