Course Description:

In the development and commercialization of biopharmaceutical products, historically most of the R&D and GMP attention has been focused on the manufacturing process and production facility. However, there has always been a vital role for the ‘other half’ of the equation: analytical testing and laboratory operations.

The global emergence of biosimilar products – where significant attention is given to analytical characterization and comparability – has turned a brighter spotlight on the analytics. It is expected that rationale for the design and execution of analytical studies, the selection of and validation of appropriate method technologies, the assessment of drug substance and drug product stability, and the establishment of meaningful, supportable specifications will be justified in regulatory dossiers.

This two day interactive course on CMC requirements for biopharmaceutical products will focus on the types of analytical CMC studies that are critical to the successful review and approval of product IND/IMPD and BLA/MAA filings. It will also discuss the vital role of laboratory quality systems in assuring the reliability and integrity of the data generated to demonstrate product comparability, quality and stability.

Complementary USB Drive for first 20 Registrations: Register Now and get a complementary USB drive containing over 200 global guidance documents and industry white papers applicable to the information discussed. Additionally attendees will be given links to many places where they can continuously update their knowledge of the topics covered.

Learning Objectives:

Upon completing this course on analytical CMC regulations, participants will:

  • Recognize the system of worldwide regulatory guidance applicable to biotech and biosimilar product CMC requirements
  • Understand why requirements for biotech products are so different from those of chemical products
  • Find exactly ‘where it is written’ for current and emerging CMC expectations for biotech/biosimilar products, and get copies of those regulatory documents
  • See how to implement a staged approach to establishing specifications for release and stability testing
  • Learn the current analytical technologies used for establishing biotech/biosimilar product characteristics and assessing comparability
  • Select the appropriate methods for release and stability testing
  • Design suitable qualification and validation exercises for method intended uses
  • Establish stage-appropriate ICH stability protocols
  • Learn the tiered approach for managing product reference standards
  • Recognize how much R&D data are exposed to regulatory scrutiny
  • See the new regulatory guidance on quality agreements with contract testing labs

Who will Benefit:

This course is designed for people tasked with designing, conducting, auditing, or managing key CMC studies; writing dossiers or responding to communications for submission to regulatory authorities; preparing for or conducting inspections of analytical labs for biotech or biosimilar products. Following personnel will benefit from the course:

  • CMC study directors
  • Method development specialists
  • Process development specialists
  • R&D scientists
  • QC technicians
  • QC laboratory managers
  • Stability program managers
  • QA professionals
  • CRO personnel
  • Technical writers
  • Laboratory inspectors
  • Regulatory professionals
  • Compliance professionals

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Current and Emerging Biotechnology/Biosimilars CMC Regulatory Requirements
    1. What sets of world-wide regulations detail CMC analytical study requirements for biotechnology/biosimilar products?
    2. What are the 10 (or 11 if biosimilar) non-negotiable CMC characterization, comparability, release specification and stability data packages required for a biotechnology-based product?
    3. Where is it written that these are the required CMC studies and data to be presented in each regulatory dossier for biotechnology/biosimilar products?
    4. What are some of the current CMC ‘hot buttons’ for biotechnology analytical and stability studies that are of increasing regulatory concern for chronic deficiencies in product dossiers?
    5. What are the current analytical questions for global development of biosimilar products?
    6. How the required CMC analytical and stability studies should be staged during the product development lifecycle?
    7. Which of these elements have the most critical project planning considerations based on their time and material requirements for biotechnology/biosimilar products, and why?
  2. Managing Stage-Specific Specifications for Biotech/Biosimilar Products
    1. Why do biotechnology products have different specification requirements versus traditional chemical products for comparability, product quality and consistency, and shelf life determination?
    2. What four main elements are critical for establishing reliable, meaningful product specifications for biotech and biosimilar products?
    3. What are the specification considerations for product-related heterogeneity in biotechnology products?
    4. What is the basis for specifications on product and process related impurities?
    5. How much detail is required on impurities and degradants at each phase of product development?
    6. What are the key points to include in the Justification of Specifications for drug substance and drug product?
  3. Analytical Test Method Selection and Specifications for Biotechnology/Biosimilar Products
    1. How do regulators and inspectors categorize analytical test methods?
    2. What are the commonly used and currently expected analytical methods for various types of biotechnology products (eg Mabs, vaccines, GT vectors, ADCs, etc…)?
    3. Why do biotech products require orthogonal methods for physiochemical characteristics as well as functional potency assays?
    4. What is the difference between methods used for characterization and comparability studies vs release and stability testing?

  1. Biotech/Biosimilar Analytical Methods: Development, Qualification, Validation, Tech Transfer and Bridging
    1. Which analytical test methods have to be validated, and by when?
    2. What is the difference between method validation and method ‘qualification’?
    3. How can you tell if method qualification or validation studies have been designed correctly for each analytical technology and intended use?
    4. What should you do to tech-transfer analytical methods from one lab to another?
    5. What should you do to make changes in release and stability analytical methods over time?
    6. What are the current expectations for generating and maintaining method lifecycle document packages?
    7. How can one separate tracking of method performance from product performance to monitor each method’s state of control?
  2. Design and Execution of Analytical Comparability Studies for Biotechnology and Biosimilar Products
    1. What are critical technical aspects of assessing biotechnology product comparability?
    2. How do comparability studies performed for developmental continuity differ from demonstration of analytical biosimilarity?
    3. What are key elements of conducting a biotechnology product comparability or analytical biosimilarity study?
    4. How do you strategically select among the collection of analytical methods for comparability/biosimilarity vs release/stability testing?
  3. Reference Standards and Materials for Biotechnology/Biosimilar Products
    1. What are some of the types and uses of biotechnology reference standards and materials?
    2. How do they differ from small molecule reference standards?
    3. What is the ‘tiered approach’ to establishing a master reference standard and qualifying working reference standards?
    4. How is biotechnology product reference standard stability monitored?
    5. How do you bridge new lots of reference standards and materials?
  4. Biotech/Biosimilar Product Stability Studies and Stability-Indicating Method Validation
    1. What are the requirements for biotech product stability studies during development and post approval?
    2. What is required to qualify vs validate methods that are claimed to be stability-indicating?
    3. Why can’t shelf life dates be extrapolated from accelerated stability data for biotech/biosimilar products?
    4. What are the critical elements to include in sound stability protocols for drug substance and drug product?
    5. What are the current expectations for extractable/leachable studies for biotech/biosimilar product container/closure interactions?
    6. What are the emerging expectations for subvisible and visible particle determination for biotech/biosimilar products throughout shelf life?
  5. Lab Quality Practices from R&D to GxP
    1. How much regulatory analytical data comes from R&D labs?
    2. What are the emerging expectations for lab quality practices for R&D labs, and how do they align with the principles of ICHQ10?
    3. What are the 6 key regulatory/compliance information packages expected from biotech/biosimilar analytical groups from R&D through GMP?
    4. What are the key similarities and differences among the current compliance expectations for GxP testing labs?
    5. What are the significant new expectations for quality agreements between contract testing labs and sponsors?
  6. Continuing Education Links Associated with Biotech CMC Analytical, Quality and Regulatory Issues

Meet Your Instructor

Nadine M. Ritter
Senior CMC Consultant at Biologics Consulting Group, Inc

Nadine M. Ritter,Ph.D., senior consultant for Biologics Consulting Group, Inc., is a protein chemist with expertise in the chemistry, manufacturing and control (CMC) of biotechnology products. She is past Director of Analytical Services Division at major contract testing organization performing R&D, GLP and GMP analytics studies. For over 15 yrs, she has contributed data to numerous US and international regulatory IND/IMP and BLA/NDA/MAA filings.

She also has considerable experience conducting audits of sponsor and contract laboratories worldwide. She is a member of several professional analytical organizations, and is frequently invited as a speaker and writer on analytical and stability issues.

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