Course Description:

Analytical methods ensure quality of drugs and biologics. During last 2 decades, paradigm for quality of pharmaceutical products has shifted from ensuring quality by testing representative samples to building quality during manufacture of such products, leading to the concept of Quality by Design (QbD). This course starts with discussing the new paradigm of quality, QbD, and role of analytical methods in ensuring quality.

Methods play a critical role in development and manufacture of drugs and biologics and should be considered as a "Life Cycle" approach throughout the life cycle of a pharmaceutical product. The methods must be suitable for intended purpose during different stages of development and for commercial manufacture of the product. Understanding regulatory expectations and requirements for the methods is important to develop and design methods that are not only suitable for intended purpose, but support manufacturing operations in release of the product in a timely manner. All methods used in manufacturing operations must be maintained in a compliant state with acceptable method performance during life cycle of the product. This course will go into details of the life cycle of analytical methods, including verification, qualification and validation of methods for various stages of product development and for various purposes during manufacturing operations. Appropriate methods attributes and parameters will be discussed that need to be monitored (tracking and trending) to evaluate method performance.

Biologics products being complex and of biological origin, often require biological methods to release starting materials, intermediates and final product. Biological methods or bioassays with large inherent variability have challenges in developing appropriate method so that these are suitable for intended purpose. Focus on science and regulatory expectations during product development is essential to develop appropriate biological methods. This course will further go into the challenges, regulatory expectations and myths about bioassays with focus on developing suitable bioassays for intended purposes.

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

One of the challenges in developing cutting edge products, including cellular, tissue, gene therapy products, vaccines and blood products is developing appropriate potency method for these products. Often protective mechanisms for such products or surrogate markers for efficacy of such products are not clearly defined. There are examples of use of highly variable animal based methods as potency tests, which are sometimes poor indicators of human efficacy. In such cases, the concept of consistency in manufacture is employed to develop appropriate potency test, which may be a single test or a combination of tests. This course will go through regulatory expectations in developing potency tests for biological products.

Critical Reagents, Reference Standards and Internal controls play an important role in ensuring validity of results generated by analytical methods, particularly biological methods, and also to ensure acceptable performance of the method over time. This course will also discuss about selection and qualification of critical reagents, reference standards and internal controls for generating reliable results.

Throughout the course, specific examples with regard to achieving regulatory compliance during inspections, audits and review of methods sections, as part of license applications or supplements to license applications will be discussed. More importantly, information on the design of robust methods "Suitable for Intended Purposes" will be provided to mitigate risks of mistakes/errors and out of specification (OOS) results.

At times, it may be required to modify or change a method or a specification for a product. Appropriate validations and comparability studies are required to have these changes accepted by regulatory agencies. Ways to make these changes that are acceptable to regulatory agencies and are effective in manufacturing quality products will be discussed in this course.

Learning Objectives:

Upon completing this course the participants will understand:

  • Ensuring quality by the new paradigm of Quality by Design(QbD)
  • Building quality in the product
  • Analytical Method Life Cycle during Product Development and commercial Manufacturing
  • Regulatory Expectations and Requirements for the Methods during Product Development
  • Methods Verification, Qualification and Validation with Examples
  • Methods Validation Characteristics – Robustness, Specificity, Accuracy, Precision, Linearity, Limit of Detection, Limit of Quantitation, Range
  • Tracking and Trending of Method Performance
  • Challenges with Biological Methods or Bioassays
  • Myths and Regulatory Expectations about Bioassays
  • Potency Tests for complex Biological Products
  • Regulatory Expectations for a Potency test
  • Role of Critical Reagents, Reference Standards and Controls and their Development and Qualification
  • Risks and Inherent Variability of Analytical Methods
  • Designing Methods “Suitable for Intended Purposes” to Mitigate Risks due to Errors and Out of Specification (OOS) Results
  • Changes to Approved Methods – Change Control, Comparability Protocols
  • How to Continuously Monitor Method Performance and achieve sustainable compliance of methods for regulatory requirements?

….much, much more

Who Will Benefit:

  • Pharmaceutical Industry
  • Biotech Industry
  • Managers and Scientists involved in Drug Development
  • Analytical Development Scientists involved in method development, qualification and validation of methods
  • Quality Control Scientists Involved in Performing Routine Testing and Monitoring Method Performance
  • Quality Assurance Staff for Informed Review of Data and for Managing and Providing Oversights on Investigations, Change Control, etc.

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

Introduction – Ensuring Quality by Testing Representative Samples and Building Quality in the Product

  • New Quality Paradigm
    • Shift from “Final Testing” on Product to “Build Quality” in the Product during Manufacture
  • How to Build Quality in the Product?
    • Good Manufacturing Practices (GMP)
    • Quality by Design (QbD)
    • Process Analytical Technologies (PAT)
  • What do you get by Building Quality in the Product?

Role of Analytical Methods in Ensuring Quality

  • Critical in Assuring Quality for both Conventional and New Paradigms
  • Analytical Methods in Ensuring Quality by Testing Representative Samples
    • Manufacturing
    • Release Testing
    • Stability Testing
    • Consistency in Manufacture
  • Analytical Methods in QbD
    • Identifying Starting/Raw Materials & CPP affecting Quality
    • Identifying CQAs
    • Designing Process and Defining Design Space
    • Implementing PATs
    • Analytical Methods, Probes, Chips, etc.

Analytical Method Life Cycle during Product Development

  • Selection, Design, Development/Optimization, Validation
  • Characterization Tests
  • Qualification versus Validation
  • Method Verification
  • Method Qualification
  • Method Validation
    • Review of Definitions
    • ICH/FDA Guidelines
    • Examples for Effective Method Validation Studies
  • State of Analytical Methods with regard to Development/Qualification/Validation
    • Pre-Investigational New Drug (IND)
    • IND (Clinical Development)
    • Pre-BLA (Biologics License Application), BLA
    • Inspections

Challenges in Developing Testing Criteria for Biological Products

  • Complexity of Biological Products
    • Made from Starting Materials that are Biological in Nature
    • Thorough Characterization of Starting Materials for Inherent and Adventitious Agents
    • Require Aseptic Manufacturing Process
    • Risks of Tumorigenicity (Continuous cell lines & Adventitious Agents), and Teratogenicity
    • Risk of Impurities (Immunological & Toxic)

Biological Methods or Bioassays – Regulatory Expectations, Myths

  • Role in Development and Manufacture of Biological Products
  • Challenges in Development and Validation
  • Misconceptions
  • Example of Understanding Science
  • Importance of Method Design for “Intended Use”
  • Considerations for Bioassay Validations

Potency Test for Complex Biological Products

  • Biological Products & Potency Test
    • Animal Based Potency Tests
  • Potency Tests
    • Definitions, Regulations, Guidelines, Views
  • Paradigm Shift
    • Lot Release Testing to Consistency in Manufacture
  • Alternate Potency Methods
    • Physico-Chemical Methods
    • Immunochemical Methods
  • Suitability of Potency Method for “Intended Purpose”

Inherent Method Variability in context of Design of a method that is “Suitable for Intended Purpose”

  • Normal Distribution, Understanding Variability
  • Example of Managing Variability with Appropriate Method Design

Critical Reagents, Reference Standards and Internal Controls

  • Definitions
  • Development and Qualification

Monitoring of Method Performance – Tracking and Trending

  • Overview of Critical Quality Attributes
    • Relation to Quality
    • Identifying CQAs
    • Examples
    • Key Performance Attributes
  • Trending and Tracking
    • Selection of Attributes and Parameters
    • Periodic Reviews
    • Actions

Change Control for Changing Methods, Comparability Protocols

  • History and Need for Change Control
  • FDA Regulations for Change Control
    • What is Required for Making a Change?
    • Pre-Approval Supplement
    • Changes Being Effected (CBE) & CBE – 30
    • Changes in Annual Report

Meet Your Instructor

Rajesh Gupta
Visionary Scientific & Compliance Consultant and Former Deputy Division Director and Lab Chief, Div of Product Quality, FDA CBER

Rajesh K. Gupta has a Ph.D. in microbiology and is the Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years' experience in the development, production, testing and regulation of biologics, working at both the regulatory agencies and the industry.

At FDA, CBER, he was a Deputy Director and the Lab Chief in the Division of Biological Standards and Quality Control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods.

In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH), in the USA and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in sterility assurance for biological products, adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and has made numerous presentations at scientific and regulatory meetings.

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