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
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.

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
  • 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

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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Local Attractions

The Grand Palace is a complex of buildings at the heart of Bangkok, Thailand. The palace has been the official residence of the Kings of Siam (and later Thailand) since 1782. The king, his court and his royal government were based on the grounds of the palace until 1925. The present monarch, King Bhumibol Adulyadej (Rama IX), currently resides at Chitralada Royal Villa in the Dusit Palace, but the Grand Palace is still used for official events. Several royal ceremonies and state functions are held within the walls of the palace every year. The palace is one of the most popular tourist attractions in Thailand.

Wat Phra Kaew is regarded as the most sacred Buddhist temple (wat) in Thailand. The Emerald Buddha housed in the temple is a potent religio-political symbol and the palladium (protective image) of Thai society. It is located in Phra Nakhon District, the historic centre of Bangkok, within the precincts of the Grand Palace. The Emerald Buddha, a dark green statue, is in a standing form, about 66 centimetres tall, carved from a single jade stone. Except for the Thai King and, in his stead, the Crown Prince, no other persons are allowed to touch the statue.

Khaosan Road or Khao San Road is a short street in central Bangkok, Thailand. It is in the Banglamphu area of (Phra Nakhon district) about 1 kilometre north of the Grand Palace and Wat Phra Kaew. "Khaosan" translates as "milled rice", a reminder that in former times the street was a major Bangkok rice market. In the last 20 years, however, Khaosan Road has developed into a world famous "backpacker ghetto". It offers cheap accommodation, ranging from "mattress in a box" style hotels to reasonably priced 3-star hotels. It is also a base of travel: coaches leave daily for all major tourist destinations in Thailand, from Chiang Mai in the north to Ko Pha Ngan in the south. Khaosan shops sell handcrafts, paintings, clothes, local fruits, CDs, DVDs, used books, plus many useful backpacker items. During late evening, the streets turn into bars and music is played, food hawkers sell barbecued insects, exotic snacks for tourists, and there are also locals flogging ping pong shows.

Siam Paragon is a shopping mall in Bangkok, Thailand. It is one of the biggest shopping centres in Asia. It includes a wide range of specialty stores and restaurants as well as a multiplex movie theatre (consisting of 15 large size theaters with one of them recognized as having the biggest screen and seating capacity in Asia) and the Sea Life Ocean World (underwater world) aquarium (the largest aquarium in South East Asia) and an exhibition hall and the Thai Art Gallery and also an opera concert hall. It also has a large bowling alley and karaoke centre.

Wat Arun Ratchawararam Ratchawaramahawihan or Wat Arun, "Temple of Dawn", is a Buddhist temple (wat) in Bangkok Yai district of Bangkok, Thailand, on the Thonburi west bank of the Chao Phraya River. The temple derives its name from the Hindu god Aruna, often personified as the radiations of the rising sun. Wat Arun is among the best known of Thailand's landmarks and the first light of the morning reflects off the surface of the temple with pearly iridescence. Although the temple had existed since at least the seventeenth century, its distinctive prang (spires) were built in the early nineteenth century during the reign of King Rama II.

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