Vaccine CMC Regulatory Compliance and Quality Control


From Science to Approval - Understand the Complete Lifecycle of Vaccine Development

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Future Live Stream Sessions (click to register)

Course Overview

This 15-hour course guides you through the fundamentals of vaccine development—from the basics of vaccine microbiology and immunology to the development of the newest mRNA vaccines. Learn how FDA, CDC, and EU agencies regulate vaccines, including essential CMC and Quality requirements for development and approval.

 

Explore the bioprocess steps for bacterial, viral and therapeutic (cancer) vaccines, along with global Regulatory guidelines (FDA, ICH, WHO) and Quality Control strategies for various vaccine categories. Understand the specialized assays used for vaccine potency testing and gain insight into the landscape of COVID-19 vaccines, including mRNA production and testing.

Course Description

This course will introduce the attendee to the different types (classes) of vaccines and to the laws (PHSA, FD&CA) and regulations (ICH, FDA Guidances) required for vaccine development and production, testing and commercialization. The separate roles of FDA (CBER) and CDC in the US will be discussed and compared to vaccine regulation and policy in Europe. 

 

The basic bioprocess steps to produce bacterial and viral vaccines will be discussed with a focus on global Regulatory and Quality guidance (ICH, WHO) and FDA Guidelines of importance. Specific requirements imposed on vaccines by the Public Health Service Act (PHSA) and the Food, Drug and Cosmetic Act (FD&CA) will be discussed. Quality control testing for classes of vaccines will be presented with a focus on specialized tests for identify, quantity and potency. 

 

An overview of the elements of the immune system will be presented and immunological assays applied to certain vaccines in the measurement of quantity and potency will be highlighted. 

 

An overview of therapeutic vaccine development strategies and licensed vaccines regulated by CBER’s Office of Therapeutic Products will be presented, followed by a more in-depth look at vaccines developed globally to address the COVID-19 pandemic, with an examination of the unique production methods and drug product formulation requirements for the new class of mRNA vaccines and a view of the associated Quality Control testing of these products.

Why This Course Matters

The COVID-19 pandemic and current “triple-demic” of respiratory infectious diseases are shining a bright light on the vital public health need for developing safe and efficacious vaccines – and for organizations and individuals skilled in vaccine development and supply. Learning and experience from the rapid growth of the first wave of COVID-19 vaccines are being applied to the development of potentially more efficacious COVID vaccines. These technologies and additional established platforms are being applied to other infectious disease and therapeutic vaccine settings with renewed vigor as well. 

 

Understanding of vaccine CMC development and control strategies and of the applicable vaccine regulations and guidelines will be indispensable in this new surge of vaccine development by facilitating entry into the clinic and beyond and by avoiding BLA/MAA approval delays. 

Who Should Attend Vaccine CMC Regulatory Compliance Training?

 Ideal for leaders and professionals in Regulatory Affairs, Quality, Product/Process Development, Project Management, and business roles seeking to deepen their understanding of vaccine development and regulatory pathways.



Enhance your vaccine expertise—enroll today to confidently navigate CMC, regulatory, and quality essentials in this rapidly evolving field.

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  • Learning Objectives

    At the end of the three-day course attendees will:

    • Gain a solid understanding of the regulatory framework for vaccines for prophylactic (infectious disease) and therapeutic indications. 
    • Understand the structure of CBER within FDA and its historical evolution, and the processes in place in EU for review and authorization of new vaccines. 
    • Understand the fundamental bioprocess steps in production of bacterial and viral (cell-based) vaccines and control testing requirements/strategies, including a basic understanding of Master Cell Banks, Master Viral Seeds, upstream and downstream processes, and testing/characterization of process- and product-related impurities and adventitious agents.
    • Gain an understanding of the elements of the immune system and the use of basic immunological methods used in the quality control and characterization of vaccines.
    • Gain an understanding of the different types (classes) of prophylactic vaccines in commercial use, including live attenuated vaccines, inactivated bacterial and viral vaccines, subunits/toxoids, recombinantly produced vaccines and gene-based (mRNA) vaccines, and an understanding of approaches (vaccine types) being evaluated as potential therapeutic vaccines for conditions such as cancer.  
    • Understand the rapid development of COVID-19 vaccines through government funding (OWS, BARDA) and the current FDA requirements for Emergency Use Authorization (EUA) and full approval (BLA) of COVID-19 vaccines. Gain an understanding of different approaches undertaken by companies globally to develop COVID-19 vaccines and real-word safety experience and understand the quality control strategies applied to these vaccines.

  • Agenda

    Getting Started

    • What is a vaccine?
    • Types (classes) of vaccines
    • Vaccines in routine use – yesterday and today 
    • Vaccine regulation overview:  PHSA and the FD&CA. Why two sets of laws?  

    FDA Organization and Immunization Policy in the US; Comparison to EU

    • Current organization of CBER within FDA; Office of Vaccines Research and Review, Office of Therapeutic Products
    • Roles of CDC and ACIP versus FDA and VRBPAC in the US
    • Decentralized vaccination policy within the EU 

    Vaccine Production Overview – Basic Production Processes for Bacterial and Viral Vaccines 

    • Fundamental process steps for vaccine production
    • Upstream and downstream vaccine production processes – a high-level view 
    • Examples of manufacturing process flows for a bacterial conjugate vaccine and an inactivated influenza vaccine
    • Master Cell Banks and Master Virus Banks for vaccine production; ICH Q5B and Q5D, FDA Guidance on Viral Vaccines
    • Cell substrates used to produce licensed vaccines
    • Vaccine purity/impurities:  process related impurities, product related impurities and adventitious agents; regulatory and quality considerations; ICH Q5A    

    Requirements and Testing Strategies for Vaccines

    • Requirements imposed by PHSA and FD&CA
    • Review of 21 CFR 600-680 requirements pertinent to vaccines:  Biological Production Deviation Reports, establishment inspection and “Team Biologics”, VAERS reporting, vaccine lot release
    • Biological potency vs. potency of small drugs; examination of potency tests employed for different classes of vaccines  
    • Requirements for vaccines and other drugs alike:  21 CFR 200s, 300s, and more 
    • Overview of ICH Guidelines and companion FDA Guidance relevant to vaccine development
    • Examination of ICH Q6B (Test Procedures and Acceptance Criteria) as applicable to vaccines
    • Examination of typical QC release testing plans for vaccines (bacterial, viral/cell culture based)  

    Basic Vaccine Immunology

    • Elements of the immune system: innate and adaptive immune systems
    • Measuring the immunological response to a vaccine in potency assays:  serum neutralization, antibody titer by ELISA
    • Other immunological tests for vaccines:  Lf test to quantitate toxoids, SRID for flu vaccine potency 
    • Adjuvants:  purposes, classes of adjuvants in vaccines; regulatory assessment of novel adjuvants (EU Guidance)   

    Therapeutic Vaccines

    • Distinction between therapeutic and prophylactic vaccines
    • Approaches to development of therapeutic vaccines for cancer: some hits and misses so far 

    A Focus on COVID-19 Vaccines: Vaccine Development Approaches to the Pandemic

    • Overview of SARS-CoV-2 virus and COVID-19 disease; recent history; development of “variants”
    • Operation Warp Speed funding of vaccine development; BARDA
    • FDA Guidance on development of COVID-19 vaccines
    • Vaccine development approaches:  inactivated whole viruses, subunits, mRNA, DNA, viral vectors 
    • A deeper look at mRNA vaccines:  the basic science of this new vaccine approach; structure of mRNA vaccines, in vitro transcription production, nanoparticle formulations
    • QC strategies applied to mRNA vaccines

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.