Quality Assurance/Quality Control for Biologics and Biopharmaceuticals

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    "The Course Director has impeccably presented a big load of information over 3 days, showing deep knowledge based on experience. He is a natural communicator, and his commitment to deliver a clear message within a tight time schedule confers him an empathetic character. It has been a pleasure to take this course."  


    Veronica F., QC Supervisor, WGTU, University College London Cancer Institute

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    "The Course Director put a great deal effort into producing an outstanding course. I would recommend this course to all of my colleagues."


    Jeffrey M., Sr. Information Technology Analyst, Biogen

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    "The fact that this company limits the class size allows the Course Director to tailor the material to those in attendance. It was obvious that a lot of preparation went into addressing our needs. Needless to say, the instructor was very experienced and did a great job."


    Amy C., Genentech

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    "Probably the most specifically appropriate and pertinent course I have ever attended."


    Senior Drug Information Manager, Bristol Myers

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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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Course Brochure

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Course Description

Biologics are different from chemical drugs because of: (1) they derive from living source materials, (2) biologic manufacturing processes are generally more complex, (3) biologic molecules themselves are much more complex and are often not easily characterized (4) biological molecules cannot be purified by simple recrystallization and (5) biological drug products cannot be terminally sterilized in the final container. While chemical drugs can become generics, biologics products are almost impossible to copy precisely and are therefore considered as “biosimilars”, and not as “bio-generics”. 


Biologics are highly susceptible to adventitious agent contamination – prions, viruses, mycoplasmas, and bacteria/fungi microbes. Risk control procedures – such as prevention of adventitious contamination, testing to confirm absence, and inactivation/removal – are essential and form a significant part of the process control strategy. Lessons can be learned from reported contaminations of biologic manufacturing processes. Compared to chemical drugs, biologics have a more complex process-related impurity safety profile, especially due to the living system-related impurities (e.g., host cell proteins, host cell DNA).


Extensive physicochemical characterization of the molecular structure of proteins and monoclonal antibodies, employing multiple, complementary, as well as orthogonal, state-of-the-art analytical methods is necessary. These methods cover primary amino acid sequence changes (e.g., truncation, deamination, oxidation), post-translational modifications (e.g., glycosylation), and higher order structural changes (e.g., secondary folding, aggregation). Because of the molecular structural complexity of a biologic, including its many possible structural variants, functional activity assays are normally required that can discern which structures have what amount of potency. While bioassay functional activity assays (i.e., in vivo, in vitro) are required for measuring potency, surrogate (analytical) assays can be used if properly correlated to the bioassays. An assay matrix is often required. Many manufacturers underestimate the amount of resources and time needed to develop, implement and validate these functional activity assays.


This course will help the attendee to develop an effective QA/QC quality risk management strategy for biologics, addressing the quality challenges starting at the pre-clinical material, through Phase 1 clinical studies to commercialization. Guidance from the FDA, EMA and ICH will be discussed. In addition, the differences in managing quality for chemical drugs vs. biologics will be examined.


Who Should Attend

This 15-hour course is designed for management and professional and technical staff involved in, or interested in quality assurance (QA) and quality control (QC) support for biologics and biopharmaceuticals. This course will be of particular interest to QA and QC personnel and management, Regulatory Affairs Professionals, Manufacturing, Process Development and Analytical Development staff, and anyone involved with the biologic and biopharmaceutical industry.

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  • Learning Objectives

    At the end of the course you will:

    • Understand the critical importance and underlying principles for the QA/QC of biologics and biopharmaceuticals, and know how these principles differ from those for chemical-origin drug products
    • Be able to develop a clinical-phase appropriate, cost-effective strategy to effectively manage the quality lifecycle through clinical development into commercialization of diverse biologic/biopharmaceutical manufacturing processes and products, including live-vaccines, and gene and cell therapies
    • Be able to establish effective inter-company quality agreements with outsourced contractors
    • Have the tools and understanding necessary to adequately address biosafety (adventitious agents), potency (biological functioning bioassays) and impurity profile issues for biologic and biopharmaceutical products; and how to set appropriate and adequate product specifications and expiration dates

  • Agenda


    Introductions and Course Objectives


    Why are Biologics Different?  What are the Differences and What are the Regulatory Background and Expectations?


    The Role of QA/QC in Biologics Processes – Phase Appropriate GMP Presentation and Interactive Session


    Developing a Corporate Quality Strategy for Biologics - Process Understanding, Quality by Design (QbD) and Quality Risk Management 


    Group Exercise – Defining a Process Control Strategy - Interactive Group Session


    Group Exercise – Current Hot Topics


    Facility Design and Control


    Group Exercise – Environmental Control Strategy - Interactive Group Session


    Control of Adventitious Agents – What are Adventitious Agents?  Sources of Adventitious Agents and their Control


    Group Exercise –Control Strategy for Adventitious Agents -  Interactive Group Session


    Biological Characterization and Specification Setting - Presentation and Interactive Session


    Impurity Profiles – Small versus Large Molecules – Process- and Product-Related Impurities and How to Control Them


    Dealing with Things that go Wrong – Deviations, OOS, Root Cause Analysis and CAPA, Continuous Improvement Programs


    Analytical Method Development, Method Transfer & Validation - Clinical to BLA

     

    Data Integrity and Document Control


    Stability Testing Managing Stability Programs – What, When and How? – Setting Shelf Lives and Expiration Dating - Presentation and Interactive Session


    Process Validation and Process Performance Qualification (PPQ) - Presentation and Interactive Session


    Group Exercise – Planning the PPQ – The Role of Quality Control - Interactive Group Session


    Outsourcing – Vendor Selection, the Requirements for the Contract Giver’s Quality Management System - Presentation and Interactive Session


  • Testimonials

    "The small group size and great material made the content very useful. The instructor was awesome and did a great job with the  virtual course delivery."

    Susan H., Lab Manager, Keystone Labs


    "Course content was interesting and more thorough than with other training providers. Real world examples of what not to do were very helpful."

    Katrin M., QA Specialist, Teva Pharmaceuticals


    "The course was well organized and was provided in a clear, concise fashion. I found the specifics on analytical techniques and stability to very informative."

    Joseph C., QC Manager, Incyte


    "This course covered a lot of information and lessons to learn from, as well as advice and suggestions for different QA/QC aspects and approaches."

    Theodora M., QA Manager, Solid Biosciences


    "The Course Director has impeccably presented a big load of information over 3 days, showing deep knowledge based on experience. He is a natural communicator, and his commitment to deliver a clear message within a tight time schedule confers him an empathetic character. It has been a pleasure to take this course."

    Veronica F., QC Supervisor, WGTU, University College London Cancer Institute


    "The Course Director showed a clear mastery of this incredibly complex area of product development manufacturing and regulatory compliance. Nice job! Very personable, good content - will take a while for everything to sink in."

    Dr. Matt H., Scientist QA, Promega


    "The course was very effective in presenting regulatory issues. The instructor was very knowledgeable and discussed real-life situations."

    Steve R., Drug Information Specialist, Organon


    "The Course Director put a great deal effort into producing an outstanding course. I would recommend this course to all of my colleagues."

    Jeffrey M., Sr. Information Technology Analyst, Biogen Idec


    "The fact that this company limits the class size allows the Course Director to tailor the material to those in attendance. It was obvious that a lot of preparation went into addressing our needs. Needless to say, the instructor was very experienced and did a great job."

    Amy C., Genentech


    "Probably the most specifically appropriate and pertinent course I have ever attended."

    Senior Drug Information Manager, Bristol Myers


    "This course was much better than others I attended and I would strongly recommend this course to others."

    Dr. Shahid A., VP of Research & Development, NeoPharm

FAQs

  • Does the course cover both biologics and biopharmaceuticals in clinical development as well as market-approved?

    The course covers the Quality Assurance (QA) and Quality Control (QC) requirements and expectations for biologics and biopharmaceuticals in clinical development (i.e., Phase 1 to Phase 3 studies) as well as those having market approval.

  • Does the course cover FDA and international concerns?

    The course covers all aspects of QA and QC requirements and guidance for biologics and biopharmaceuticals from the FDA, European Medicine Agency (EMA), and International Conference on Harmonisation (ICH).

  • How does this course differ from the course CMC Regulatory Compliance for Biopharmaceuticals and Biologics™?

    This course focuses on all aspects of keen interest to quality assurance and quality control, including control systems and setting of specifications and expiry dating for biologics and biopharmaceuticals. On the other hand, the CMC Regulatory Compliance course systematically covers all aspects of CMC regulatory compliance concerns, including areas of keen interest to regulatory affairs, manufacturing and development for biologics.

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.