Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products™

Course Description

Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex QC test methods to confirm manufacturing consistency and product quality. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies. The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays.

Who Should Attend

This two-day course is designed for those who perform, supervise, manage, audit, or oversee the validation of test methods for the quality control of biologic and biopharmaceutical products. This includes, but is not limited to, professionals in Analytical Development, Quality Control, Quality Assurance, and Validation groups. The course will also benefit those in other departments who find test method validation among their responsibilities.

While the course focuses on test method examples for biologics and biopharmaceuticals, the principles and practices of test method validation taught in this course are universal for all therapeutic pharmaceutical products.

Learning Objectives

Upon completion of this course, attendees will have a clear understanding of international regulatory authority regulations, and expectations and will have gained the background knowledge necessary to effectively plan and execute QC test method validation programs. Participants will have gained expertise in writing test method validation protocols and reports and in setting acceptance limits for validation. Additionally, attendees will have acquired insight into how to avoid common validation pitfalls and be able to quickly discriminate compliant from non-compliant test method validation activities.

Past Participants' Comments

"I loved the course. The pace was perfect, the organization of the content was incredible. The course director was knowledgeable and articulate. Most impressive is the fact that he presented the subject with both points of view – industry and regulating agency – clearly and objectively at the same time." Hoai C., Pharmacologist, FDA

"This was the best course that I have taken! I really appreciated the exercises; more courses should include these types of applications." David D., Interim Director, UNC Vector Core

"Great course! You did a really good job of making dry subject material very interesting. You really held my attention during the whole course. It was a good mix of discussion and lecturing." Sonya S., Analytical Scientist, Micromet

"Excellent presenter who made the topic both interesting and informative through interaction with the class, many excellent tips, suggestions and references were provided. Much of the mystery surrounding test method validation was explained and clarified. The course notes will prove to be an excellent reference source." Douglas R., Manager R&D, QA GMP Compliance, Sanofi Pasteur

"The Course Director was engaging and kept our attention well. Exercises were appropriate and helpful to understanding the material. This course was very helpful to me as a Quality representative that will be providing guidance and validation requirements." Christine E., Assoc. Director, Venture Quality, Janssen R&D

"This course was very useful. I walked in not knowing anything about test method validation, but walked out with good information to introduce to my company. The course director was very interesting, smart, realistic, very knowledgeable about regulations and common problems companies face. The content of the course is very useful and interesting with the examples provided." Rania, QA Engineer, Integra LifeSciences

"This course provided the road map to methods validation (through the course material) that is often hard to find elsewhere in guidance documents, forums, etc." Mike D., Senior Scientist, Johnson & Johnson

"Excellent course!! The Course Director is very knowledgeable and provided very clear educational materials with representative examples." Jian H., Sr. Research Chemist, Merck

"This course was an excellent background on method validation." Mark C., Validation MGR, OPTI Medical Systems

"The course director was good at letting good discussions run and that can be most helpful. He made us think and answer the in-class questions, which was a good idea. It will help me remember the material." John G., Research Scientist, Talecris Biotherapeutics

"This was one of the most interesting and helpful training courses I have ever taken. The course director is very interesting and engaging." Tamiru B., Alexis

"The course director had excellent presentation and communication skills. He was knowledgeable of the topics presented and he was able to answer all of the questions asked. Great Job!" Tomas T., Associate Scientist, Merck

Frequently Asked Questions

How much of the course deals with method validation for chemical drugs versus biologics?

The course covers all aspects of analytical method validation with common principles applicable to chemical drug and biologic testing. Case examples that are worked on in class are based on biologic product testing. Being able to manage analytical method validation for biologic product testing is much more demanding than analytical method validation for chemical drugs.

Does the course cover FDA and international concerns?

The course covers all aspects of analytical method validation including requirements and guidance from the FDA, European Medicine Agency (EMA), World Health Organization (WHO) and International Conference on Harmonisation (ICH).

I am new to validation. Will I understand what is being presented?

The course systematically covers all aspects of analytical method validation, and leads the attendees from the basics of method validation to the application of validation principles to difficult assays such as bioassays and process-related impurity ELISAs.

How is this course different from the course on Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays™?

This course is focused on analytical method validation of chemical drug and biologic product release and stability testing assays used in a current good manufacturing practice (cGMP) environment. On the other hand, the Bioanalytical Assay Validation course focuses on method validation for assays used in testing animal and human serum and tissue samples used in a good laboratory practice (GLP) or good clinical practice (GCP) environment.