Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products

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.

Section 1: Regulatory Requirements/Guidance on Analytical Method Validation

• Terminology defined: scientifically sound and appropriate, qualification, validation, revalidation and verification
• FDA, EMA, ICH and WHO requirements and guidance
• Validation lifecycle for analytical methods
• When during clinical development is analytical method validation required?

Section 2: Analytical Method Pre-Validation – Stage 1

• Analytical Target Profile (ATP)
• ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements

1. QC instrumentation qualification
2. Training
3. Critical assay reagent qualification

Section 3: Analytical Method Validation Characteristics – Stage 2

• Specificity, accuracy, precision, linearity, range
• LOD and LOQ
• Robustness and stability-indicating
• Value of system suitability controls

Exercise 1:  Quantitative Impurity ELISA (Host Cell Proteins)

• Detecting trace amounts of contaminating protein in a protein product
• Nature of the test method
• Intended use for the test method
• Review what others have done – in class activity

Section 4: Test Method Validation Protocol

• 8 basic elements of a validation protocol
• Pre-planning and planning steps
• Identification and documentation of assay characteristics needing to be validated
• Critical importance of assigning pre-defined acceptance criteria

Section 5: Validation Exercise:  Quantitative Potency Bioassay (Cell Lysis)

• Adequate bioassay development and optimization precedes validation
• Impact of physics, biology, chemistry and mathematics on bioassay performance
• Dilutional linearity
• Regression line analysis

Section 6: Test Method Validation Report

• 11 basic elements of the validation report
• Relationship of the validation protocol to the validation report
• Meeting the pre-defined acceptance criteria
• Handling deviations/OOS’s, when (not if) they happen

Section 7: Regulatory Authority Concerns About Test Method Validations

• Report card from the regulatory authorities on test method validation
• Validation issues identified during the review of the submitted market dossier
• Validation issues identified during regulatory inspections
• Test method validation “continuous improvement” – ICH Q10

Exercise 2: Nucleic Acid Amplification (Mycoplasma PCR)

• Inclusion specificity for rapid detection of adventitious agents
• LOD determination of mycoplasma contamination in bioreactors
• Universal DNA primer selection
• System suitability control selection

"This is the best course I’ve ever taken. It provided me with the knowledge I need to use immediately at work.."

Ximin C., Senior Scientist, enGene

"It was very intense for me, but in a good way!  The course material book was very thorough and contained all the information that was discussed during the course."

Romy V., Technician - Bioanalytics, uniQure Biopharma

"This course is a good start for anyone involved in cGMP assay development.  There was a lot of emphasis on method qualification during assay development in this course. Also, the course emphasized running a system suitability standard at various points on the Chromatographic assays instead of at the beginning and end."

Rassol L., Quality Control Manager, Akston Biosciences

"Great course.  The Course Director has a very organized structure for the course, and she addresses the key points in method validation. She obviously has a lot of practical experience/knowledge with method validation, such as FDA regulations, problems during the validations.  She clarified a few key confusing concepts during the method validation. She also could answer questions from the students with authority.”

Dr. Ming F., Sr. Raw Material Development Coordinator, Nitto Avecia

“The course was very complete. The Course Director was a great teacher and patient with our questions.  I enjoyed the levity during the presentation of the material, some of the concepts are easier to learn with a sense of humor.”

Joseph L., Sr. QC Scientist, Cell Therapies, Roche

"The printed set of Course Material was a bonus and I found the inclusion of some self-study sections very useful."

Marc B., Analytical Development Scientist, Cimeio Therapeutics

"For an online course, I was able to sustain my focus longer than I expected.  I enjoyed the challenging questions posed by the course director."

Stefan J., Analytical R&D, Alvotech

“Information and details shared during entire course was very helpful to understand analytical method validation as per FDA and other agencies.”

Ashishkumar P., Senior QC Analyst, Children's Hospital of Philadelphia

"Superior! It was exactly as advertised (unlike some I've taken with CFPA). Material was understandable although I am far from a technical expert."

Robert H., Sr. Research Scientist, Janssen

"This was my first Method Validation course but I have taken courses with other vendors. The scope of this course was very well laid out end to end and the handout materials will come in handy for years to come. Clear and concise validation with great examples!"

Brittany L., QC Specialist, Medicago

"Very experienced course director and provided great insights from her experience."

Sharmilapriya M., Process Engineer, MTA2

"The course was very useful for me and the course director was very helpful."

Wael M., Asst. Professor, King Saud Univ.

"Course was well paced and presented. The trainer was very knowledgeable and informative."

Brendan H., QC Scientist, BioMarin

"Very good course - exactly what I wanted and needed. A good broad range of examples; lots of real-life examples, both good and bad. I would recommend this course and the instructor."

Mark M., Sr. Res. Scientist, DPT Labs

"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