E24: Analytical Target Profile (ATP): An Introduction and its Strategic Link to Quality Target Product Profile (QTPP) and Analytical Life Cycle Management (ALCM)

One-Day Course
Date to be Announced; 8:30am – 5:00pm
Partha S. Mukherjee, Amicus Therapeutics, Princeton, NJ

Quality by design (ICH Q8) describes the Quality Target Product Profile (QTPP), which forms the basis for the design and development of the product. An analogous analytical term is called the Analytical Target Profile (ATP). ICH Q14 defines ATP as a method attribute that prospectively summarizes the analytical requirements of a Critical Quality Attribute (CQA). This course will present how ATP ensures method fitness for CQA with optimal bias and precision, through the product life cycle. The link of ATP to QTPP, Total Analytical Error, Critical Method Attribute and Factor, Quality Risk Management, Quality by Design, DOE, and Method Operating Design Region will be explained.

Pharmaceutical professionals in development and commercial analytical functions, who would like to learn how ATP should be incorporated in methods to ensure commercial robustness. It will be relevant for regulatory professionals who would like to pursue how ATP can introduce post approval change flexibility. This is useful for CMC professionals who would like to gain more insight on how to implement an end-to-end CMC control strategy for products. This is also relevant for quality professionals who will need to gain knowledge of how ATP can be used for quality control of products.

1. Definition of ATP as per ICH Q14 and USP <1220>
2. Analytical method expectations and ATP
3. Drafting an ATP: information gathering
4. How ATP concept can be leveraged
5. Total Measurement Uncertainty (TMU) and ATP
6. ATP Examples
7. Link of QTPP, Post approval changes, Analytical Control Strategy (ACS) with ATP
8. Link of Critical Quality Attribute (CQA), Critical Method Attribute (CMA), Critical Method Factor (CMF), Design of Experiment (DOE), Total Analytical Error (TAE) with ATP
8. Link of Analytical Life Cycle Management (ALCM), Quality Risk Management (QRM), Method Operating Design Region (MODR) with ATP

Dr. Partha S. Mukherjee has extensive experience (27+ years) in Pharmaceutical CMC Development arena in Life Cycle Management from Discovery through branded, generic, and OTC product commercialization. Strong track record in Technical and Organizational Leadership, Quality (Control & Assurance), CMC, and People Management. Broad expertise in various Analytical and Bio-analytical Separation Science techniques and instrumentation for Small Molecules, Antisense Oligonucleotides, Biologics, Hemi Synthetics, Radiopharmaceuticals, and Cell and Gene Therapy (CGT) Products. High energy level, strong take-charge ability, and follow through. Demonstrated leadership skills in innovation, strategic thinking, passion for customers, developing others, collaborative working, and driving performance of the organization.  Analytical leadership in 6 of top 10 global pharmaceutical companies in all major Therapeutic Areas and covering all key dosage forms. Member of USP Small Molecule Medicines Expert Committee, BioPhorun, and WHO Technical Reviewer. Built several Analytical Centers of Excellence in major pharmas.