E13 – Quantitative Lab Skills for the Modern Analyst

Quantitative Lab Skills for the Modern Analyst

NEW One-Day Course, E13-18, Monday, November 18th, 8:30am – 5:00pm

 Dr. Merlin Bicking, ACCTA, Inc., St. Paul, MN

Explanations of the properties of proteins that must be characterized in the course of developing a protein therapeutic drug and monitored during production and lot release begin this class. The theory and practice of a number of chromatographic separation techniques that play key roles in the analysis and characterization of protein therapeutic drugs are then described. The chromatography techniques that are discussed include reversed-phase HPLC, ion exchange, size exclusion and several less well-known techniques in chromatography. Examples of how these are used in the development and release of protein therapeutic drugs are shown.

 This course is designed for new laboratory staff – either recent graduates or transfers from other non-analytical groups, especially those who have never completed a quantitative analysis course, specialists who want to add new skills or need cross-training instruction, and experienced analysts and technicians who want or need a brief refresher course.  Anyone needing the “education, training, and experience or any combination thereof…” to work in a GMP environment.

1. Mathematical Skills: A Review
     * Perspectives
     * Units, units conversions and calculations
     * Chemical factors
     * Significant figures and rounding
     * Method-related calculations
     * Pegylation and other forms of conjugation
2. Using Laboratory Equipment:  Avoiding the Most Common Problems
     * Analytical Balances
     * pH Meters
     * Filtration
3. Volumetric Containers:  Why We Do What We Do
     * General issues with Volumetric Glassware
     * Specifications and calibrations
     * Volumetric flask and pipets
     * Pipetting instruments (pipetters) 
4. Solution Preparation Issues:  Putting It All Together
     * Propagation of errors
     * Preparation of solutions and standards
     * Should I choose a parallel or serial dilution scheme
     * Documentation and observation

Dr. Merlin K. L. Bicking is President, ACCTA, Inc.  He has extensive analytical chemistry experience in academia, contract research, independent testing laboratories, consulting, and technical training.  His professional history includes development of two EPA methods, as well as numerous methods in other regulated and non-regulated industries.  His publications and presentations cover a wide range of topics, including liquid chromatography theory, derivatization, method optimization, and the use of experimental design strategies in analytical chemistry.  He also develops and presents technical training seminars for analytical laboratory staff.