Attend this course to gain a fundamental understanding of successful bioanalytical assay development and validation. This course is composed of primarily hands-on activities with some lecture. You’ll get hands-on experience with designing and developing assays, then validating them by considering ICH guideline Q2(R1). You’ll gain an appreciation for the complexities involved in biopharmaceutical analysis and learn about troubleshooting, data analysis, and experimental design. You’ll also gain a fundamental understanding of analytical technologies used in biomanufacturing QC/analytical laboratories and get hands-on experience with spectroscopy, electrophoresis (gel and capillary), U/HPLC, MALDI-TOF mass spectrometry, and ESI liquid chromatography-mass spectrometry. In addition, you’ll gain an appreciation for the various tools available for biopharmaceutical analysis.

June 22 – 24, 2027

$3,100 registration fee

Register

Attend and you will learn 

• Fundamentals of common bioanalytical techniques. Understand the principles and applications of major bioanalytical techniques, including plate-based assays, electrophoresis, analytical chromatography, and mass spectrometry.
• How to perform specific practical assays. Learn how to perform specific assays such as ELISAs, protein sizing, peptide mapping, purity assessment, as well as basic operations of common analytical equipment, such as CE, U/HPLC and MS.
• Bioanalytical method development and validation principles. Grasp the essentials of method validation, including designing experimental plans and understanding parameters like specificity, linearity, precision, accuracy, and limit of detection (LOD).

Schedule

Day 1	Lectures • Introduction to Biopharmaceutical Quality Testing • Analytical Assays in Biopharma • Pipetting Techniques and Calibration Curves • Protein Quantification with Plate-Based Assays (Part 1 – Total Protein) • Principles of Method Validation in Biopharma • Protein Quantification with Plate-Based Assays (Part 2 – Target Protein) Lab Activities • Skills Lab – Pipetting Techniques • Total Protein Quantification with BCA/Bradford Assays • Total Product Quantification with Direct ELISA Workshops • Data Analysis: Building Standard Curves and Calculating Total Protein • Data Analysis: Applying Validation Principles
Day 2	Lectures • Identity and Purity Analysis with Electrophoretic Techniques • Identity, Purity and Aggregate Analysis with High-Performance Liquid Chromatography (HPLC) Lab Activities • Product Size and Purity Assessment with Gel and Capillary Electrophoresis • Product Quantification, Purity Assessment, and Aggregate Analysis with Reversed-Phase and Size-Exclusion HPLC Workshops • Data Analysis: Calculating Product Concentration and Validating ELISA Results • Data Analysis: Determining Product Identity and Purity from Gel Band Pattterns and Electropherograms
Day 3	Lecture • Advanced Product Characterization (identity, sequence, purity profile) with Mass Spectrometry Lab Activities • Product Characterization with Matrix-assisted Laser Desorption Ionization (MALDI) and Liquid Chromatography-Mass Spectrometry (LC-MS) Workshops • Data analysis: Determining Product identity, Purity, and Concentration from Chromatograms • Data analysis: Confirming Product Identity, Sequence and Purity from Mass Spectra • Systematically Designing Analytical Methods: An HPLC Workshop
	*Subject to change

Who should attend

• Professionals new to the biopharmaceutical industry or entering new work assignments encompassing analytical or QC environments
• Professionals with previous QC/analytical experience who want to learn new techniques and/or broaden their understanding

Instructors 

• Cyndell Gracieux-Singleton, Ph.D.
• Greg Buhrman, Ph.D.