Biopharmaceutical Assay Essentials course

There are two parts for this course. Attend both parts of this course to gain a fundamental understanding of successful bioanalytical assay development and validation, or choose either part to focus on a particular topic or technology. This course is composed primarily of hands-on activities with some lecture.

Part 1: Focus on assay development and validation. During these two days, you'll acquire hands-on experience with designing and developing an ELISA. After assay optimization, the ELISA will be validated 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.

Part 2: Learn about analytical technologies used in biomanufacturing QC/analytical laboratories and get hands-on experience with HPLC, MALDI-TOF mass spectrometry, spectroscopy, and gel electrophoresis. In addition, you'll gain an appreciation for the various tools available for biopharmaceutical analysis.



  • Full four-day course: $2,420
  • Part 1 only (two days): $1,360
  • Part 2 only (two days): $1,360

NC State University 

Centennial Campus

850 Oval Drive

Raleigh, NC 27695