Content

Biopharmaceutical Assay Essentials

Delivery methods

Course content

analytical course

Special Topics

This course can count toward your Professional Certificate in Biomanufacturing Science.

Why should you attend?

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.

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).

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

Attend and you will receive

  • 22.5 hours of instruction
  • Digital course materials
  • Morning coffee and tea
  • Lunch
  • Afternoon beverage break
  • Certificate of completion

Instructors

Fee

  • $3,100

Important Information for In-person Course Participants

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