Biopharmaceutical Assay Essentials
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.
| Dates | Course | Cost | Registration |
|---|---|---|---|
| May 12-13, 2026 | Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation | $1,500 | Register |
| May 20–21, 2026 | Hands-On Essentials of Automation for Biomanufacturing | $2,050 | Register |
| May 27–29, 2026 | Preparative Chromatography Column Packing: Lab to Process Scale | $2,500 | Register |
| June 3–4, 2026 | Applied Cleaning Validation Practices: A STERIS Master Class | $2,000 | Register |
| June 9–10, 2026 | Introduction to Biopharmaceutical Lyophilization | $1,975 | Register |
| June 11, 2026 | Essentials of Spray Drying and Powder Analysis | $995 | Register |
| June 16–18, 2026 | Fundamentals of Mammalian Cell Line Development | $3,100 | Register |
| June 23–25, 2026 | Biopharmaceutical Assay Essentials | $3,100 | Register |
| June 23–25, 2026 | Fermentation Engineering | $3,100 | Register |
| June 30–July 2, 2026 | Hands-On Principles of mRNA Technology | $2,500 | Register |
| July 8–10, 2026 | Downstream Biopharmaceutical Processes: Fundamentals and Design | $3,100 | Register |
| July 14–16, 2026 | AAV Quality Attributes: Theory and Practice | $2,975 | Register |
| July 14–17, 2026 | Hands-On cGMP Biomanufacturing Operations | $4,200 | Register |
| July 28–31, 2026 | Hands-On Biomanufacturing of Vectors for Gene Therapy | $4,500 | Register |
| Aug 6, 2026 | Design of Experiments for Biomanufacturing | $500* | Register |
| Sept 29–Oct 1, 2026 | Cell Culture Engineering | $4,200 | Register |
| Oct 13–16, 2026 | Applied Principles and Techniques of Depth Flow Filtration (DFF) and Tangential Flow Filtration (TFF) for BioPharm Purification | $3,995 | Register |
| Nov 10–12, 2026 | PAT for Real-time Culture Monitoring and Closed-Loop Process Control | $2,975 | Register |
| TBD | Microbial Contamination Control in Bioprocessing Operations | $2,975 |
Register by June 8
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).
Delivery methods
30% Lecture
20% Discussion/group activity
50% Hands-on lab experience
Course content
20% Fundamentals and concepts
80% Industry applications
22.5 hours of instruction
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