AAV Quality Attributes: Theory and Practice
Take this course to experience a 3-day, hands-on, overview of AAV Quality Attributes. Step through each CQA category, Identity, Quantity, Potency, Purity and Safety through interactive lectures, group workshops, and hands-on labs in BTEC’s state of the art facility. All course content is directly related to current applications in industry while providing basic theory to explain the underlying science.
Attendees will take a 3-day journey through the AAV Quality Attributes and CQAs. For each quality attribute, you will learn:
- Specific characteristics to evaluate
- Commonly utilized and cutting-edge techniques
- Regulatory expectations and industry trends
Participants will take a deeper dive into some of the key analytical techniques with hands-on labs and workshops:
- ddPCR lab and workshop
- Transmission Electron Microscopy (TEM) lab
- Capillary Gel Electrophoresis (CGE) lab and workshop
- High-performance Liquid Chromatography: Size Exclusion column with Multi-Angle Light Scattering (HPLC-SE / MALS) lab and workshop
- Analytical Ultracentrifugation (AUC) session
- Next Generation Sequencing workshop
| 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 |
| November 12-19 | Microbial Contamination Control in Bioprocessing Operations | $2,975 |
Register by June 29
Attend and you will learn
- What differentiates gene therapy viral vector Quality Attributes and why — history, basic biology, and manufacturing processes
- Current industry and regulatory expectations, including future trends
- What is being characterized and/or measured for each Quality and Critical Quality Attribute category, how and why
- The current landscape of analytical tests used in AAV development and manufacturing
- How and why key AAV assays are performed with hands-on experience in BTEC’s biomanufacturing training labs: ddPCR
- Special sessions on measuring Empty vs Full Capsids, Analytical Ultracentrifugation (AUC) and EMA EPARs (initial marketing authorization documents)
Delivery methods
50% Lecture
20% Discussion/group activity
30% Hands-on lab experience
Course content
30% Fundamentals and concepts
50% Industry applications
20% Emerging technologies
24 hours of instruction
Who should attend
- The course will benefit those new to gene therapy or looking to expand their knowledge. Our list of satisfied participants includes those from biopharmaceutical companies, contract research (CROs), contract development and manufacturing organizations (CDMOs), pharmaceutical vendors, suppliers, and distributors, equipment sales, and trainers in the biopharmaceutical discipline. You will leave the course with a better understanding of the gene therapy regulatory landscape and its associated analytical methods that will enhance your career at any stage.
- We welcome those who are:
- New to the field or transitioning to tackle gene therapy
- Individuals interested in cross-training
- Managers and directors wishing to broaden their expertise
- Quality assurance professionals interested in science and theory
- Sales professionals looking to understand their products better
Custom offerings for groups of 4 or more are available on request. Contact BTEC for more information.