Content

AAV Quality Attributes: Theory and Practice

Delivery methods

Course content

analytical course

Special Topics

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

Why should you attend?

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

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)

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.

 

Attend and you will receive

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

Instructors

Fee

$2,975

Important Information for In-person Course Participants

Please read about BTEC’s policies on payment, cancellation, pre-course communication and other important information for in-person courses offered on site at BTEC.