Content

AAV Quality Attributes: Theory and Practice

Register for this course by selecting a date above.

This course was formerly titled “Analytical Methods for Gene Therapy Vector Characterization and Testing.”

Delivery methods

Course content

analytical course

Analytical or Automation

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
  • Notebook containing all course lecture and lab materials
  • Morning coffee and tea
  • Lunch
  • Afternoon beverage break
  • Certificate of completion

Instructors

Fee

$2,975

Location

The Golden LEAF BTEC building is located at 850 Oval Drive on NC State University's Centennial Campus.

If a course is full: Waitlist policy

If a course you want to take is already full, you are welcome to email mswoodya@ncsu.edu and ask to be placed on a waitlist for that course. The waitlist is used to fill any seats that become available when individuals registered for the course are unable to attend. If one or more seats become available, individuals on the waitlist are contacted in the order in which they were added to the list.

In addition to ensuring popular courses remain full, waitlists provide a means of tracking interest and determining if additional sessions are necessary. BTEC makes every effort to schedule additional course offerings if sufficient people are wait-listed. If a new offering is scheduled, those on the waitlist are notified before registration opens to the public.

Placement on a waitlist does not commit individuals to attending a course. It simply ensures that they are given first opportunity to enroll if a seat becomes available in a full course and that they are among the first to know if an additional course offering is scheduled during the current year.

BTEC is unable to provide information about the number of those wait-listed for any given course or an individual's place on such a list.

Payment

BTEC requires payment by credit card at the time of registration. BTEC accepts payment from all major credit cards including American Express, Visa, and MasterCard.

After registration, a payment receipt is automatically emailed. If you do not receive the email, please check your spam folders.

Any additional questions prior to registration should be directed to mswoodya@ncsu.edu.

Discounts available

A 20% discount is available for NIIMBL members for the following courses:

Check out BTEC’s professional development certificate program for an additional way to save money on in-person course costs. Any additional discount questions prior to registration should be directed to Serena Hodge, Industry Training Coordinator, at shodge@ncsu.edu.

Cancellation policies

Cancellation by registrant

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by email to mswoodya@ncsu.edu. Fees are refunded according to the following schedule:

  • 100% refund – If notification is received at least 15 business days in advance of course start date
  • 75% refund – If notification is received 10–14 business days in advance of course start date
  • 50% refund – If notification is received 6–9 business days in advance of course start date
  • No refund will be issued if notice is received 5 or fewer business days in advance of course start

Refunds will take 60–90 days for processing. Refunds requested more than 90 days after payment will be issued as a check.

Substitutions may be made up to two business days prior to the course start date. Notify the BTEC office by emailing shodge@ncsu.edu. Please include the name and email contact for the replacement. Please note that BTEC is unable to honor substitutions for individuals taking discounted courses as part of the professional development certificate program.

Cancellation by BTEC

BTEC retains the right to cancel an in-person course no less than 10 business days in advance of the scheduled course start date. Registrants will be notified by BTEC if a course is cancelled and will receive a full refund of registration fees paid. BTEC is not responsible for airfare penalties or other costs incurred due to cancellation.

Pre-course communication

Upon successful registration for a course, you will receive an automatically-generated email as well as another email from Melody Woodyard confirming your registration. If you do not receive these emails within two business days of registering for a course, please email mswoodya@ncsu.edu to confirm your registration.

Once registered, confirmed course participants will receive a series of emails approximately two weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.