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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?

Gain a deep understanding of the unique quality attributes that define these complex drug products. Enhance your expertise and engage with industry professionals. Join us to elevate your career in gene therapy!

Why learn about quality attributes for these products?

Controlling the critical quality attributes (CQAs) of a drug product is critical to biomanufacturing. Viral-vector based gene therapy products, like the popular adeno-associated virus (AAV), are more chemically and physically complex than traditional biopharmaceuticals due to their larger size and combination of protein capsid and nucleic acid payload. As a result, defining and measuring quality attributes of viral vectors has required the use of new and innovative analytical methods.

Attend and you will learn

Attend this course to experience 3 days of interactive lectures, hands-on labs, and group workshops related to determining the critical quality attributes of gene therapies, using AAV as a model.

Industry-relevant classroom content:

  • The history, basic biology, and manufacturing processes for gene therapies, focusing on viral-vector based products
  • Current industry and regulatory expectations for CQAs, including emerging trends
  • The current landscape of analytical tests used to assess CQAs for AAV
  • Theory and practical application of analytical ultracentrifugation (AUC) for determining AAV purity
  • Special sessions on measuring empty vs full capsids and reviewing initial marketing authorization documents (EMA EPARS)

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
  • Next-generation sequencing workshop
  • Cell-based infectivity lab

Who should attend

This course will benefit professionals looking for a better understanding of the gene therapy quality attributes regulatory landscape and its associated analytical methods to enhance your career.

We welcome those who are:

  • New to the field or transitioning to tackle gene therapy
  • In gene therapy and looking to expand their knowledge

Examples of past participants’ career paths:

  • Managers and directors wishing to broaden their expertise
  • Quality assurance professionals interested in science and theory
  • Sales professionals looking to understand their products better
  • Developments scientists seeking insights on supporting analytic methods and quality expectations
  • Biomanufacturing professionals interested in better understanding their modality

Examples of past participants' companies:

  • Large and small biopharmaceutical
  • Contract research (CROs) and contract development and manufacturing (CDMOs)
  • Biopharmaceutical vendors, suppliers, and distributors
  • Regulatory professionals
  • Trainers and consultants in biopharmaceuticals

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

All courses are offered on site at BTEC, other than online courses. 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 short 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 email to mswoodya@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 a professional development short 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.