Analytical Methods for Gene Therapy Vector Characterization and Testing
Register for this course by selecting the date above.
|20% Discussion/group activity|
|50% Hands-on lab experience|
|30% Fundamentals and concepts|
|50% Industry applications|
|20% Emerging technologies|
This course can count toward your Professional Certificate in Biomanufacturing Science.
Why should you attend?
In this four day, hands-on course, professionals with some experience in analytical testing or development will gain both theoretical knowledge and hands-on practice analyzing adeno-associated viral vectors. Participants will learn the basics of how adeno-associated viruses (AAVs) are produced and the analytical challenges that some of these production schemes introduce. Those attending will gain familiarity with methods used for evaluating the quantity, purity, potency, and safety of these products.
They will also gain hands-on experience with equipment and assays currently used in AAV characterization and analysis, including Droplet Digital PCR, capillary electrophoresis, HPLC, MALS, and cell-based assays. The hands-on lab experiments will be grounded in foundational analytical concepts of validation and assay design. An analysis of the data derived from these experiments will also be used in discussion-oriented workshop sessions. Lecture material will focus on the foundational knowledge of how and why the analytical techniques work for these molecules, which will provide participants with a deeper understanding and enhance their troubleshooting skills.
Attend and you will learn
- To identify analytic tests and methods for gene therapy vector process intermediates, drug substance, and drug product
- To describe underlying principles of analytical methods used to measure vector quantity, purity, and potency
- To describe methods used to characterize vectors as part of product/process development
- To execute and troubleshoot assays taught in the course, given an appropriate procedure
- To describe basic assay validation concepts and apply those concepts to the validation of analytical methods presented
Who should attend
This course is intended for analytical development scientists, QC analysts, and others working in the analytical lab involved in AAV analysis or interested in learning about it. Those involved in process development would also benefit in learning available analytical techniques for these vectors and the associated challenges. Others who may benefit include vendors with an analytical background, as well as graduate students or postdocs involved in gene therapy.
Attend and you will receive
- 27 hours of instruction
- Notebook containing all course lecture and lab materials
- Morning coffee
- Afternoon beverage break
- Certificate of attendance
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 firstname.lastname@example.org 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.
BTEC strongly prefers payment by credit card at the time of registration. BTEC accepts payment from all major credit cards including American Express, Visa, and MasterCard. If you are not paying by credit card at the time of registration, please email email@example.com to make arrangements immediately after registering and note the following:
- If you wish to pay by PO or company check, please note that payment is due within 10 days of registration. If paying by PO, please reference PO number in your email, but note that a PO number will not hold a seat.
- If no payment has been received within 10 business days of registration, BTEC reserves the right to cancel registration based on enrollment demand.
- BTEC will add a $75 processing fee to the total cost of the course for all PO or company check payments.
Any additional questions prior to registration should be directed to firstname.lastname@example.org.
A 20% discount is available for select courses to:
- Employees of BMF companies
- Groups of five or more from one company registering for the same offering of this course
- Individuals registering for more than one course at a time
- Faculty/staff working in academic environments
A 40% discount is available for NIIMBL members for the following courses:
- Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy
- Hands-on Essentials of Automation for Biomanufacturing
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 email@example.com.
Cancellation by registrant
To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to firstname.lastname@example.org or fax to 919-513-1697. 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
Substitutions may be made up to two business days prior to the course start date. Notify the BTEC office by fax at 919-513-1697 or by e-mail to email@example.com. 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.
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 firstname.lastname@example.org to confirm your registration.
Once registered, confirmed course participants will receive an email approximately three weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.