Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy

Delivery methods

35% Lecture

10% Discussion/group activity

55% Hands-on lab experience

Course content

20% Fundamentals and concepts

70% Industry applications

10% Emerging technologies

Upstream

Downstream

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

Why should you attend?

To obtain hands-on training in the production of vectors for gene therapy products using an AAV2-GFP model system in both HEK293 cells and Sf9/Baculovirus systems. Engage in pilot/manufacturing-scale upstream operations (adherent and suspension cell culture, vector production scale-up in cell stacks and single-use bioreactors); downstream operations (cell lysis, product recovery via depth filtration, purification using chromatography, and ultrafiltration for concentration and buffer exchange); and analytical technologies, as well as discuss strategies and issues around scale-up, tech transfer, and adherent vs. suspension cultures.

Attend and you will be able to

List key cGMP (current Good Manufacturing Practice) requirements/expectations
Describe the unit operations commonly used for production of gene therapy vectors, including their purpose, underlying principles, and operation
Culture adherent and suspension cell lines
Optimize transient transfection conditions
Harvest vector using scalable operations and describe options for harvest process design
Purify vector using appropriate resins and AKTA chromatography systems
Formulate drug substance by ultrafiltration
Perform basic scale-up calculations for operations involved
List parameters that are monitored and/or controlled to ensure acceptable process performance
Calculate step yields for downstream operations
Describe analytical tools used in assessing and characterizing gene therapy products and processes

Who should attend

Anyone interested in obtaining basic knowledge and hands-on exposure to production-scale biomanufacturing operations used in the manufacturing of vectors for gene therapy products, such as the following:

New or existing biomanufacturing employees taking on a new assignment focused on gene therapy
Research scientists from academia or industry interested in gaining knowledge of cGMP manufacturing of AAV vectors
Biomanufacturing personnel who may not be directly involved with the process they support, including Validation, QA, or QC staff
Suppliers of components and contractors providing services to companies manufacturing viral vectors

Attend and you will receive

30 hours of instruction (3.0 Continuing Education Units)
Notebook containing all course lecture and lab materials
Morning coffee and tea
Lunch
Afternoon beverage break
Certificate of completion

Instructors

Fee

$4,295

This course was developed with a project award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB17H002).

Additional support has been provided by the North Carolina Biotechnology Center.

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.