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Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy

Register through our online system by clicking the link above.

Delivery methods

Course content

upstream course
Upstream
downstream course
Downstream
analytical course
Analytical

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 support personnel who may not be directly involved with the process they support
  • Vendors who supply the biomanufacturing industry with equipment and components

Attend and you will receive

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

Instructors

  • Laurie Overton
  • Gary Gilleskie, Ph.D.
  • Caroline Smith-Moore, Ph.D.
  • Cristiana Boi, Ph.D.: Dr. Cristiana Boi is an associate professor of chemical engineering at the University of Bologna, Italy, and adjunct assistant professor of chemical and biomolecular engineering at NC State University. Her research activity deals with difficult separations and focuses on the fundamental aspects of the different processes considered and on their possible applications. In recent years, her interest has shifted towards separations for bioprocessing and biomedical applications using membranes and chromatographic processes to purify biological molecules of therapeutic interest or to remove toxins and small molecules from blood and water streams. Since February 2017, she has been the president of the European Membrane Society (EMS).

Fee

$4,000

NIIMBL logo

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).

NCBC logo

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.

Payment

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 melody_woodyard@ncsu.edu to make arrangements immediately after registering and note the following:

  • If you wish to pay by PO, company check, or wire transfer, 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 2% processing fee to the total cost of the course for all PO, company check, or wire transfer payments.

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

Discounts available

A 20% discount is available 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.

Cancellation policies

Cancellation by registrant

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to melody_woodyard@ncsu.edu 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 melody_woodyard@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 melody_woodyard@ncsu.edu 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.