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Biopharmaceutical Assay Essentials

July 25–28, 2017
Part 1: July 25–26, 2017
Part 2: July 27–28, 2017

Register through our online system by selecting a link above.

Delivery methods

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bar graph of lecture delivery 30% Lecture
bar graph of discussion/activity delivery 20% Discussion/group activity
bar graph of hands-on lab experience delivery 50% Hands-on lab experience

Course content

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bar graph of fundamentals and concepts content 20% Fundamentals and concepts
bar graph of industry applications content 80% Industry applications
analytical course

Analytical

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

Why should you attend?

Attend this course to gain a fundamental understanding of successful bioanalytical assay development and validation. This course is composed of primarily hands-on activities with some lecture. You’ll get hands-on experience with designing and developing an ELISA. After assay optimization, the ELISA will be validated by considering ICH guideline Q2(R1). You’ll gain an appreciation for the complexities involved in biopharmaceutical analysis and learn about troubleshooting, data analysis, and experimental design. You’ll also gain a fundamental understanding of analytical technologies used in biomanufacturing QC/analytical laboratories and get hands-on experience with HPLC, MALDI-TOF mass spectrometry, spectroscopy, and gel electrophoresis. In addition, you’ll gain an appreciation for the various tools available for biopharmaceutical analysis.

Attend and you will learn

Part 1

  • In-depth operation of ELISA
  • How to design, develop, optimize and validate an ELISA
  • Common protein conjugation strategies
  • Critical sources of variability in ELISAs
  • Bioanalytical method development and validation

Part 2

  • Basic operation of HPLC, MALDI-TOF techniques
  • How to use peptide mass fingerprinting for protein characterization
  • Protein sizing techniques
  • Purity assessment
  • Basic assay design

Who should attend

  • Professionals new to the biopharmaceutical industry or entering new work assignments encompassing analytical or QC environments
  • Professionals with previous QC/analytical experience who want to learn new techniques and/or broaden their understanding

Attend and you will receive

  • 14 hours of instruction (1.4 Continuing Education Units)
  • Morning coffee
  • Lunch
  • Afternoon beverage break
  • Certificate of attendance

Instructor

Nathaniel Hentz, Ph.D.  

Fee

  • Full four-day course: $2,720
  • Part 1 only (two days): $1,360
  • Part 2 only (two days): $1,360

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 accepts payment from all major credit cards including American Express, Visa, and MasterCard. If you wish to pay by company check, please email melody_woodyard@ncsu.edu for additional information immediately after registering.

Discounts available

A 20% discount is available to:

A 30% discount is available to faculty/staff working in academic environments.

Check out BTEC’s professional development certificate program for an additional way to save money on short course costs.

Short course cancellations

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

Registered course participants will receive an email two weeks before the scheduled course with detailed information regarding travel to BTEC, parking information, and a short pre-course questionnaire.