Biopharmaceutical Assay Essentials

July 21–24, 2020 – Full Four-Day Course
July 21–22, 2020 – Part 1: Two Day Assay Development section
July 23–24, 2020 – Part 2: Two Day Biopharmaceutical Analysis section

Register through our online system by clicking the links above.

Delivery methods

Course content

analytical course


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

  • 15 hours of instruction for each part (per part: 1.5 Continuing Education Units, CEUs; for both parts, 3.0 CEUs)
  • Notebook containing all course lecture and lab materials
  • Morning coffee
  • Lunch
  • Afternoon beverage break
  • Certificate of attendance


Caroline Smith-Moore, Ph.D.
Brian Mosley


  • Full four-day course: $2,400
  • Part 1 only (two days): $1,600
  • Part 2 only (two days): $1,600


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.


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 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

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 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 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 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.