Biopharmaceutical Assay Essentials

Register for this course by selecting the date 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 assays, then validating them 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 spectroscopy, electrophoresis (gel and capillary), U/HPLC, MALDI-TOF mass spectrometry, and ESI liquid chromatography-mass spectrometry. In addition, you’ll gain an appreciation for the various tools available for biopharmaceutical analysis.

Attend and you will learn

  • Fundamentals of common bioanalytical techniques. Understand the principles and applications of major bioanalytical techniques, including plate-based assays, electrophoresis, analytical chromatography, and mass spectrometry.
  • How to perform specific practical assays. Learn how to perform specific assays such as ELISAs, protein sizing, peptide mapping, purity assessment, as well as basic operations of common analytical equipment, such as CE, U/HPLC and MS.
  • Bioanalytical method development and validation principles. Grasp the essentials of method validation, including designing experimental plans and understanding parameters like specificity, linearity, precision, accuracy, and limit of detection (LOD).

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

  • 22.5 hours of instruction
  • Notebook containing all course lecture and lab materials
  • Morning coffee and tea
  • Lunch
  • Afternoon beverage break
  • Certificate of completion



  • $2,975


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 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 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

Discounts available

A 40% 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

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 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

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 or by fax at 919-513-1697. 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 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.