Biopharmaceutical Particle Characterization
|60% Hands-on lab experience|
|30% Fundamentals and concepts|
|60% Industry applications|
|10% Emerging technologies|
This course can count toward your Professional Certificate in Biomanufacturing Science.
Why should you attend?
Biologic product development and quality control presents significant challenges in sub-micron particle characterization. Even in the absence of exogenous particulates, the labile nature of biologic therapeutics makes them susceptible to unfolding, aggregation and ultimately particulate formation. The particle sizes present span a size range from a few nm to tens of µm leading to particularly difficult particle size distribution characterization problems. Proper analysis requires the concurrent use of several particle-sizing technologies each of which is well suited for interrogating a given portion of the particle size distribution.Offered in partnership with Malvern Instruments, this 3.5 day workshop focuses on the proper selection and implementation of analytical technologies within the area of sub-micron particle counting in biotherapeutic formulations. The course includes a combination of lecture and hands-on laboratory work utilizing typical mAb based biotherapeutic samples.
Attend and you will learn
- Why sub-micron particles are of interest to FDA
- Why protein biotherapeutics are susceptible to aggregation
- How to select a particle sizing technology based on a given particle size range
- Operational principles underlying particle sizing methods such as dynamic light scattering, size exclusion chromatography, digital imaging methods, nanoparticle tracking and resonant mass measurements
Who should attend
The course covers material that is relevant to anyone in the biopharmaceutical manufacturing industry who require an understanding of the challenges associated with sub-micron particle characterization:
- Scientists and engineers (MS, PhD, or equivalent experience) working in biopharmaceutical research, development, process development, and QC/analytical laboratories
- Formulation scientists
- Technical managers
Attend and you will receive
- 30 hours of instruction
- Morning coffee
- Afternoon beverage break
- Certificate of attendance
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 email@example.com 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 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 firstname.lastname@example.org to make arrangements immediately after registering and note the following:
- If you wish to pay by PO or company check, 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 $75 processing fee to the total cost of the course for all PO or company check payments.
Any additional questions prior to registration should be directed to email@example.com.
A 20% discount is available for select courses 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. Any additional discount questions prior to registration should be directed to firstname.lastname@example.org.
Cancellation by registrant
To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to email@example.com 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 firstname.lastname@example.org. 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.
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 email@example.com 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.