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Biopharmaceutical Lyophilization and Spray Drying

Register for this course by selecting the date above.

Delivery methods

Course content

Why should you attend?

In this three-and-a-half-day course, you will learn the principles of lyophilization (freeze drying) and spray drying. Specific concepts like heat and mass transfer, critical process parameters for cycle optimization, and the advantages/limitations of each technique will be presented. Lab activities — including hands-on material characterization, freeze and spray drying runs, as well as final product testing — will be used to demonstrate the concepts presented.

Lyophilization (freeze drying) and spray drying are used in biomanufacturing as methods to improve drug product stability and increase product shelf-life. For successful implementation of these techniques, it is critical to understand the process parameters that drive each step of the drying process. These parameters include the physical properties of materials as measured by differential scanning calorimetry (DSC) and freeze-drying microscopy, the fundamental theories of heat and mass transfer, and the operational limits of the equipment in terms of geometry and flow. In this course, participants will also be introduced to a range of product-specific topics including formulation considerations, target product profiles, and critical quality attributes. Finally, this course will cover product characterization by visual inspection, scanning electron microscopy (SEM), moisture content by headspace analysis and Karl Fisher (KF) titration, reconstitution time, particulate matter, and pH.

Attend and you will learn

  • How to develop basic lyophilization and spray drying cycles
  • To identify how changing cycle parameters affect the final dried product
  • To properly characterize materials using DSC and freeze-dry microscopy
  • To evaluate final product quality using multiple analytical techniques

Who should attend

This course is intended for process development scientists and engineers working in formulation and process development.  Other individuals who may benefit from this course include graduate students and faculty working in the areas of formulation development, drug product or protein stability, and biopharmaceutical drying.

Attend and you will receive

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

Instructor

Anthony Klos is a Principal Process Development Engineer at Grifols, based at the Clayton, NC facility. Anthony has over 30 years of experience with lyophilization, starting with Bayer HealthCare, where he characterized and developed lyo cycles, scaled lyo cycles up to manufacturing, and transferred lyo cycles to CMOs and other Bayer facilities.

After Bayer sold its Biologicals Division to Talecris Biotherapeutic in 2005, Anthony led the Formulation Development Group within Talecris R&D, including the lyophilization, the device development and the formulation groups. Anthony continued his duties when Grifols purchased Talecris in 2011.

He obtained Bachelor of Science degrees in mathematics and biology from the University of Oregon and a BchE, Chemical Engineering, from the University of Minnesota. He earned a Master of Science in chemical engineering from NC State University.

Fee

$3,995

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.

If a course is full: Waitlist policy

If a course you want to take is already full, you are welcome to email mswoodya@ncsu.edu 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.

Payment

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 mswoodya@ncsu.edu.

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 shodge@ncsu.edu.

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 mswoodya@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

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 mswoodya@ncsu.edu 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 mswoodya@ncsu.edu 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.