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Introduction to Biopharmaceutical Lyophilization

Lyophilization (freeze drying) is used in biomanufacturing processes to remove solvent from drug products and improve stability. In this two-day hands-on course, you will learn the principles of biopharmaceutical lyophilization, process development, and dried product analysis.

In lectures and hands-on lab sessions, you will learn basic drying principles about how process inputs such as cycle temperature, time, formulation, and other factors influence final product quality attributes. Gain experience in the operation of laboratory scale lyophilization (SP VirTis Genesis) equipment. Using differential scanning calorimetry (DSC) and freeze dry microscopy (FDM), you will learn to determine critical product temperatures such as glass transition and collapse temperature which are key to designing a successful drying cycle. Moisture content and water activity of lyophilized products will be measured with Karl Fischer titration and tunable diode laser absorption spectroscopy (TDLAS) headspace analysis. Additional analytical techniques covered include visual inspection, reconstitution, and particulate analysis.

This course can be paired with Essentials of Spray Drying and Powder Analysis for a complimentary overview of additional drying techniques.

DatesCourseCostRegistration
May 12-13, 2026Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation$1,500Register
May 20–21, 2026Hands-On Essentials of Automation for Biomanufacturing$2,050Register
May 27–29, 2026Preparative Chromatography Column Packing: Lab to Process Scale$2,500Register
June 3–4, 2026Applied Cleaning Validation Practices: A STERIS Master Class$2,000Register
June 9–10, 2026Introduction to Biopharmaceutical Lyophilization$1,975Register
June 11, 2026Essentials of Spray Drying and Powder Analysis$995Register
June 16–18, 2026Fundamentals of Mammalian Cell Line Development$3,100Register
June 23–25, 2026Biopharmaceutical Assay Essentials$3,100Register
June 23–25, 2026Fermentation Engineering$3,100Register
June 30–July 2, 2026Hands-On Principles of mRNA Technology$2,500Register
July 8–10, 2026Downstream Biopharmaceutical Processes: Fundamentals and Design$3,100Register
July 14–16, 2026AAV Quality Attributes: Theory and Practice$2,975Register
July 14–17, 2026Hands-On cGMP Biomanufacturing Operations$4,200Register
July 28–31, 2026Hands-On Biomanufacturing of Vectors for Gene Therapy$4,500Register
Aug 6, 2026Design of Experiments for Biomanufacturing$500*Register
Sept 29–Oct 1, 2026Cell Culture Engineering$4,200Register
Oct 13–16, 2026Applied Principles and Techniques of Depth Flow Filtration (DFF) and Tangential Flow Filtration (TFF) for BioPharm Purification$3,995Register
Nov 10–12, 2026PAT for Real-time Culture Monitoring and Closed-Loop Process Control$2,975Register
November 12-19Microbial Contamination Control in Bioprocessing Operations$2,975

Register by May 25

Attend and you will learn 

  • Basic principles of lyophilization
  • To identify how drying process parameters affect the final dried product
  • To properly characterize critical material temperatures using differential scanning calorimetry and freeze-dry microscopy
  • To evaluate final product quality using multiple analytical techniques

Delivery methods

40% Lecture
60% Hands-on lab experience

Course content

14 hours of instruction

Who should attend

Anyone new to biopharmaceutical drying technologies and dried product quality analysis or with interest in advancing their understanding of the topic. This course is suitable for a wide audience including those in manufacturing, process development, research, sales, marketing, or managerial roles.

Professional certificate

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

Instructors

Important Information for Course Participants

Please read about BTEC’s policies on payment, cancellation, pre-course communication and other important information for in-person courses offered on site at BTEC.