Fundamentals of Lyophilization for Life Sciences, Bioprocess and Pharmaceuticals

Glass Vials for Lyophylization

Fundamentals of Lyophilization for Life Sciences, Bioprocess and Pharmaceuticals

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Overview

The course is designed to familiarize students with the fundamentals of lyophilization (freeze-drying) and is applicable to life sciences, pharmaceuticals, food processing and general bioprocessing. The course focuses on the freeze-drying process itself (with emphasis on heat and mass transfer), formulation design, characterization, process development, product monitoring, and analysis of the freeze-dried product.

This is a 6-month course taught remotely by experts at Biopharma Group with live webinars and tutorials, and a 3-day, on-site lab practicum at UMass Lowell's lyophilization lab in Lowell, MA.

Self-study supported by educational materials provided. There will be case studies and workshops including identifying defects in products and how to solve such problems. Recordings of sessions will be available for playback and repeated viewing.

Audience

This course is designed for professionals in life sciences, pharmaceuticals, and bioprocessing who would like to expand and reinforce their technical knowledge in these sectors.

Learning Outcomes

At the end of this course, participants will have gained an in-depth knowledge of freeze-drying, equivalent to 5 years of working experience in the science of lyophilization including:
  • Understanding the science of how freeze-drying works
  • The physics and chemistry of freezing, sublimation, and desorption
  • Aspects of equipment design to effect heat and mass transfer
  • Control and monitoring of the process and lyophilizer
  • Gaining knowledge of the different approaches to developing a freeze-drying cycle for products with various requirements (Critical Quality Attributes)
  • Learning about the range of methods available for characterization of the final product
  • Program, load, operate and unload a freeze-dryer
  • Prepare a liquid formulation and pipette into containers in defined doses
  • Learning about aspects of formulation design and the value of characterization methods that can be applied prior to freeze drying
  • Operate analytical instruments and interpret data from:
    • Freeze Drying Microscope
    • Thermal and Impedance Analyzer
  • Recognizing physical defects in products by observation

Curriculum

- 21 sessions - Live online lectures and tutorials (approx. 2 hr each)
- 3 laboratory days — On-site practical laboratory sessions at UMass Lowell
- 5 assignments - including lab write-up

Live Online Lectures & Tutorials

  • Introduction to freeze-drying
  • Freezing and thermal treatment of aqueous solutions
  • Primary drying (sublimation)
  • Secondary drying (desorption)
  • Concepts of formulation for freeze-dried products
  • Formulation characterization methods part 1 — freeze drying microscopy
  • Formulation characterization methods part 2 — frozen state thermal analysis
  • Container-closure systems and their impact on the process and shelf stability
  • Freeze drying cycle development part 1 — classical iterative methodology
  • Freeze drying cycle development part 2 — software-based process design
  • Process monitoring and process analytical technology (PAT) in freeze drying
  • Scaling up from benchtop trials to full-scale production
  • Freeze-dried product analysis part 1 — residual moisture, container-closure integrity
  • Freeze-dried product analysis part 2 — dry state thermal analysis and stability
  • Freeze-dried product analysis part 3 — mechanical properties and rehydration

Practical Lab Sessions (3 days on campus at UMass Lowell)

The 3-day, on-site laboratory practicum will be taught at the UMass Lowell Lyophilization Lab. Participants are expected to attend this session. Information will be provided on travel and overnight accommodations.

  • Session 1: Hands on analysis of liquid samples with freeze drying microscopy/DSC/DTA/impedance — part 1 - analysis of simple dextran solution
  • Session 2: Hands on analysis of liquid samples with freeze drying microscopy/DSC/DTA/impedance — part 2 - analysis of a complex liquid formulation
  • Session 3: Start freeze drying cycle for dextran formulation
  • Session 4: Remove samples from freeze dryers; retrieve and review cycle data
  • Session 5: Visual inspection of dried products, analysis of freeze-dried product with KF, DSC, send samples for SEM, and MicroPress analysis
  • Session 6: Review cycle data with additional data from KF, DSC, SEM, MicroPress
  • Appearance and visual defects inspection for comparison to cycle traces and critical temperature for root cause determination of example freeze drying cycles

Supplementary Learning

  • Practical laboratory sessions will need to be written up in a formal report format, with methods described, and data presented and discussed.
  • Students will be set further learning activities including background reading and other assignments as part of the course.

Assessment of Completion

A Certificate of Completion will be issued from UMass Lowell to students who register for and complete the course, based on successful demonstration of learning and competency.

Dates/Times

Wednesdays, beginning November 13, 2024*
  • 11:00 AM - 1:00 PM, EST
  • 8:00 AM — 10:00 AM, PST
*a detailed schedule will be provided to students upon registration. Some dates may change to accommodate holidays.

Cost

Early Registration

(Register and Pay by August 30, 2024):

  • Individual Rate: $6,250
  • Groups of 3+: $6,000 per person

Standard Registration

(After August 30, 2024):

  • Individual Rate: $6,750
  • Groups of 3+: $6,500 per person

About the Instructors

  • Biopharma Group's Director of R&D is globally recognised as a lyophilisation expert. Kevin has been in the field since 1993 and joined Biopharma Group in 2000. He's been involved numerous academic research projects and, together with his team, has worked on over 4,000 projects for customers worldwide. 

    Kevin received his PhD for investigations into the freeze-drying of pharmaceutical formulations and drug/vaccine delivery systems. Prior to joining the team, Kevin worked at Pfizer Central Research and as a Research Fellow in vaccine development at Aston University. 

    Dr. Ward is an editor and a contributing author of articles and texts on freeze drying, most recent being the Springer book 'Lyophilization of Pharmaceuticals and Biologicals'. He is also in demand as a frequent lecturer to many of the leading regulatory agencies and prominent pharma companies

    More About Dr. Kevin Ward »

  • Edmond is the Research & Development Manager at Biopharma. With over a decade of experience in the pharmaceutical industry spanning roles as a Pharmacist, Principal Scientist, and now an R&D manager. Edmond joined the team in 2014 after a PhD from Aston University in Birmingham, UK. His PhD focused on optimising the bulk freeze-drying process and the implications of powder rheology using methods including the novel use of Micro X-ray tomography. He also holds an MSc in Pharmaceutical Science with Management Studies (Distinction) from Kingston University in London. Edmond brings a unique perspective to drug development, leading a team of talented scientists and brings a wealth of expertise in stabilising parenteral, biologics, small molecules and in vitro diagnostics using rigorous research and development. Edmond's expertise in lyophilisation has proven invaluable to numerous small to large biotech and pharmaceutical companies over the years through consultancy. Beyond the lab coat and boardroom, Edmond has a passion for football and enjoys crafting delectable dishes in the kitchen.

    More About Dr. Edmond Ekenlebie »

  • Mervyn holds a BSc (hons) Biochemistry Degree from the University of Portsmouth. After graduating in July 2009, Mervyn joined Biopharma in December 2009, where he worked for six years to 2015. During this time, Mervyn gained significant experience of product analysis and freeze-drying cycle development/optimisation. Following this, Mervyn joined the Bio Products Laboratory (BPL), where he worked within a production setting, gaining considerable experience of the operations of production freeze-dryers and the management of GMP cleanroom environments. During his time at BPL, Mervyn also attained a master's degree in Biopharmaceuticals from King's College London, having conducted a research project within the R&D department at BPL which focused on the impact of viricidal heat treatment processes on Factor VIII/ vWF concentrates.

    Mervyn returned to Biopharma Group as a Senior Scientist in February 2021 and has since worked on approximately 50 customer projects involving a range of activities, including characterisation of both pre-lyophilised and lyophilised products, formulation development, freeze-drying cycle development and optimisation, process auditing and consultancy on all stages of the freeze-drying development and scale-up process. Additionally, Mervyn is a contributor to the freeze-drying courses provided by Biopharma, during which he delivers lectures and provides hands-on training with the freeze-drying equipment and analytical instruments associated with product characterisation.

    Mervyn lives by the seaside with his wife, three young children and three small dogs. Together they love doing lots of seaside related activities, including walks along the beach, kayaking and paddleboarding.

    More About Mervyn Middleton »

  • Bhaskar joined Biopharma Group in 2021 as a Senior Scientist after a PhD from De Montfort University in Leicester, UK. Working with Professor Geoff Smith, his PhD was centred on the single vial monitoring of the freeze drying process using through vial impedance spectroscopy (TVIS). At Biopharma Process Systems in Winchester, Bhaskar is managing several highly collaborative projects for clients in the pharma and diagnostics sectors involving product and process assessments, formulation development, lyophilization cycle development, post process analyses, packaging and consultancy for new and existing products.

    Bhaskar holds a BSc (Hons) in Pharmaceutical and Cosmetic Science with a sandwich industrial placement within product development of Zydis® ODT at Catalent in Swindon, UK. He also holds a master's by Research (MRes) from University College London, where his research involved exploring the paediatric application of hot melt extrusion and cyclodextrins for reformulating a poorly soluble active ingredient.

    Bhaskar has been playing the 'Tabla', an Indian percussionist instrument since childhood and loves to jam! He is also a Cricket enthusiast and dreams to play in the World Cup after retiring!

    More About Dr. Bhaskar Pandya »

  • Biopharma Group was established in 1989 and has become an industry leader with expertise in freeze drying equipment and scientific techniques.

    The technical lyophilization division assists companies internationally to improve their freeze-drying processes and practices across the disciplines as a CRO, and CDMO, analytical instruments and training.

    Our scientific team has been involved with many University research projects since our inception, keeping Biopharma Group at the forefront of the field of lyophilization. With this course offering, we have collaborated with UML to provide a unique opportunity to learn and develop skills in this specialist field.

    Dr Kevin Ward, Biopharma Group's Director of Research and Development, has recently edited and published a textbook on lyophilization. As experts in freeze-drying, we support the pharma /biotech and diagnostic industries to develop their knowledge of the lyophilization process. Our consultancy/contract research team provides independent R&D services from proof of concept to scale-up and everything in between, as well as GMP manufacturing and packing lines that can be offered as additional services. We have developed several pieces of analytical equipment for the analysis of freeze-dried products, the resulting data can be applied to produce a robust formulation and lyo cycle for users. These instruments are sold to our customers globally.

    Our courses are well respected throughout the industry, and we have trained over 6,000 people worldwide. This course is the only one of its type available in the US.

    We welcome you to investigate what Biopharma Group can do for you. https://biopharmagroup.org/

  • The Core Research Facilities (CRF) at UMass Lowell comprises 11 laboratories housing more than 125 high-end instruments and testing facilities supporting research in materials testing, surface and forensic analysis, nanofabrication/nanotechnology, next generation sequencing (NGS), materials characterization, mass spectroscopy, chromatography, microscopy, radiation testing, and robotics. Instruments and professional level services are available to outside users. Learn more about UML CRF here: www.uml.edu/research/crf
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