"Recommended Best Practices for Lyophilization Validation – 2021 Part II: Process Qualification and Continued Process Verification” was accepted for publication by AAPS PharmSciTech on 7/31/21 and is now available as direct link at https://link.springer.com/content/pdf/10.1208/s12249-021-02107-6.pdf
The First Ever ASTMIntl consensus standard for lyophilization, E3250 - 21 Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying has just been issued and is currently available for your use. Thank you to Arnab Ganguly to leading this process and to the many LyoHUB contributors who contributed through their work on LyoHUB’s Recommended Best Practices for Process Monitoring Instrumentation in Pharmaceutical Freeze Drying Steve Nail, Serguei Tchessalov, Evgenyi Shalaev, Ernesto Renzi, Frank Dimarco, Lindsay Wegiel, Steven Ferris, William Kessler, Michael Pikal, Greg Sacha, Alina Alexeenko, T.N. Thompson, Cindy Reiter, James Searles and Paul Coiteux To read the full story click HERE
LyoHUB Publishes "Recommended Best Practices for Lyophilization Validation – 2021, Part II: Process Qualification and Continued Process Verification”. Link coming soon
LyoHUB publishes "Recommended Best Practices for Lyophilization Validation – 2021 Part I: Process Design and Modeling". Click here to go directly to the paper https://link.springer.com/article/10.1208/s12249-021-02086-8
Welcome new member, Jazz Pharmaceuticals
LyoHUB leads way in first accepted ASTM consensus standard for freeze drying, E3250-21Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying. This standard should be posted in entirety on the ASTM website at ASTM E3250 - 21 Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying
Welcome to new member, Elanco
Welcome to new member, FujiFilm!
Virtual Annual Meeting will be held on April 30. Call information available in members-only area of this site.
Welcome to new member, Sanofi!
LyoHUB Annual Meeting for Members only will be held on Friday, April 30, 2021 virtually.
LyoHUB Co-Director, Dr. Elizabeth Topp leads effort to develop a new drug form may help treat osteoporosis, calcium-related disorders
Purdue University innovators developed a stabilized form of human calcitonin, which is a peptide drug already used for people with osteoporosis. Researchers at Purdue created a prodrug form of the peptide hormone to increase its effectiveness as an osteoporosis treatment. To read the full article, visit New drug form may help treat osteoporosis, calcium-related disorders - Purdue University News
Happy Holidays from LyoHUB
LyoHUB now has a You Tube Channel. Subscribe to see all of our latest videos
LyoHUB's Andrew Strongrich, PhD Candidate at Purdue University will present "Next-Generation Process Monitoring in Lyophilization – Applications for Wireless Sensor Technology," on Thursday, November 19 at 10am and 2pm (EST). Click here to reserve your spot for this free webinar, visit: https://spscientific.com/Webinars/
Welcome to LyoHUB's newest member, SANOFI! We are glad to have you on board!
LyoHUB offers a FREE, OPEN SOURCE, SELF-PACED Online Lyophilization 101 Short Course. Start today by visiting https://pharmahub.org/courses/lyo101
This 8-module course will introduce participants to Lyophilization. This course also includes a lab exercise. A self-assessment is available after each module.
Module 1: Introduction to Pharmaceutical Lyophilization, Presented by Dr. Elizabeth Topp, Purdue University
In this video, students will learn what lyophilization is and its importance for the pharmaceutical industry. The major parts of a lyophilizer are named and a scientific basis for lyophilization is provided, as well as the lyophilization cycle phases.
Module 2: Overview of the Lyophilization Process, Presented by Dr. Arnab Ganguly, IMA Life
In this video, students will be introduced to freezing, primary drying and secondary drying and receive an overview of unit operations in production lyophilization.
Module 3: Production Lyophilizers, Presented by Dr. Alina Alexeenko, Purdue University
In this video, students will learn about the components of production lyophilizers including the chamber, tunnel, condenser, vacuum pump and refrigeration system. There is an introduction to sensors used to monitor temperature and pressure and current best practices.
Module 4: Glass Transition Temperature (Tg, Tg1), Presented by Dr. Akhilesh Bhambani, Merck and Co.
In this video, students will hear definitions of Tg and Tg’ and discover how Tg is measured using differential scanning calorimetry (DSC). Other topics include measurement of collapse temperature, estimation of Tg of mixtures, use of Tg and Tg’ in lyophilization cycle design and Tg and product stability.
Module 5: Freezing, Presented by Dr. Greg Sacha, Baxter
In this video, the thermodynamics of freezing and DSC thermograms, freeze concentration, eutectic mixtures, “skin” formation, freeze concentration and stability, controlled nucleation are discussed.
Module 6: Primary and Secondary Drying, Presented by Dr. Ehab Moussa, AbbVie
In this video, students are introduced to heat transfer (conduction, convection, radiation), mass transfer, vial heat transfer coefficient (Kv), measuring Kv, cake resistance (Rp), measuring Rp and spatial variation in drying of vials.
Module 7: Graphical Design Space, Presented by Dr. Steve Nail, Baxter
In this video, students will learn what sublimation rate vs. chamber pressure is and about the equipment capability curve, choked flow and choke point, shelf temperature and product temperature isotherms, Tg’ and collapse line, TDLAS and safe operating zone for lyophilization cycles.
Module 8: Quality Attributes of Lyophilized Products, Presented by Dr. Akhilesh Bhambani, Merck and Co.
In this video, students will learn about cake and vial appearance (collapse, partial collapse, shrinkage, cracking, fogging, lifting), rejectable vs. acceptable cosmetic defects, activity, sterility, reconstitution time, moisture content and stability and automated visual inspection.
VIRTUAL LAB EXERCISE IN PHARMACEUTICAL LYOPHILIZATION, Presented by Dr. Alina Alexeenko and Andrew Strongrich, Purdue University
In this video, students will learn learn how to develop and run a typical lyophilization cycle. This video was recorded in the LyoHUB Lyophilization Demonstration Facility at Purdue University.
Great article updating the public on what is new at LyoHUB https://www.purdue.edu/newsroom/purduetoday/releases/2020/Q2/lyohub-adds-new-course-in-freeze-drying-to-resources-that-can-assist-covid-19-research-in-diagnostics,-therapeutics-and-vaccines.html
Learn about the Importance of Lyophilization for Cancer Therapy for LyoHUB Co-Director, Elizabeth Topp HERE
Analytical Approach to Health Care Delivery course: Purdue University is offering a new series of three online engineering courses to students aspiring to a career in the health care industry and people currently employed in the field. https://www.purdue.edu/newsroom/releases/2020/Q2/purdue-offers-new-series-of-online-courses-in-health-care-technology.html
LyoHUB's Annual Report for 2020 is now available to download online. Click here to download.
LyoHUB is pleased to welcome its newest member, Corning!
LyoHUB's Annual Member Meeting will NOT be held in Chicago. It will be conducted in a series of Webex calls. Please contact Jen Gray to get an invitation to participate in the calls.
LyoHUB's Annual Member Meeting will be held on April 8, 2020 at the Big Ten Conference Center in Chicago and along with year in review and new business, will feature Industry 4.0 for Lyophilization: AI, Robotics, Sensors and Modeling to advance lyophilization technology. Contact Jen Gray to register.
LyoHUB is proud to welcome its newest member, Cook Biotech!
Happy Holidays from LyoHUB!
Excellent LyoHUB meeting at NIST! Thank you to all of the speakers, panelists and participants!
•Use of Modeling and Simulation in Drug/Device Development and Regulatory Evaluation including Post-Approval Changes by Tina Morrison, Deputy Director, Division of Applied Mechanics, CDRH, FDA
•Analytical Technologies for Product Quality Measurements by John Schiel, Institute for Bioscience and Biotechnology Research, NIST
•Drug Substance Manufacturing by Scott Lute, Center for Drug Evaluation and Research, Office of Biotechnology Products, FDA
•Regulatory Review Perspective on Lyophilization by Steve Rhieu, U.S. Public Health Service Commissioned Corps Officer, CDER, FDA
NSF grant could help enable 'self driving' pharmaceutical lyophilizers.
A $750,000 National Science Foundation grant aims to develop real-time sensor technologies, computational modeling and bioanalytical tools for closed-loop lyophilization. Millrock provided the machine researchers are using for the NSF project at LyoHub in Purdue’s Discovery Park. Read the full article here.
Registration now open for LyoHUB's Lyo Summer School: Lyo201:
#Characterization of #Lyophilized Solids July 10 & 11 at Purdue featuring training on #ssHDX-MS, Solid State #NMR, Lyo PRONTO, and more. Register by July 1, 2019 at http://conf.purdue.edu/lyosummer
April 10, 2019
LyoHUB celebrates its 5th Anniversary at its Annual Meeting in Chicago!
March 13, 2019
NOW AVAILABLE! Fundamentals of Freeze Drying presented by Steve Nail, Senior Research Scientist, Baxter Biopharma - (5) modules covering Process Overview, Freezing Process, Primary & Secondary Drying, Process Monitoring and Formulation Considerations https://pharmahub.org/resources/773
February 20, 2019
Changing Perceptions: An Understanding of #lyophilization Advancements - interesting article in Pharmaceutical Technology with quotes from Elizabeth Topp at Purdue Industrial and Physical Pharmacy, Alina Alexeenko PurdueAeroAstro, TN Thompson at Millrock Technologies and Sajal Patel at MedImmune http://www.pharmtech.com/changing-perceptions-understanding-lyophilization-advancements
January 29, 2019
Hope that you will join us at the upcoming Gordon Conference being held in New Hampshire from June 9-14, 2019. Liz Topp of LyoHUB and Karthik Nagapudi of Genentech are the conference chairs. The 2019 GRC will highlight: (i) advances in characterization tools that enable molecular understanding of formulations, (ii) new methodologies to enable intracellular delivery of large molecules and cell and gene-based therapies, (iii) novel manufacturing techniques, and (iv) modeling and simulation approaches that aid in designing formulations.
For more information and to register, please visit
January 20, 2019
LyoHUB is delighted to welcome its 19th member, Greene Tweed, a manufacturer of high-performance elastomers. To learn more about Greene Tweed, click on the logo below
We are pleased to announce the keynote speaker for the 2018 LyoHUB/ASTM Workshop on Pharmaceutical Manufacturing Research and Lyophilization, Joan Byrne, Vice President Science and Technology - Biologics and Combination Products at AbbVie. Ms. Byrne talk is "The Lyophilization Learning Curve - A Biopharmaceutical Perspective". Hope you can join us! Registration deadline is 10/10/18 at www.astm.org/E55WorkshopOct2018
High Performance Water Recycling system for Space Exploration uses freeze dry (lyophilization) process for transport and reactivation of bacteria. LyoHUB worked with Pancopia on this lyophilization process. Read the full story at https://sbir.nasa.gov/success-stories/high-performance-water-recycling-system-space-exploration
Registration is now open for the ASTM E66 meeting and LyoHUB Workshop on Pharmaceutical Lyophilization to be held on October 23, 2018 at Purdue University, West Lafayette, Indiana. Click HERE to register or visit
LyoHUB will be hosting the ASTM E55 (https://www.astm.org/COMMITTEE/E55.htm) workshop on Pharmaceutical Lyophilization on Tuesday, October 23, 2018 at Purdue University.
Congratulations Dr. Elizabeth Topp, recipient of the 2018 Chaney Faculty Scholar award. This award is the highest research award given to faculty by the Purdue College of Pharmacy. The award recognizes outstanding research, scholarship or creative activity including professional accomplishments in the recipient's field. To learn more about Dr. Topp's research, please visit https://www.ipph.purdue.edu/faculty/topp
Welcome to our newest member, Abbott! Click on the logo below for more information about Abbott!
February 22, 2018:
"Purdue-based consortium works on improving freeze-drying technology"
January 19, 2018:
"Purdue research hub to transform freeze drying process used to make lifesaving drugs, preserve food"
Read all about it at
January 18, 2018: McCrone's Hooke College to offer Freeze Drying course in April 2018.
For all of the information about this course, visit https://www.mccrone.com/Lyophilization-Practical-Applications
December 4, 2017:
November 1, 2017:
Welcome to LyoHUB's newest member, Bristol-Myers Squibb. Learn more about their successes and innovations at https://www.bms.com/
October 26, 2017:
Learn more about IN-MaC and discover how LyoHUB and IN-MaC can work together to help your Indiana SME. Contact Jen at email@example.com to receive more information and schedule a meeting.
October 17 & 18, 2017:
LyoHUB participated in the IN-MaC Manufacturing Forum 2017. Click on the logo below for more information about the conference and IN-MaC
September 14, 2017:
LyoHUB is in the news! Dr. Liz Topp speaks about LyoHUB technology roadmap on Inside Indiana
September 12, 2017:
TODAY'S THE DAY! Release day for the LyoHUB Lyophilization Technology Roadmap! To Download it directly, click on the roadmap below
Read the article from Purdue Today here View the video HERE!
July 31, 2017:
A Lyo101 course was offered last week by LyoHUB featured a full 2 ½ days of training with some classroom, but primarily hands-on lab experience under the able instruction of Drs. Nail, Wegiel and Sacha of Baxter. Representatives from Mettler-Toledo and McCrone were also on hand to instruct and provide hands-on training with DSC and FD microscopy. The class was divided into teams, each with a project to work on over the 2 ½ days, with each team presenting their findings and challenges at the closing program. On Wednesday afternoon, 20 industry members from Indiana SMEs and LyoHUB members arrived for hands-on training in the LyoHUB demonstration facility followed by a day of classes on Lyocalculating, CFD, for industry as well as all of the students from the Lyo101 course. The keynote speaker for Thursday was Mike Pikal of the University of Connecticut, “Modeling in Freeze-Drying: Past, Current State and Future Perspectives”.
July 13, 2017:
WELCOME to LyoHUB's newest member, Fresenius Kabi. To learn about their products, visit https://www.fresenius-kabi.com
July 7, 2017: LyoHUB welcomes Yasmeen Solano of Cal State LA for a summer internship at the LyoHUB lab this month working on “Effects of Antifreeze Protein on the Crystallization of Common Lyoprotectants in Freeze-dried Solids”
July 1, 2017: LyoHUB's Best Practices Paper, "Recommended Best Practices for Process Monitoring Instrumentation in Pharmaceutical Freeze Drying" has been downloaded over 1,200 times! It can be accessed at http://link.springer.com/article/10.1208/s12249-017-0733-1
June 22, 2017:
Training Event for LyoHUB members at Purdue in July, 2017LyoHUB Equipment Training and PLM Software Tutorial July 26-27, 2017 Purdue University Birck Nanotechnology Center Wednesday, July 26, 1-4pm: LyoHUB demonstration facility equipment training Participants will be familiarized with: Lyophilizers Freeze Dry Microscope Mass Spectrometer MicroFD Wednesday, July 26, 6pm: Networking Dinner (provided) Thursday, July 27, all day (lunch provided): Introduction to Computational Fluid Dynamics (CFD) and Siemens PLM Software tutorial on CFD for lyophilization equipment and process analysis This workshop is designed to introduce the applications of CFD and simulation in the pharmaceutical industry as well as a range of Siemens PLM simulation tools. Attendees will also receive an overview of CFD methods and some key technologies available in STAR-CCM+. As an example we will use STAR-CCM+ to investigate fluid flow and pressure drop in a freeze dryer. The week of July 10, registered participants will receive software license in order to get familiarized with the software. During training on the 27th, participants will learn: General CFD understand and applications Introduction to CFD code Work through test cases -mail firstname.lastname@example.org with interest. Registration link coming soon. Cost: $195 Deadline: July 11 Discounted Hotel Rooms available. Ask Jen (email@example.com) for details.
June 22, 2017: Congratulations to Sajal Patel and his collaborators on the publishing of this Best Practices Paper: Lyophilized Drug Product Cake Appearance: What is Acceptable? This is now available in JPharmSci with open, free access at https://authors.elsevier.com/a/1VDZJ55JevvtJ
June 6, 2017: Welcome to the newest member of LyoHUB, Siemens Product Lifecycle Management (PLM) Software. To learn more about this global software company, visit https://www.plm.automation.siemens.com/en_us/
April 13, 2017: LyoHUB presented draft of LyoHUB Lyophilization Technology Roadmap at ISL-FD Chicago. Visit this site in July 2017 to download the final copy!
April 12, 2017: LyoHUB Annual Meeting was held at the McCrone Group headquarters in Illinois.
February 27, 2017: "The new equation for pharmaceutical lyophilisation". March 9, 2017. Live webinar. Register now! http://bit.ly/2kBj8mt” presented by Purdue & IMA
February 17, 2017: Dr. Elizabeth Topp is the co-chair for this year's Gordon Research Conference on “Preclinical Form and Formulation for Drug Discovery” will be held June 4-9, 2017 in Stowe, Vermont. The Gordon Conference website is https://www.grc.org/programs.aspx?id=15850.
January 19, 2017: LyoHUB Members are invited to call in for presentations by Dr. Celia Cruz “FDA Experience with Continuous Manufacture” and Dr. Maxwell Korang-Yeboah "Office of Testing and Research (OTR) Lyophilization Research" as well as a discussion time/ Q&A of continuous lyo.
January 11, 2017: Thank you to those who stopped by the LyoHUB poster, or referred those who were interested in learning more about LyoHUB. It was a great opportunity and wonderful to catch up with so many members!
January 10, 2017: Great LyoHUB meeting during PepTalk 2017 today. Wonderful progress was made on the Best Practices paper!
December 2016: WELCOME to Roche which has joined LyoHUB! To learn more about Roche, visit http://www.roche.com/
November 2016: WELCOME to McCrone Microscopes & Accessories! To learn more about McCrone, please visit https://www.mccrone.com/instrument-sales
November 2016: WELCOME to ABBVIE, the newest member of LyoHUB! To learn more about Abbvie, please visit http://www.abbvie.com/
September 15, 2016:
WELCOME! to the newest member of LyoHUB, ALLERGAN! For more information about Allergan, please visit http://www.allergan.com
July 15, 2016:
LyoHUB has strong presence at CPPR Freeze Drying Conference in Breckenridge, CO fro July 12-15, 2016
Dr. Elizabeth Topp presents, "High Resolution Characterization of Proteins in Lyophilized Solids"
Dr. Alina Alexeenko presents: "Heat and Mass Transfer in Spray Freeze Drying"
Drew Strongrich presents "Microscale Gas Sensing for Lyophilization Process Understanding and Control"
Steve Nail (Baxter) presents LYOHUB "Recommended Best Practices for Process Instrumentation" paper
LyoHUB Member, Arnab Ganguly (IMA Life) presents "Recommended Best Practices for Equipment Qualification" with help from LYOHUB
The following LyoHUB members also presented..
Mike Pikal (University of Connecticut) "Optimization of Primary Drying by Construction f a Graphical Design Space-Advantages and Limitations"
Lindsay Wegiel (Baxter) "Influence of Process Conditions on Spatial Distribution of Individual Vial Heat Transfer Coefficients: Implications for the Design Space"
Serguei Tchessalov (Pfizer) "Utilization of First Principles Model or Primary Drying as an Iterative Tool for Design Space Construction, Optimization and Scale Up"
June 3, 2016:
Methodology of Lyophilizers Characterization to Enable Modeling of Process Parameters During Cycle Scale Up Webinar
Date & Time: 6/21/2016 10:00 AM - 3:00 PM ET, Presenter(s): Dr. Serguei Tchessalov
Factory acceptance tests (FAT) are normally performed by manufacturer on “empty and dry” lyophilizers. Sometimes, manufacturers also perform “sublimation tests” to ensure that the condenser is capable of capturing the sufficient amount of water, specified by the user. These tests, however, might not generate enough meaningful data to enable a successful lyophilization process scale up. Drug product manufacturers often need information on heat transfer coefficients for the containers of use as well as information on capability of the dryer to maintain pressure set points at different loads.
In this presentation, the methodology of measurement of vial heat transfer coefficient (Kv) and minimum controllable pressure as a function of sublimation rate (Pmin) will be described. Kv and Pmin are key inputs in primary drying models, application of which to process design and scale up will be discussed and demonstrated.
To register for this webinar, visit http://www.spscientific.com/Webinars/
June 2, 2016:
Hold the date! We are currently putting together a great event at Purdue University for the fall, in conjunction with the CPPR meeting. Tentative dates are 10/11/16 in the evening with events all day on 10/12/16. Look for more information coming soon!
May 25, 2016:
Our first Lyo Launch Pad project is complete! Dr David Detwiler of Nanovis Inc worked on lyophilized gelatin sponge for medical applications in the LyoHUB demonstration facility.Nanovis Inc is an IN-based medical devices company and is the first Lyo Launch Pad participant. More information about their Company can be found at http://nanovisinc.com
May 19, 2016:
WELCOME! to the newest member of LyoHUB, SP Scientific! For more information about SP Scientific, please visit http://www.spscientific.com
April 14, 2016:
Please stop by and visit the LyoHUB booth at the ISL-FD Conference in Chicago on April 14, 2016. For more information about the conference, please visit http://islyophilization.org/conference-2016-chicago/
April 13, 2016:
LyoHUB will host a dinner and workshop on Wednesday, April 13, 2016 at the Big Ten Headquarters in Rosemont, IL. This event is the evening before the ISL-FD conference begins. For more information on how you can attend this event, please e-mail firstname.lastname@example.org
March 1, 2016:
WELCOME! to the newest member of LyoHUB, BAXTER! For more information about Baxter, please visit http://www.baxter.com
February 20, 2016:
The LyoHUB Demo Facility is up and running! Please see photos of the facility under the "Demo Facility" tab on this website. For more information about using this facility, please contact Alina Alexeenko at email@example.com
LyoHUB hosted a Roadmapping Workshop in conjunction with the PepTalk Conference in San Diego on January 20. For more information, click here.
LyoHUB consortium will host Lyophilization Technology Roadmapping workshop on October 6-7, 2015 in West Lafayette, IN. Read more in a story "Purdue to advance freeze-drying technology through rocket science" article released on September 29, 2015 by Purdue News.
The U.S. Commerce Department’s National Institute of Standards and Technology (NIST) selected Advanced Lyophilization Technology Consortium LyoHUB as one of 16 awards totaling $7.8 million to help accelerate the growth of advanced manufacturing in the United States. As part of Advanced Manufacturing Technology (AMTech) program, LyoHUB will assemble an expert panel of consortium members from the field of lyophilization (freeze-drying) to develop a technology roadmap that will identify critical challenges and strategies for innovation for the food and pharmaceutical manufacturing industries.
Liz Topp's group at Purdue publishes a video tutorial on high-resolution analytical methods for lyophilized proteins. "Mass Spectrometric Approaches to Study Protein Structure and Interactions in Lyophilized Powders" J Vis Exp. 2015; (98): 52503. Published online 2015 Apr 14. doi:10.3791/52503
LyoGroup's 2nd annual meeting will be held on April 8, 2015 in Chicago in conjunction with ISLFD Midwest Chapter Conference