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