In The Know
Welcome! Our goal is to provide you with industry updates on a routine basis. Each update of "In The Know" will bring you news of industry presentations, conferences, and educational information. 

We hope you enjoy Lyophilization Technology's (LTI) "In The Know." Look for our next quarterly update of the latest news! 
Congratulations to "LTI's Newest Project Director":  Jason Angstadt

Jason Angstadt
Jason Angstadt, Scientist I and Project Director, has been with LTI for over five years. He is responsible for project coordination from concept through clinical manufacturing, including product and process development, technical support, troubleshooting, and clinical trial material manufacturing. Jason's technical focus is dual chamber cartridge processing.

Jason joined LTI as a Development Technician I in 2013. Over the years, he has been promoted to Development Technician II, III, and his current position as a Scientist I. Before joining LTI, Jason began his career at Teleflex working in the materials test lab on the research and development of medical devices.

Jason received his Bachelor of Science in Biology and History from Albright College. He is currently pursuing his Masters in Pharmaceutical Sciences from Temple University. He has authored and presented poster presentations at focused industry events.
Another successful lyophilization conference in Garmisch, 2018

The prestigious Freeze Drying of Pharmaceuticals and Biologicals Conference was held this past month in Garmisch-Partenkirchen, Germany. A total of 22 podium presentations and 46 poster presentations were given over the two and one-half day conference. Presenters spanned leading scientists from academia and industry, all covering the latest developments in the science and technology of freeze drying. One of the conference highlights was the tributes in remembrance of Alan MacKenzie by Ed Trappler and Michael Pikal by Steve Nail.

LTI's Samantha Singer presented a poster, "Difference in Sublimation Rates and Relative Partial Pressures Measured by a Residual Gas Analyzer." LTI also sponsored Valeria Gervasi, a graduate student studying at the School of Pharmacy, University College Cork, Ireland, to attend the meeting and present her work on "Investigation into the Impact of Arginine in Lyophilized High Concentration Protein Formulations."

The conference leaders were Gerhard Winter and Wolfgang Friess from LMU Munchen with support from the organizing committee consisting of Arnab Ganguly (IMA), Steve Nail (Baxter), Sanjal Patel (Medimmune), Ingo Presser (Boehringer Ingelheim), and Ed Trappler (LTI). The next conference, again rotating between Europe and the US in two years, is planned to be held in Breckenridge, Colorado.

Particulate Detection and Location for Lyophilized Products
Recent Industry  C ontributions 

"Particulate Detection and Location for Lyophilized Products"

Carl F. Ventura, Carrie A. Shults, Edward H. Trappler

Particulate matter in sterile parenteral products is regarded as a critical quality attribute. Due to the nature of a parenteral products being essentially free of particulates is paramount in meeting the requirements of a product for injection, as listed in the USP, Sections <1>, <788>, and <790>. Inspection of any parenteral product should detect any particles or other foreign material. Particles can arise from many sources intrinsic, inherent to the product, or extrinsic, the latter arising most often from materials shed during processing. Inspection of lyo products can be extrinsic only. Inspection of lyo products occurs after lyophilization is already complete. For a lyophilized product, there is greater exposure to potential contamination due to subsequent processing. The lack of complete visibility of any particulate material within a dried cake imposes unique challenges in the inspection of lyophilized materials. This poster provides insight into the ability to detect and the behavior of particulates during the lyophilization process, this study assessed the impact of the type of particle; the material, size, and density, as well as, the influence of the nature of the solution; density, surface tension, and viscosity. Request of copy.

"Differences in Sublimation Rates and Relative Partial Pressures Measured by a Residual Gas Analyzer"

Samantha L. Singer, Carrie A. Shults, Edward H. Trappler

Lyophilization, or freeze-drying, is a process by which nearly all the water is removed from a frozen product under vacuum by sublimation, causing the ice to change directly from a solid to vapor without passing through a liquid phase.  

Sublimation endpoint determination in Primary Drying is crucial to the development of a robust lyophilization process as it directly impacts the critical quality attributes of the absence of collapse and residual moisture.

Current technologies that determine the endpoint of primary drying include direct product temperature measurement and combining chamber pressure readings of a Capacitance Manometer with a Thermocouple Vacuum Gauge. There is a growing interest in measuring the composition of the atmosphere within the lyophilizer using a Residual Gas Analyzer (RGA), a Process Analytical Technology, to ensure achieving the sublimation endpoint.

During lyophilization, measured process data indicate that the critical process parameters of shelf temperature, chamber pressure and time are within acceptable ranges. Boundary studies are performed with the intent to establish a proven acceptable range for the process.   These studies also demonstrate the robustness of the process by addressing the potential impact of processing deviations that could occur unavoidably, unknowingly or unintentionally, at conditions other than the target parameters, during routine processing. 

This presentation compares and contrasts data from conventional methods with the use of the RGA using quadrupole mass spectrometry while demonstrating the effectiveness of the RGA for defining the completion of the sublimation of ice in Primary Drying and its ability to detect differences that occur when there is a deviation from the target cycle.  
Request a copy.  

Upcoming Industry Events 

LTI wants to meet with you! Stop by our booths at any of the following events to discuss your lyophilization needs with one of our expert staff members. We look forward to meeting with you!

 Woburn, MA
Information TBA closer to event date.  
LTI will be exhibiting! Table number TBA at event.

CHI PepTalk 2019
January 14th-18th, 2019
 San Diego, CA
PepTalk:The Protein Science Week is one of the largest annual gatherings of protein science researchers in the world. Now, in its 18th year, PepTalk features renowned speakers from academia, biotech and pharma who bring global expertise and perspective to the forefront. The international delegation of over 1,300 participants convenes for intensive learning and networking to discover new opportunities, apply alternative solutions, and develop promising partnerships.
LTI will be exhibiting! Make plans to stop by our booth #507

For more events, visit our website