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Lyotherm3 - Frozen state impedometer

Identifying & Understanding Temperature Transitions in Frozen State Solutions

A knowledge-based approach to designing and developing successful freeze drying formulations and cycles requires information about how the product responds to different processing conditions. Candidate formulations should be analyzed in terms of their visible physical structure, thermal characteristics and frozen state mobility, in order to gain a sufficient understanding of its behaviour throughout the freeze drying process.  This ensures that cycles can be developed that are tailored to the specific needs of every product, making them efficient, safe, robust and reproducible.

Optimisation of the lyophilisation process starts with a deep understanding of the Active Product Ingredient (API) being used and its interaction with excipients. Knowledge of phase transitions occurring in the frozen state directly leads to efficiency and promotes stability during and after the lyophilisation process. One of the most powerful methods used to find these phase transitions is Zsinϕ analysis, performed using the Lyotherm3.

The Lyotherm3 identifies the temperature that transitions occur at using variations in Zsinϕ, a function of electrical impedance, and supplements this with differential thermal analysis (DTA). As Zsinϕ is a metric of molecular mobility this is sensitive enough to identify protein folding and other small reorientation events.



Determining critical temperatures is fundamental to our intelligent freeze drying philosophy. Find out how Lyostat and Lyotherm can inform your cycle development process

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Decades of practical process experience

We are outsourcing our product for testing often[…] and getting the satisfactory results from [Biopharma] the company; also availing the additional benefits. We [are] assured to continue the same rapport with your esteemed organization. Thank you for your timely support.

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“I worked with BTL and they provided an excellent service to Waters at the development phase of our project.

Both Dr. Laura Ciccolini and Mr. Nick White were very helpful and professional, [they] not only assisted me with the project but also gave me an understanding of the Freeze Drying process. The personnel at BTL are the experts in their field of freeze drying and really supportive to me as a client in our development phase and were really focused in adding value and optimising the process throughout.

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“I would like to give my appreciation for the great service that we received from you [BTL] last year.

When I first contacted your company, my intent was to register myself to one of your Lyo course, unfortunately the regular course schedule didn’t meet my needs so Dr. Laura suggested to try and arrange this course here in Israel. After few email to my colleagues, I was [surprised] to see the actual demand that I got for this course, at the end, I found myself arranging Lyo Bespoke Course for more than 30 colleagues across 3 sites.

Due to Dr. Laura help and dedication, we were able to arrange this course in 3 months […]. The course was great and it met our needs.”

M. Alon

Senior Project Engineer - Omrix Biopharmaceuticals Ltd. Israel

“[Research Scientist] Mervyn did a great job, and we learned useful things about some of our samples during the install and training. We’re excited to have this new tool at our disposal.”

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Krutika Invally

Evelo Biosciences - USA

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