• The importance of cycle parameters in lyophilisation & why one size does not fit all

Laboratory Products

The importance of cycle parameters in lyophilisation & why one size does not fit all

Feb 28 2023

Freeze drying has become a popular technique across a variety of industries including, but not limited to, diagnostics, pharmaceutical, biotech and food to name a few, all of whom use freeze drying in the processing of their products in different ways.

Why are the parameters of cycle development variable?

Before a sample can be freeze dried (lyophilised), the freeze drying cycle must be carefully designed to produce optimum conditions for the final product. As consumers and buyers of freeze-dried goods, we often take this for granted but there is a lot that is taken into consideration and occurs behind the scenes to meet the product quality attributes in terms of product stability and functionality.

A commonly occurring misconception for cycle design and development we have heard numerous times is that “This cycle works well for this product; it can be applied to other products we have’”. Unfortunately, this is rarely, if ever, the case, so we cannot emphasise enough the importance of the role of designing lyo-cycle parameters during cycle development that are suitable for your desired end-product.

At Biopharma Group, dedicated in-house project managers and lyo scientists communicate and collaborate with our clients throughout the development and processing stages of a project from start to finish, to produce the best possible conditions for developing an effective freeze drying cycle. 

The process begins by determining the critical temperatures specific to client’s sample/s using the pre-lyophilised material. These parameters are obtained using analytical lyo instrumentation including the Lyostat (freeze drying microscope), Lyotherm (combination of differential thermal analysis and electrical impedance) and frozen state (pre-lyo) Differential Scanning Calorimetry (DSC) analysis. Based on the results of the initial thermal characterisation, a series of developmental cycles with associated post process analyses to fine tune the process parameters, followed by a confirmatory cycle to evaluate the process repeatability.

The benefits of an advanced and fully developed freeze drying cycle by Quality by Design (QbD) include:

  • The removal of a “trial and error” approach, which removes batch failures/product rejection and reduces the overall processing and production costs
  • Time saving, especially when the lyo process is transferred and scaled up.
  • An increase in product stability and shelf life
  • Increase in acceptable storage temperature, leading to a reduction in costs, since the cold chain is removed.
  • Improved appearance and robustness of freeze-dried cake or lyobead
  • Faster reconstitution times.

To discuss your cycle development requirements, please get in touch or visit or website.

Digital Edition

MAC Guide 2023/24

December 2023

Buyers Guide - Major producers of analytical equipment who wish to introduce and sell their products to buyers in science and industry - Over 1,000 products and services that these companys man...

View all digital editions


Instrumentation Live

Jan 17 2024 Birmingham, UK

Smart Factory Expo 2023

Jan 24 2024 Tokyo, Japan

Arab Health

Jan 29 2024 Dubai, UAE

Nano Tech 2024

Jan 31 2024 Tokyo, Japan

SLAS 2024

Feb 03 2024 Boston, MA, USA

View all events