This is a newsletter from NextBioForm, a center coordinated by RISE with the goal to deliver better formulations for biopharmaceuticals. From the long-term perspective, our goal is to create stable biopharmaceuticals that will improve the quality of life for patients.
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| We are approaching Christmas and the end of the year, and it is time to look back at the year that has passed. It has been an exciting and interesting year for NextBioForm, where a lot has happened in research and other activities. |
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| During spring and into autumn, SweDeliver and NextBioForm have been planning for the New Horizons in Drug Delivery and Formulations 2023 conference, which took place in the last week of November at Uppsala Concert and Congress in Uppsala. |
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As we approach the new year, we would like to highlight the exciting developments taking place at NextBioForm. Some of our students are beginning to prepare for their upcoming thesis defenses.
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Freeze drying is a commonly used method for preserving probiotic bacteria and live biotherapeutic products. Before drying, the bacterial cells are formulated with a lyoprotectant, and the design of these two process steps are crucial to achieve a high-quality product.
There are several factors that may affect the biological and physicochemical properties of the freeze-dried cells and we have used a Design of Experiment approach to investigate the effects of formulation and freeze-drying parameters on properties and performance of Limosilactobacillus reuteri R2LC. The biological characteristics of the dried bacteria were evaluated by measuring cell survival, metabolic activity and stability, and physicochemical characteristics were studied using visual inspection, differential scanning calorimetry (DSC), scanning electron microscopy (SEM), and analysis of residual moisture content and bacterial aggregation.
A comparison between the lyoprotectants trehalose and sucrose showed that the latter gave better freeze-drying survival, metabolic activity, and storage stability. We also want to highlight that there was a correlation between bacterial concentration, metabolic activity, and aggregation of bacteria, where a higher concentration (1010 CFU/mL) resulted in both higher metabolic activity and aggregation.
Several other process and formulation factors affected both the biological and physicochemical properties of freeze-dried Limosilactobacillus reuteri R2LC and it could be concluded that care must be taken to develop a production method that generates a product with high and consistent quality. These results may, or may not, be strain specific.
Authors: Nisha Tyagi, Zandra Gidlöf, Daniel Tristan Osanlóo, Elizabeth S. Collier, Sandeep Kadekar, Lovisa Ringstad, Anna Millqvist Fureby and Stefan Roos
Link to the publication → |
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