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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The field of biologics has been expanding during the last years and in particular in the area of vaccines, including both the novel mRNA vaccines and protein-based vaccines.
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The consortium meeting occurred three weeks ago, and we were very happy to see you all! More than 30 people travelled to Sigtuna, while another 8 people joined us online. This autumn meeting was focused on our young scientists, who all presented their newest findings and future plans.
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Lars Nilsson and Hans Bolinsson both work at the department of Food technology at University of Lund, where they have been developing the method called asymmetric flow field fractionation (AF4). Together with Christopher Söderberg at CoSAXS, they have now tried to couple the AF4 to the CoSAXS beamline in a recent experiment.
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Authors: Daniel Tristan Osanlóo, Jonas Fransson, Björn Bergenståhl & Anna Millqvist-Fureby |
In the world of solid formulated biologics structure and activity are important factors to preserve, and the matrix dictates conditions for if the solid biologic is successfully preserved or not. This article explored drying techniques’ role on the solid placebo-matrix, consisting of a stabilizer and a scaffolder. Furthermore, the article assessed how the interplay between stabilizer and scaffolder affected the characteristics of the solid placebo-matrix, in relation to drying technology, and why the different matrixes was rendered as successful or detrimental. Moreover, the article provided necessary knowledge for future work since the authors plan to include an active biologic in the formulation. Therefore, it is of utmost importance to understand how stabilizers, scaffolders and drying conditions are predicted to influence the solid matrix and in the end the quality of the final biologic formulation.
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Authors: Palmkron SB, Gustavsson L, Wahlgren M, Bergensthål B, Fureby A |
A common issue of freeze drying is the inhomogeneity between samples. The purpose of this study is to address this issue. The temperature and the heat transfer was measured using different setups, both with and without vial holders at various positions at different shelf temperature and chamber pressures. When no water was removed the sample temperature increased each time the pressure decreased see figure 1. Using vial holder reduces the deviation between the samples but have limited effect on the temperature increase. The temperature increase and the sublimation rate was highest close to the door and walls of the freeze dryer, sublimation rate is presented in figure 2. After calculations we found that about 65-75% of the heat is transferred by conduction and 25-35% by radiation under normal operational conditions.
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Authors: Ingrid Ramm, Mats Leeman, Herje Schagerlöf, Ileana Rodríguez León, Alejandra Castro & Lars Nilsson |
Therapeutic proteins are of increasing importance for health care and the treatment of variety of diseases. However, therapeutic proteins are large, complex, and sensitive. A novel analytical in vitro method, combining Asymmetric Flow Field-Flow Fractionation (AF4) and mass spectrometry (MS) has been developed that gives insight into the behaviour of therapeutic proteins in vivo. AF4 provides valuable information on the size of analytes and MS enables selective detection and quantification. In the study it is shown that after incubation of proteins in plasma, the developed method can be used to investigate and quantify serum albumin binding, analyse changes in monoclonal antibody size, and that monoclonal antibody aggregates can be identified and quantified.
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