Malvern, United Kingdom and Martinsried/Munich, Germany, March 1st 2021
Malvern Panalytical Ltd and Leukocare AG today announced an exciting collaboration which will improve the availability of vaccines for COVID-19. They will combine Leukocare’s pioneering expertise in biopharmaceutical formulation development with Malvern Panalytical’s extensive analytical knowhow to understand how the stability of vaccines can be improved, increasing production and simplifying distribution.
Dr. Andreas Seidl, Chief Operating Officer at Leukocare, commented, “I am excited and thankful to start this collaboration in these unprecedented times. While we have already seen tremendous efforts and several successes on approvals of vaccines targeting the COVID-19 pandemic in the past few months, there still is a high unmet need for improved stability, supply and storage conditions to serve the vast majority of people and countries over the upcoming months and years. Our collaboration with Malvern Panalytical will help us to work even better on our ongoing and future projects to achieve stability improvements for a range of vaccines.”
Mark Fleiner, President of Malvern Panalytical, also expressed excitement about the opportunities presented by this project. “We have all experienced the impact of the current COVID-19 pandemic on the lives of our families, friends and work colleagues” stated Mark. “The availability of vaccines brings hope to us all – so we jumped at the opportunity to be involved in this deep collaboration with Leukocare working together to understand how vaccine stability can be improved and ensure wider availability.”
Profiling and optimization of colloidal and thermal stability of biologics is at the center of Malvern Panalytical’s technical solutions and expertise, with Dynamic Light Scattering, multi-detector size-exclusion chromatography, and Differential Scanning Calorimetry (DSC) providing the complementary data required to drive formulation development. MicroCal DSC is a gold standard technique for assessing thermal stability and facilitating the selection of stable formulations and has been used in the development of a wide range of biologics from recombinant proteins and vaccines to viral vectors and lipid-based drug delivery systems.
Leukocare AG, located in Martinsried/Munich, Germany, is a biotechnology company specialized in the field of biopharmaceutical formulation development. Operating at the interface of drug substance and drug product development, Leukocare combines sound knowledge of formulation development with bioinformatics and artificial intelligence.
The formulation development approach consists of two elements: a library of up to 100 different regulatory well-established and employed excipients and a rational development approach that employs statistical software and self-learning algorithms as well as state of the art design of experiment (DoE) matrices. By utilizing the artificial intelligence elements, Leukocare is able to specifically combine excipients leading to stabilizing formulations tailored to the drug product’s needs. Leukocare’s superior and innovative drug product formulations can be applied to a broad range of applications: biologics & biosimilars, vaccines & viral vectors and biofunctionalized devices.