Life sciences, pharmaceutical, clinical and bioanalytical contract solutions provider SGS has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit (CPU) in Antwerp, Belgium and is also further strengthening its offer in the areas of infectious disease therapeutics and vaccines.
The company stated that demand in the biopharmaceutical industry for R&D in immunology and oncology therapeutics was continuing to grow, with additional parameters now required for clinical trials beyond traditional pharmacokinetic (PK) and pharmacodynamic (PD) data: research into, the collection of and the use of peripheral blood mononuclear cells (PBMC) has become a strategic and reliable analytical tool.
PBMCs are already widely used to study various aspects of pathology and biology in vitro but are now also being increasingly used in clinical studies in immunology (including auto-immune disorders), as well as in infectious diseases, hematological malignancies, vaccine development and transplant immunology. They are also used in high-throughput screening, neovascularisation, human body defence mechanism studies and the analysis of biological effects on tissue and organs and chemokine effects on adipocytes and muscles.
The use of PBMCs within clinical trials poses significant operational challenges, as the cells demand intensive handling techniques. After isolation, they must be cryopreserved immediately, and in addition have a determined timeline to be handled due to viability and recovery issues.
Haiko Pillu, Director Operations, CPU, SGS, commented: “At SGS we have been working on these specific cells and invested in the optimisation of the process for their capture and handling. This involved the development of several new clinical processes to maintain high-quality samples and flexible pathways for the use of PBMCs. One of the processes to optimise the handling of PBMCs in early-phase trials is the use of the all-in-one Cell Preparation Tubes, which, compared to the traditional Ficoll method, require less training of site staff, are less labour intensive, give better results in terms of viability and yield, and allow more time for the processing steps when conducting a clinical trial.”
SGS’s Clinical Pharmacology Director, Annick van Riel, added that the company’s expertise in using this technique, combined with its ability to manage such a sensitive parameter in early-phase clinical operations, had completed the infectious diseases and vaccines service offer that SGS had built up over many years, including the company’s CPU human challenge unit.
For further information about SGS visit www.sgs.com
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