Expansion of Human Bone Marrow-Derived Mesenchymal Stem Cells in BioBLU 0.3c Single-Use Bioreactors (La Vague 53)
Mesenchymal stem cells (MSCs) are attractive candidates for therapeutic applications, especially in the field of regenerative medicine  because – in contrast to embryonic stem cells – they do not pose ethical issues, they can be isolated from various tissue sources, and they reduce the risk of rejection reactions. The doses of human MSCs (hMSCs) needed for clinical trials are estimated at between one and 200 million cells per patient, depending on the disease being tackled . One of the most important challenges in providing hMSCs for curative use is the production of large quantities of cells in a robust manner.
Many industries including those associated with generation of power and the manufacture of glass, steel and petrochemicals etc. have demonstrated that continuous manufacturing provides significant benefits and advantages, ranging from reduced capital and operating expenses to greater efficiency and product quality and consistency.
Following to questions raised by French Biotech industry on GMP part I and II cleavage proposed by inspectors regarding biological production process, the objective of this article is to propose a clarification in the particular case of biological active ingredients when formulation is performed during Drug Substance manufacturing instead of during Drug Product manufacturing. This apply fully to recombinant proteins and monoclonal antibodies and case by case to other biotechnology manufacturing processes and innovative therapeutic (vectors of gene therapy and vaccines,…)
"Close Collaboration Maximizes Value of Engineered Solutions and Saves Time in Start-Up" (La Vague 53)
The case study of BioMarin Fast Track project with Verdot Ips²
This paper reports a very fruitful collaboration between a Biopharmaceutical company, BioMarin International Ltd and a manufacturer of purification equipment, VERDOT Ips², which contributed to a fast start-up of an installation for manufacturing a recombinant human tripeptidyl peptidase 1 (rhTPP1), for the treatment of neuronal ceroid lipofuscinosis Type 2 (CLN2) disease, also known as Batten Disease.
Low Endotoxin Recovery (LER) is today one of authorities serious concerns regarding pyrogen testing (La Vague 53)
Low Endotoxin Recovery (LER), initially described by Chen and Vinther in 2013, is a phenomenon occurring in protein formulations that is characterized by efficient masking of Lipopolysaccharides (LPS/endotoxin). Depending on the protein - buffer characteristics, the temperature - and time - dependent masking effect can lead to complete non-detectability of LPS, which might present a serious risk for the patient. At first being interpreted as a purely artefactual event occurring in testing laboratories, LER is today one of FDAs serious concerns regarding pyrogen testing.