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.
There has been a huge increase in single use apparatus in the biopharmaceutical manufacturing world during the last. Many companies compete in manufacturing production tools. At Boccard where our mantra is “In Stainless Steel We Trust”, we have a different opinion. We believe that plastic and stainless steel are complementary. Let’s take the example of cell culture. Before growing in a huge fermenter (e.g. 1000 L), what is the point of using a stainless steel 20 L fermenter as a first step from an economical point of view? why not use Single Use apparatus in this case?
Mesenchymal stem cells (MSCs) are attractive candidates for therapeutic applications, especially in the field of regenerative medicine [1] 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 [2]. One of the most important challenges in providing hMSCs for curative use is the production of large quantities of cells in a robust manner.
