MSCs Expansion in Spinner Culture: MSCs tended to clump once higher densities were reached in microcarrier spinner cultures (Days 5-10).
Pharmatainer™ products are currently manufactured in PC and PET in sizes from 125ml to 20 liters.
Cellon opened its state-of-the-art production moulding facility in Luxembourg in 2011.The plant is 100% dedicated to production of clean, single- use products for use in the vaccine andbio-processing sector, and operates under an ISO 9001-2008 quality system..........
Cellon SA announced that their entire range of PharmaTainer™ bottles and carboys are now certified “clean,” meeting USP 788 Particulate Matter in Injections, and the equivalent EP and JP quality standards
SOLOHILL Microcarriers for
Mesenchymal Stem Cell Expansion :
Mesenchymal stem cells (MSCs) are self-renewing cells that differentiate into several terminally differentiated cell types. These cells have been isolated from multiple sources such as bone marrow, adipose tissue, peripheral blood, and other adult issues. The interest in these cells is that they hold the potential to cure disease and are being pursued in clinical trials. Three emerging fields of interest for stem cells are toxicology screening for drug development, cell therapy and regenerative medicine.
In many cases, poor correlation between efficacy of candidate drugs in animal models and humans is observed. This leads to high attrition rates of candidate drugs from the developmental pipeline and also contributes to large losses in revenue spent on animal model testing....
USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections will be published for public comment before year-end.
This chapter discusses strategy and methods for characterization of the protein aggregates and particles in biotherapeutics. While initial limits for subvisible particles will likely be the same as in USP<788>, there may be a requirement to monitor (but not report) particles less than 10µm.
Included in the chapter is guidance concerning injectables that typically have inherent particulate burden i.e. those with adjuvants, or high protein concentrations prone to aggregation. Such preparations typically would not meet guidelines using standard particulate testing procedures such as light obscuration. In these cases, it is anticipated that regulators will be looking at manufacturing processes to ensure that particulate contamination is avoided wherever possible and that the finished product is fully described and defined in terms of the expected particulate load in product submission documents.
This biologics specific chapter includes considerations of smaller volume, appropriate sample handling and a focus on protein aggregates rather than just extrinsic and intrinsic particles.1