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Walkersville, MD, United States

Rowley J.A.,Lonza Walkersville Inc.
Chemical Engineering Progress | Year: 2010

Some of the criteria that need to be evaluated during the clinical development of allogeneic cell products that require a culture-expansion step are outlined. Some of the common manufacturing platforms for current therapeutic-cell-manufacturing processes are also highlighted. The manufacturing process used to make a pharmaceutical product from a cultured cell must be capable of expanding cells in a reproducible manner with the quality attributes that are critical for product safety and efficacy. As upstream processes are scaled, the downstream processes and technology platforms must he capable of accommodating the cell and liquid volumes that are being harvested. Maximizing the number of doses produced from the master cell bank (MCB) can help to distribute the cost of safety testing across a larger number of doses, reducing the overall per-dose cost of the final product. For bioreactor cultures, the seed train would require an increase in volume, with at least one and sometimes two vessel changes.

Lonza Walkersville Inc. | Date: 2015-03-17

The invention relates to a topical composition containing a bilirubin-producing plant extract. In particular, the bilirubin-producing plant extract is obtained from the genus

Methods are disclosed for the initiation and differentiation of human embryonic stem cells (hESCs) and induced pluripotent stem cells (iPSCs) into motor neuron progenitor cells (MNPs). Methods are also disclosed for the cryopreservation of MNPs. The methods particularly relate to the simple, efficient, scalable, and reproducible generation, and subsequent frozen maintenance, of MNPs for downstream therapeutic applications. The methods can be used for the production of MNPs from various lines of hESCs and iPSCs.

The present invention provides processes for aseptically processing live mammalian cells in an aqueous medium to produce a cell suspension having a cell density of at least about 10 million cells/mL and cell viability of at least about 90%. These methods comprise a step of reducing the volume of the medium using a tangential flow filter (TFF) having a pore size of greater than 0.1 micron, during which step the trans-membrane pressure (TMP) is maintained at less than about 3 psi and the shear rate is maintained at less than about 4000 sec

Lonza Walkersville Inc. | Date: 2012-12-21

Apparatus and corresponding method for concentration and washing of live mammalian cells, for preparation of human cell therapy products. Optimized parameters for a temperature regulated, completely closed, fully disposable and scalable counterflow centrifugation separation system having integrated disposables designed for both the input cells and output cells are provided.

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