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: 2016-06-13
The current disclosure provides methods for reprogramming mammalian somatic cells by regulating the expression of endogenous cellular genes. Cellular reprogramming of somatic cells can be induced by activating the transcription of embryonic stem cell-associated genes (e.g., oct3/4) and suppressing the transcription of somatic cell-specific and/or cell death-associated genes. The endogenous transcription machinery can be modulated using synthetic transcription factors (activators and suppressors), to allow for faster, and more efficient nuclear reprogramming under conditions amenable for clinical and commercial applications. The current disclosure further provides cells obtained from such methods, along with therapeutic methods for using such cells for the treatment of diseases amendable to stem cell therapy, as well as kits for such uses.
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.
Lonza Walkersville Inc. | Date: 2011-05-03
An apparatus and processes for aseptically dispensing live mammalian cells into sterile, flexible bags in a non-sterile atmosphere. The method includes the steps of: providing the cells suspended in a liquid; providing a plurality of sterile flexible bags fluidly connected to a main line by a plurality of branch lines of sterile flexible tubing; evacuating air from the flexible bags by applying a vacuum to the open end of the main line; preventing fluid flow through all branch lines except that of one bag to be filled; dispensing a desired volume of cell suspension into the open end of the main line; and introducing sufficient sterile purging gas under pressure into open end of the main line to drive into the bag any of the dispensed volume remaining in the main line or branch line of filled bag. Cells can be cryogenically preserved in the filled bags.
Lonza Walkersville Inc. | Date: 2013-06-11
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.
Lonza Walkersville Inc. | Date: 2012-09-28
Methods and kits are disclosed for distinguishing viable from nonviable microbial cells. The methods and kits are useful in the screening of cell culture formulations and the testing of preservative efficacy. The methods involve the amplification and quantitation of microbe-specific DNA from precursor rRNA or Elongation Factor 3 mRNA in treated versus nontreated test samples using the reverse transcription polymerase chain reaction.
Lonza Walkersville Inc. | Date: 2012-12-19
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 Strelitzia. When topically applied to skin, the composition is effective in accelerating the degradation of heme by-products such as bilirubin present in the skin.
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 Stelitzia. When topically applied to skin, the composition is effective in accelerating the degradation of heme by-products such as bilirubin present in the skin.
Lonza Walkersville Inc. | Date: 2012-07-19
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^(1). The invention also provides a complete process for large scale manufacturing mammalian cells for use in a therapeutic composition, and scalable, fully disposable systems for carrying out the process, using readily available disposables and pumps.
Lonza Walkersville Inc. | Date: 2013-11-01
Methods and compositions for improved cellular reprogramming to generate induced pluripotent stem cells.