Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach. Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.
The understanding of lab-scale processing, from cell and media type to bioreactor size and scale-up, is a vital part of its development. This article reviews the key steps and considerations to aid in developing the process while keeping costs down.
Upstream processes must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance.
With the continuing move of the biopharmaceutical and cell therapy industries toward the use of animal component- free materials in biomanufacturing processes, Pall Life Sciences has added a new, animal component-free microcarrier to its already extensive portfolio. Introducing Star-Plus, a rigid, spherical, low density microcarrier, featuring a proprietary chemistry built on the SoloHill® polystyrene core resulting in one of the fastest-attaching microcarriers available for many cell types under a variety of environmental conditions.
mAbs are produced for a number of therapeutic applications. However, mAbs are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate. Additionally, the contaminant HCP content is process-dependent.
Mycoplasma maybe the smallest class of free living microorganism, but the consequences of a contamination in a cell batch during bioprocessing can be huge.
This case study explains how Parker Domnick Hunter (a division of Parker Hannifin) helped a pharmaceutical company optimize cell density in cell culture tanks that needed to be converted into fermenters to grow E. coli bacteria.
Biorefineries have reignited interest in anaerobic fermentations with biobutanol production being the principle driver. Already during the First World War Biobutanol and acetone were produced in Clostridium acetobutylicum.
The Multifors Cell can be used to easily optimise development processes by parallel cultivation of animal cell cultures. Cultivation of the CHO (Chinese hamster ovary) cell line in the Multifors Cell bioreactor (INFORS HT, CH-Bottmingen) is described in the following as an example of batch cultivation of parallel samples.
America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA).
Baxter International Inc. has begun dosing patients with malignant solid tumors in a Phase I clinical trial of a monoclonal antibody, representing the company’s efforts to extend its oncology portfolio with advanced biological research and development.
Cell culture is a complex, highly structured process for growing cells, under strictly controlled conditions, outside of their normal environment. Cell cultures stilluse cultures of cells on flat plastic dishes.
This is referred to as two-dimensional (2D) cell culture. Aside from using Petri dishes for growing cells, scientists have for a long time, grown cells within biologically-derived matrices such as collagen or fibrin.
Today, more and more 3d cell cultures are being used because they more closely resemble the in vitro cell growth environment. Most 3d cell cultures in use today are designed for stem cell research, tissue engineering and drug discovery. As the field continues to grow and expand, 3d cell culture availability will likely expand to include other cell culture related fields.
For non-adhesive cells suspension cell cultures are used. In these cultures a cell is placed in the liquid suspension, stirred with a magnetic stirrer to agitate the cell and make it float freely in the suspension. The cell grows, divides and spreads throughout the suspension.
Cell culture refers to the culturing of cells derived from multi-cellular eukaryotes (cells with a nucleus), primarily animal cells. However cell cultures also exist for plants, fungi and microbes that include viruses, bacteria and microorganisms. Cell culture shares closely related methodology with tissue culture and organ culture.
You can separate cells from tissues for use in cultures several ways. Cells can be purified from blood but only white cells will grow in a culture. Mononuclear cells can be released from soft tissue using enzymes that break the cells away from their substrate or matrix. Pieces of tissue can also be placed in a growth media and the cells that grow from it can be used for cell cultures.