Scientists and engineers seeking to develop manufacturing processes for new biopharmaceutical drugs face a number of challenges. Upstream process development must deliver a high-yielding cell culture to meet Cost of Goods (CoGs) objectives. The process must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance. The biological product must maintain the required product quality attributes, during scale-up from laboratory to commercial scale. Biopharmaceutical companies must address these complex challenges in the shortest possible timeframe and at reasonable effort and cost during development. Doing so allows the early evaluation of products in the clinic and, therefore, effective resource allocation behind projects from the pipeline that are most likely to be successful all the way to the market.
Automation and disposable technology have offered considerable efficiency improvements to speed cell line development; however, a major challenge with process development for biologics is how labor intensive it can become. Many different interactions and parameters can impact product quality and product titer, which typically requires iterative rounds of statistical experimentation using up to 20 reactors or more per study. For cell culture mAb processes, this development work can take three to four months to complete, which adds considerable cost for a company in multiple ways. Because of this challenge, Dr. David Pollard, executive director of BioProcess Technology & Expression, BioProcess Development at Merck, and his dedicated technology group wanted to see how the benefits of automation and disposable technologies could be translated into tools to drive high throughput upstream process developmen
Biopharmaceutical manufacturers can suffer significant financial losses as a result of a Mycoplasma contamination in a cell culture. Preventing this, though, is easier said than done. Andy Kelly reveals more about the structure of these troublesome microorganisms and detail a study to determine the link between filtration pressure and Mycoplasma retention rates.
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.
With Cell Culture Flask Adapters, the culture can be centrifuged directly in the flask. Data illustrates that cell yield, cell viability, and endpoint analysis results are comparable when cell cultures are processed traditionally or centrifuged directly in the flask using Cell Culture Flask Adapters.
Human serum albumin (HSA) has a vast array of applications within the BioPharmaceutical industry including; plasma expansion, formulation excipient, drug delivery, wound healing as well as extending the half-life of a protein drug as a fusion partner.
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.