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
At Ferring Pharmaceuticals, Peptides And Proteins Make Significant Advances
Dr. Keith James joined Ferring Pharmaceuticals as VP of Therapeutic Innovation in early 2012. In December 2012 he was promoted to president of the Ferring Research Institute and SVP of R&D for Ferring Pharmaceuticals. Prior to joining Ferring, Dr. James spent 29 years working for Pfizer, with significant time spent in discovery research. At the 2013 Oligonucleotide & Peptide Based Therapeutics Congress he will speak on recent progress and future prospects in the peptide and protein therapeutic space. I recently spoke with Dr. James to get an overview of the potential in this market.
Fundamentals Of Viral Clearance Studies Part 4: Considerations For Evaluating Viral Clearance By Chromatography Steps
Chromatography steps are typically the backbone of the purification process for a biopharmaceutical product, and are usually included in the evaluation of the viral reduction capacity of a manufacturing process. In viral clearance studies of chromatography steps, the capacity of the chromatography resin to provide physical separation of the spiked virus from the product fraction is determined. Viral reduction by chromatography steps is considered less robust than by other less complex steps, such as inactivation steps. By Kathryn Martin Remington, Ph.D., Principal Scientist for Clearance Services, BioReliance
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Golden Rules For Working With Cell Cultures
Susi and Adi know from their own (sometimes bitter) experience the sort of things that cause problems for them and their colleagues in cell culture bottles in the lab.
Scale-Up Of Microbial Fermentation Using Recombinant E. Coli
Fermentation production facilities can utilize the Thermo Scientific™ HyPerforma™ Single-Use Fermentor (S.U.F.) instead of traditional stainless steel cleaning-in-place/ sterilization-in-place (CIP/SIP) fermentor vessels without modifying their existing procedures.
Adaption Of The BioLector Technology To Anaerobic Requirements
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.
Batch Culture Of CHO Cells In The Multifors Cell
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.
Skip Steps In Cell Culturing
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.
Capture And Purification Of Recombinant Albumin Fusion Proteins Using AlbuPure®
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.
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Biologics Research Promises To Bolster Future Of Medicine
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 Initiates Phase I Clinical Trial With Anti-MIF Antibody In Patients With Solid Tumors
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.
Eureka Genomics Awarded Multi Year Contract To Assist Military Laboratory With DNA Sequencing
Based on collaborative work done for the past twelve months with the Armed Forces DNA Identification Laboratory (AFDIL), Eureka Genomics has been awarded a multi-year contract with AFDIL to provide forensic service support that should advance efforts to identify unknown remains from the Korean War.
Lilly's Anti-IL-17 Monoclonal Antibody, Ixekizumab, Met Primary Endpoint In Phase II Study In Patients With Chronic Plaque Psoriasis New Phase II data, published today in the New England Journal of Medicine, showed that Eli Lilly and Company's (NYSE: LLY) ixekizumab (pronounced ix" e kiz' ue mab, previously known as LY2439821), an anti-IL-17 monoclonal antibody, met its primary endpoint in patients with moderate-to-severe plaque psoriasis, with significantly more patients achieving at least a 75 percent improvement in Psoriasis Area and Severity Index (PASI) scores from baseline (PASI 75) compared with placebo at week 12.
Argen-X Launches NHance™ Technology To Generate Better Human Antibody Therapies arGEN-X announces today the launch of NHance™, its latest cutting-edge technology enabling the creation of truly differentiated human antibody therapeutics.
Roche´s MagNA Pure LC 2.0 System For Monitoring DNA In Therapeutic Proteins And Monoclonal Antibody Drugs To ensure product safety, clearance of host-cell DNA is essential when manufacturing therapeutic proteins and monoclonal antibody (mAB) drugs.
Xencor Receives U.S. Patent For Monoclonal Antibody Engineering That Extends Duration Of Action Xencor, Inc., a company using its proprietary Protein Design Automation® (PDA) platform technology to engineer next-generation antibodies, announced today that the U.S. Patent and Trademark Office has issued Xencor a broad patent covering optimized monoclonal antibody variants and their application for extending in vivo half-life of antibodies.
DSM Expands Its Innovative Biomanufacturing Technology Portfolio With The Introduction Of The New Kremer Method™ Royal DSM, the global Life Sciences and Materials Sciences company, today announced the introduction of the Kremer Method™, an innovative proprietary technology developed by DSM scientists which improves downstream processing of monoclonal antibodies (mAbs) for faster and more cost effective production of biopharmaceuticals.
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.