Cell culture automation has become more common in drug discovery and research applications, thereby freeing bench scientists from repetitive work as well as improving the consistency of their cell culture processes (1). Mammalian cell culture is used in the production of biopharmaceuticals, where developing a production cell line requires a large amount of repetitive manual work for bench scientists. With the increasing importance of biologics in today’s pharmaceutical market, throughput and efficiency are crucial in developing a production cell line.…
2008
Applying Good Engineering Practices to the Design of Single-Use Systems
Significant changes are being incorporated into biopharmaceutical manufacturing processes as a result of drivers such as increasingly strict regulatory demands, reduction of manufacturing costs, and outsourcing to contract manufacturing organizations (CMOs). Historically, many biopharmaceutical processes were designed and built based on cleanable, reusable stainless steel systems and unit operations. Today several industry drivers are shifting some unit operations toward single-use technologies, namely lowered cross-contamination, reduced capital investments, and desired further reduction in manufacturing costs and shortened drug development times (1,2,3).…
Why Do So Many Biopharmaceuticals Fail?
Biopharmaceutials and the processes used to make them are exceedingly complex, and the path to developing new therapeutics is a high-risk endeavor. The emphasis today is on controlling product quality, safety, and efficacy through understanding biological mechanisms, key product attributes, and process parameters. Such information is also crucial for guiding development efforts to improve chances of success in the clinic and for gaining regulatory approval. Analytical methods provide the foundation for acquiring such knowledge. Efforts devoted to developing meaningful and…
2008 in Review
As the Chinese calendar warned us, it did indeed turn out to be a year of the rat. If you‘re in any doubt about the economic crisis of 2008, here’s a single significant indicator: Pharmaceutical companies’ spending on advertising declined this year for the first time in history. Walgreen’s CEO Jeffrey Rein was quoted in FierceBiotech as calling 2008 “the tightest market for prescription drugs” in his 27-year career. If big pharma and big retail were feeling the pain, of…
Monitoring ATP Status in the Metabolism of Production Cell Lines
Development of industrial cell culture processes for production of recombinant proteins seeks high efficiency, reproducibility, and predictability. Usually the time allowed for process development is short, during which culture conditions and scale-up protocols must be defined so as to maximize cell productivity and yield while minimizing process scope and overall costs (1). Although scientific literature describes various methods that increase productivity of a cell culture by reducing and arresting cell growth or weakening cell physiology (2), the cells must be…
Quality Assessment in 3D Cultures of Disc-Chondrocytes
Autologous chondrocyte transplantation is a modern experimental therapy for treatment of degenerative intervertebral disc diseases. Several studies with animal models have shown that transplantation of cultivated autologous chondrocytes can delay progression of disc degeneration. A few products based on human autologous chondrocytes are already on the market. Repair of disc damages with grafted chondrocytes appears feasible in the near future. So chances are growing for clinical applications meant for restoration of original disc function. As a result, optimization and standardization…
Quantifying Trends Toward Alternatives to Protein A
Problems associated with affinity purification in antibody production continue to increase as upstream cell culture expression levels improve. As a result, many vendors and users in the biopharmaceutical industry are working to identify alternative technologies that can replace tried-and-true column chromatography. In the fifth annual report and survey by BioPlan Associates, 434 global respondents pointed to bottlenecks created by downstream processes as one of their most serious manufacturing problems today (1). Amost two-thirds (63.8%) said their facility is experiencing some…
Antibody Development and Production Conference
IBC’s Antibody Development and Production conference will help you evaluate the latest scientific and technical approaches to successfully accelerate the development of robust processes. This event is regarded by the industry as the most comprehensive event that brings you best practices across the spectrum, including the most critical stages of upstream and downstream processing. Keynote Presentations “How Do We Get to 30 g/L Using Fed-Batch Technology? What Are the Limitations?” by Thomas Ryll, director of cell culture development at Biogen…
Products, Services, and Literature
Disposable Bags Product: Bioprocessing bags Applications: Containment, mixing, and so on Features: Flexel 3D standard bags are designed for processing, storage, and transport of large-volume biopharmaceutical solutions. These disposable bags fit Sartorius Stedim Biotech’s Palletank containers or commonly available plastic drums. The bags provide a single-use alternative to traditional stainless-steel vessels in a range of applications. Standard Flexel 3D bags come as sterilized and ready-to-use stand-alone bags or filter-and-bag assemblies that incorporate a range of tubing, connections, filters, and bag…
Achieving High-Efficiency Production with Microbial Technology in a Single-Use Bioreactor Platform
Major efforts are under way to develop new, high-efficiency, cell-based expression systems and flexible low-cost biomanufacturing platforms for biotherapeutics and vaccines to drastically reduce development and manufacturing times. The industry’s enormous growth is driving many of these efforts. The global market for biotherapeutics now stands at $80 billion. Resurgent interest in vaccines is coupled with recent failures in current vaccine manufacturing technologies and the advent of cell-based vaccine manufacturing. The emerging class of follow-on biologics will create additional demand for…