Figure 1. The pharmaceutical industry has relied on laboratory testing for all of the past century. Typically, biopharmaceuticals are manufactured in batches and tested for quality using off-line laboratory test methods of samples extracted from the process line. However, taking the laboratory to the sample changes the way analyses are conducted. The FDA Guidance for industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, promulgated in final form in September 2004, encourages the use of available process…

Figure 1. AmProtein Corporation is a biotechnology powerhouse that has revolutionized the biologics industry with the discovery of a novel expression vector and development of a disposable bioreactor series. AmProtein has used these two discoveries to develop an unbelievably simple and efficient, industrialized CHO cell protein production platform. This platform includes a revolutionary expression vector; a single-use, plastic bag-based bioreactor system based on a novel, patented O2 transfer method; and serum-free cell culture media. The platform is scalable from bench…

Who Is Advanced Scientifics? Advanced Scientifics is an ISO 13485:2003, FDA registered global leader in the design and manufacture of single use systems for the Pharmaceutical and Biotech industries. Our vast array of manufacturing capabilities allows us to provide a custom disposable system in some of the industry’s shortest lead times. From system design, to the highest standard in quality production and assembly, to final packaging and sterilization, advanced Scientifics is your complete single use systems provider. Facilities Advanced Scientifics…

Figure 1. The costs of producing monoclonal antibodies (MAbs) from mammalian cells are extremely high. Producing 500 kg/year of a MAb can run $200,000,000/year or more. Great effort has been made by the biopharmaceutical industry to reduce these costs. Companies have improved or expanded their existing infrastructures for MAb manufacturing, optimized media formulations and feeds, and/or genetically engineered production cell lines, with the current industry goal of 10 g/L titers and productivities of 100 picograms/cell/day. A twofold increase in volumetric…

Figure 1. Single-use components are finding more use in the biopharmaceutical industry. One application increasing in use is transportation of sterile liquids. There are many challenges to consider when shipping a flexible container with sterile liquids. Typical Bio-Containers used in shipping applications are constructed of multiple layers. The fluid-contact layer is typically constructed of low, linear low, or ultralow density polyethylene (LDPE, LLDPE, or ULDPE). A variety of gasbarrier layers can be used in construction of the multilayer film, and…

Emerging lifestyle diseases and an aging population are creating a number of major health challenges. Over the past few years, the food industry has been more focused on functional foods, those intended to be consumed within the normal diet but containing biologically active components with physiological benefits intended to reduce certain chronic diseases. This US$35 billion market has been steadily growing at 8-14% per year, as estimated by the Food and Agriculture Organization of the United States (FAO). Although the…

Figure 1. On-line biomass monitoring using capacitance is now a routine task in cell culture. The capability to develop advanced bioprocesses relies on sensitive process monitoring technologies and robust process control strategies. Unlike optical technologies, capacitance is insensitive to dead cells, cells debris, gas bubbles, or other matter in suspension. With its capacitance-based sensor, FOGALE nanotech has supplied many pharma/biotech companies around the globe. The Biomass system is widely recognized as a powerful tool from process development to CGMP production…

Biopharmaceutical companies continue to wrestle with how to approach the implementation of process analytical technology (PAT). The accelerated adoption of many new technologies has benefited from the identification of a “killer app,” an early application that enables a readily achieved breakthrough in capability. This can be a totally new capability (e.g., e-mail on the internet) or a major step-change (e.g., 10× or more) in an existing capability. Flashes of inspiration cannot be achieved at will, but we can identify elements…

Figure 1. Manufacture of synthetic peptides ranges from milligram to multikilogram amounts. When a peptide is a biopharmaceutical (API) candidate, the amount required will increase as it moves through clinical trials to marketed product. When developing purification methods, the required “product” API quantity and purity should be considered. Bradykinin is a physiologically and pharmacologically active peptide of the kinin family used in development of antagonists and therapies for hereditary angioedema. Here we describe two different methods of purifying a crude…

Photo 1. Biopharmaceutical processing has been greatly improved over the past 10 years with the introduction of single-use/disposable technology. There has been a landslide of disposable products introduced in the areas of filtration, mixing, sampling, and transferring solutions aseptically. It is common to find papers and studies that detail the efficiencies that disposables offer to the biopharmaceutical market. What about aseptic filling? More importantly, what about the cost of aseptic filling? PDC aseptic Filling Systems offers an answer. The biopharmaceutical…