Vaccines are among biotechnological products characterized by continuous growth over the past decade. According to a 2011 report, the global vaccine market is expected to reach US$34 billion in sales by 2013 (1). Much development can be ascribed to vaccine treatments for cancer, autoimmune, and infectious diseases (which have risen significantly) as well as the growing worldwide population and emergence of new pandemics. Although to date the main health impact of vaccines is still in disease prevention, the…
MAb
Reducing the Environmental Impact of Single-Use Systems
Committed to sustainability, EMD Millipore is working to provide solutions for the life sciences industry. This commitment is driven by four global issues: climate protection, global health, clean water, and resource efficiency. The company is designing product and process improvements to address these challenges and meet customer expectations. Figure 1: () Life-cycle assessment (LCA) is one of the most rigorous tools we use to help us understand and quantify our products’ environmental impacts (Figure 1). This holistic,…
Revisiting Protein A Chromatography
Due to the molecular complexity of monoclonal antibodies (MAbs) and potential impurities in cell culture media before purification (host-cell proteins, DNA, media components) (1), subsequent downstream operations must consistently and reproducibly purify products to ensure safety and efficacy. The latest member of GE Healthcare’s MabSelect family is called MabSelect SuRe LX (2). As Table 1 shows, it has been developed using the same highly cross-linked agarose base matrix and protein A ligand as for other MAb affinity resins (Table 1).…
Production of CGMP-Grade Lentiviral Vectors
Lentiviral vectors are important tools for gene transfer because of their ability to transduce a number of cell types without the need for host cells to be dividing (1, 2). As a result, investigators are using them as gene delivery vehicles in clinical applications (3,4,5,6). Although these vectors are used routinely in many research laboratories, large-scale production using current good manufacturing practice (CGMP) methods comes with a set of challenges that must be considered as more clinical trials using lentiviral…
Production and Purification of a PER.C6-Expressed IgM Antibody Therapeutic
Immunoglobulin G (IgG) antibodies have been used to treat cancer for many years (1). Another class of antibodies—immunoglobulin M (IgM)—has been overlooked in spite of offering unique advantages that make them highly desirable as cancer therapeutics. Serving a valuable function in our innate immune system, IgM antibodies are the first to be secreted when an abnormal cell is present (2). These antibodies play a critical role in recognition and elimination of infectious particles (3,4), in removal of intracellular…
Sustainability in Bioprocessing
The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines…
Monoclonal Antibody Manufacturing
Continuing the theme of this occasional series, we examine the role of manufacturing in the supply chain in terms of what is required to deliver affordable medicines to patients. The industry has debated the relevance of manufacturing costs in the overall big picture (1). Rising manufacturing costs as a proportion of the overall selling price coupled with increased competitive pressures creates a strong drive to reduce manufacturing costs. However, cost of goods (CoG) is not the only strategic…
Use of Blast Freezers in Vaccine Manufacture
Vaccines are powerful and cost effective prophylactic tools for protecting public health. The Global Alliance for Vaccines and Immunizations (GAVI) estimates that ~5.4 million lives are saved each year by the administration of vaccines for hepatitis B, measles, haemophilus influenza type B (hib), pertussis (whooping cough), yellow fever, and polio (1). According to the World Health Organization, seasonal influenza alone claims 250,000–500,000 lives every year globally, many of which could be prevented by more widespread vaccination with the…
Evaluating Disposable Depth Filtration Platforms for MAb Harvest Clarification
At small to medium scales, single-use technology offers significant advantages over traditional reusable (e.g., stainless steel) manufacturing technology with regard to flexibility, cost of goods, implementation timelines, and maintenance. However, process design based on disposables does create new challenges. With traditional fed-batch processes, harvest clarification is usually achieved by centrifugation followed by depth filtration. For processes based entirely on disposables, the disc-stack centrifuge needs to be replaced by filtration alone. To extend its manufacturing capabilities and capacities, Rentschler decided to…
DNA Vaccine Technology
Picture rows and rows of chicken eggs incubating not to hatch chickens, but to produce vaccines. With the exception of a few products on the market now, most vaccines are still made using this 50-year-old technology. Using chicken eggs to produce vaccines takes about half a year to complete and requires on average one to two eggs to make a single vaccine dose. It is inefficient, labor intensive, time consuming, and subject to contamination. The latter may be…