Viruses are appealing vectors for gene delivery because they have evolved over time to deliver nucleic acid directly to specific cells. The same traits that make viruses difficult to treat—their efficiency at targeting particular cells and their ability to avoid immunosurveillance—make them excellent candidates for gene delivery in both research and clinical settings. However, the [...]
Many people who work in the field of aseptic manufacturing may never have heard of aseptic non-touch technique (ANTT). That’s because it was actually pioneered in nursing, where many aseptic techniques “evolved more from anecdotal evidence and ritualistic practice than from empirical research,” according to an article published in the Nursing Times. In an effort [...]
The time, equipment, training, and cost required to create compliant parenteral products make outsourcing to parenteral contract manufacturers an attractive option for pharmaceutical companies. Because parenteral drugs bypass the body’s natural defenses, they must be totally sterile upon delivery, which means they must be sterilized completely during manufacture or processed aseptically from beginning to end. [...]
Viral vectors are at the cutting edge of gene therapy, cancer treatment, and vaccine development, but which vector is right for which therapy depends on a great number of factors. Advancements in the last few decades have led to much wider use of viral vectors in gene therapy, vaccines, and oncolytic therapies. As vaccines, they [...]
Right now, pre-filled syringes are one of the most popular forms of delivery for countless parenteral products, both under hospital conditions and at home. What’s more, their popularity has grown exponentially in recent years, and shows no sign of slowing in the coming decades. However, the ubiquity of parenteral products delivered via pre-filled syringes brings [...]
Aseptic processing is used in many industries, for many purposes besides the production of sterile drug product. For example, aseptic processing has become the industry standard for handling liquid food products such as milk, fruit juice, and others—not to mention growing in popularity for foods like cottage cheese, vegetable soups, and baby food, to name [...]
E. coli expression systems involve many variables but are one of the most common and efficient methods for protein expression. E. coli is by far the most popular protein expression platform. The days when pharmaceutical manufacturers had to refine large quantities of plant or animal tissues and fluids into the desired protein are practically gone. [...]
The lyophilization cycle is a key component in the manufacturing process of many pharmaceutical products. Understanding lyophilization requires a basic understanding of sublimation—the process by which a solid transitions directly to a vapor or gaseous state without first passing through a liquid phase. Sublimation is part of the lyophilization cycle, during which ice or other [...]
Clinical trials are an integral part of the drug development process, but successful clinical trials require materials that can be quickly and reliably produced in accordance with the dynamic demands of trial protocols. The manufacture of clinical trial material (CTM) often happens at smaller scale than other contract manufacturing operations, and may come with highly [...]
Monoclonal antibody production is expensive and complex but produces highly specific antibodies which can target antigens extremely effectively. Antibodies attach to antigens at the antigens’ epitopes. The specificity of an antibody’s variable region is what determines its affinity for the epitope. Some antigens may be so chemically similar, however, that antibodies raised against one antigen [...]
