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 [...]
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 [...]
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. [...]
Nearly every industry in the world has “best practices” that should be followed in order to ensure safety, reliability, efficiency, and compliance. However, in regulated fields such as the production of biologics, these sorts of “best practices” also have more binding cousins called Current Good Manufacturing Practice (cGMP) regulations. These regulations are established and enforced [...]
Cell lines are used in a wide variety of applications, from in vitro trials to vaccine production and from the study of gene function to the manufacture of antibodies and recombinant proteins. Cell lines are cost effective and easy to use when compared to other options. They also allow researchers and CMOs to bypass many [...]
Developers must consider interactions between the formulation, packaging materials and sterilization measures. For liquid formulations that will be introduced directly into body cavities or tissues, or into the bloodstream, sterility is key to the prevention of infection. The need to maintain sterility in both the formulation and delivery system places strict constraints on the selection [...]
Developing a fermentation process for biologics can be daunting – and rewarding. Biologic pharmaceuticals offer vast new avenues for treating an extensive array of diseases and chronic conditions. As the field has advanced, microbial fermentation has grown in prominence as a biologic production method due to its distinct advantages. This technique has even become preferred [...]
Single-use tools may be one of the most effective solutions for avoiding contamination, but they do present several challenges. Contamination can significantly derail the development of a biologic vaccine. When contaminated instruments come into contact with biologic samples, the resulting chemical reactions can ruin the batch by changing the composition of the product, forcing developers [...]
Undaunted by the many challenges posed by biologics processing, developers continue seeking out new techniques. Biopharmaceuticals (or biologics), while not exactly a new technology, are a fascinating and lucrative medical frontier to explore. The first medicine derived from a biological source dates back to the treatment of diphtheria in the 19th century, but the boom [...]
As the complexity of mAbs continues to grow, developers explore the potential of new techniques and expression systems. The development of mAbs (monoclonal antibodies) has come a long way since 1986, when the first mAb, Orthoclone OKT3, received approval for clinical use. Over the past 30 years, mAb production has become streamlined, efficient, and highly [...]
