In the last few years, monoclonal antibody (MAb) products have become some of the top-selling drugs in the world. In fact, the biologics market as a whole, which already accounts for more than 20 percent of drug sales worldwide, is growing at a rate of anywhere from 10 to 15 percent per year. This includes [...]
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 [...]
Despite surface similarities, biologics process development and manufacturing sciences are two very different disciplines. They require different sets of skills, draw from varied areas of expertise, and have distinct goals. Yet, when they work in tandem, they can accelerate the timeline for bringing a new biologics product to market. Process development sets forth the parameters [...]
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 [...]
Challenges of adapting vaccines for oral administration remain significant, but emerging techniques promise greater flexibility and efficiency. Pressures to streamline development and production continue to ramp up in many areas of the pharmaceutical industry. This is particularly true in the field of solid oral dosage forms for vaccines, which now account for more than 60 [...]
