The Importance of Optimal Cell Line Development
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 [...]
How Biologics Process Development and Manufacturing Work Hand-In-Hand to Accelerate Delivery
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 [...]
Sterile Formulation Development Faces Challenges in Blow-Fill-Seal Systems
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 [...]
Meeting Challenges in Biologic Fermentation Development
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 [...]
How Single-Use Instruments are Revolutionizing Biologic Vaccine Development
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 [...]
Key Concerns in Microbial Biologic Development
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 [...]