1408, 2019

Key Considerations For Current Good Manufacturing Practices (cGMP) in Biologics

By |August 14th, 2019|Categories: Research & Development|0 Comments

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 [...]

2907, 2019

The Importance of Optimal Cell Line Development

By |July 29th, 2019|Categories: Research & Development|0 Comments

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 [...]

2707, 2019

How Biologics Process Development and Manufacturing Work Hand-In-Hand to Accelerate Delivery

By |July 27th, 2019|Categories: Manufacturing|0 Comments

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 [...]

811, 2018

Sterile Formulation Development Faces Challenges in Blow-Fill-Seal Systems

By |November 8th, 2018|Categories: Research & Development|0 Comments

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 [...]

810, 2018

Meeting Challenges in Biologic Fermentation Development

By |October 8th, 2018|Categories: Research & Development|0 Comments

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 [...]

710, 2018

How Single-Use Instruments are Revolutionizing Biologic Vaccine Development

By |October 7th, 2018|Categories: Research & Development, Uncategorized|0 Comments

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 [...]