Agreed standards will drive all industry players towards the same goal: better bioprocessing. And efforts from BPOG, among others, are leading the way.
Develop efficient and robust processes by using Design of Experiments, a method that can uncover complex relationships while saving resources.
A growing number of biologic manufacturers are adopting new fill-finish technologies, including single-use systems, pre-filled syringes, and automated fill-finish systems. When doing so it is critical to also consider the cost-benefit tradeoffs.
Demand to increase speed and flexibility while maintaining sterility spurs the adoption of novel technologies and materials, all of which introduce new challenges.
Developing a biologic product is a high-risk enterprise, with possible delays and disruptions potentially costing months of work and millions of dollars. This article provides an in-depth analysis of some of the most common causes of delays, disruptions and audits, along with measures some biologic manufacturers are taking to offset these challenges.
To help meet the needs of both large- and small-scale operations, suppliers of sterilizing-grade filters have developed new products and technologies to help meet the needs of today’s biomanufacturing processes. Industry trends toward intensified processing and increased implementation of single-use systems are changing approaches to sterile filtration and bioburden control in biomanufacturing processes.
Airflow visualization testing, conducted as part of a routine review program, can help assure that aseptic filling areas remain under a state of proper control.
Sterile filtration of liquids is vital to minimizing microbial contamination and ensuring product safety and integrity. Understanding the criteria for optimum filtering helps streamline product selection.
An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.
Selecting the right filter is the first step in reaping the benefits of today’s filters; optimizing their performance efficiency is key to maximizing the benefits for the lifetime of your process.
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