Systematic assessment of process analytical technologies for biologics
In order to evaluate the application of PAT tools to the development and commercialization of a bioprocess, BioPhorum conducted a benchmarking survey of biopharmaceutical companies and published the results in Biotechnology and Bioengineering journal. The study is considered the first of its kind in which investigators assessed fifteen companies receiving seventeen responses from them and evaluated more than 20 different types of PAT tools in manufacturing using an industry-wide assessment to identify and rank the tools based on technological attributes such as technology maturity, ability to enable process control, and ease of implementation, as well as their business value such as simplicity of implementation, lead time, and cost reduction. Upstream and downstream unit operations were evaluated under r the development and manufacturing space. Assessment was done ‘in-line’ where samples are measured within the process stream, ‘on-line’ where samples are diverted automatically for analysis and ‘at-line’ which includes removal of samples from the process stream.