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Use Advanced Analytics To Usher In The Continuous Manufacturing Era

Regulatory support and innovations in technology have fueled the adoption of continuous manufacturing in pharma over the last several years, which exhibits a move toward operations excellence marked by rapid production within multi-use facilities, reduced scale-up risk, and greater quality expectations. The end-to-end, integrated, and intensified processing approach to drug production offers a wide range of benefits that help drive the industry’s goals to increase efficiency in drug development and manufacturing while lowering costs. 

The Human Side Of Pharma 4.0

With patient health and safety on the line, it is not uncommon for any promising technology or solution aimed at delivering added efficiency and safety to drug development and manufacturing to gain the attention of pharma’s subject matter experts (SMEs). Intellectual analysis combined with justified skepticism help vet each one to determine how far these movements and their buzzwords make it into our strategies as well as our lexicon.

Developing Process Control Strategies for Continuous Bioprocesses

Process control enables biomanufacturers to ensure that operating parameters are within defined specifications. A control strategy should be established during early stages of process development while process and product performance are being defined using risk-based methods such as quality by design (QbD) and process analytical technologies (PATs).