Search results for " design"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The purpose of this assessment is to provide a focus for the downstream process characterization work required to complete process validation Stage 1 (process design).
This initial risk assessm…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
In Part I, the author used risk analysis and applied the continuum of criticality to quality attributes during the process design stage of process validation. After using process kno…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed program for COVID-19 vaccine manufacturing, the US governm…
Article
Modular Manufacturing Platforms for Biologics
According to Pär Almhem, president of ModWave, modular design and construction in pharmaceutical process facilities can include either breaking a facility and its manufacturing processes into function…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Each element of the justification needs to be reviewed and evaluated during the cleaning process design stage to defend a lean approach in continuously monitoring the cleaning process. A risk-based ap…
Article
Digitalization: The Route to Biopharma 4.0
…well as reducing the number of experiments that would be required, ensuring process operation in the design space, real-time monitoring, and process diagnosis and prognosis. Implementation of Industr…
Article
Achieving Process Balance with Perfusion Bioreactors
While the implications of media consumption from an economic perspective can be determined at small-scale rather effectively, it is in the scale-up phase where the system design is imperative for real…
Article
Tools for Continuous Bioprocessing Development
These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.
The ability to codify…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
Article
Regulatory Challenges in the QbD Paradigm
Implementation of quality by design (QbD) in this environment has further contributed to the need to clarify what information needs to be included in a regulatory filing and how it should be presented…