Search results for "continuous processing"
Article
Digitalization: The Route to Biopharma 4.0
For dynamic inline pH adjustment in continuous processing, model-based control strategy has been employed by predicting the pH profile between the chromatography wash and the elution steps, thereby fa…
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
Technology Innovations Improve Process Chromatography Performance
…aluate whether current process chromatography technologies pose any limits or risks to implementing continuous processing. According to Scanlon, there are definite risks in moving toward continuous b…
Article
Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
…
Article
Moving PAT from Concept to Reality
It also brings incentives to invest in PAT, and advances in sensor technology/connectivity will make continuous processing possible, according Makowiecki.
Intensified processes are much more compl…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
Article
Achieving Process Balance with Perfusion Bioreactors
The benefits of single-use technology align well with continuous processing. “The inherent advantages of single-use systems compared to stainless-steel are speed and flexibility, which are also the ma…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…