Search results for " process" in Articles / App Notes
Article
Use of Multivariate Data Analysis in Bioprocessing
Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motivated biotech manufacturers to focus on process opti…
Article
Remote Monitoring and Big Data Advance Upstream Automation
Challener
As upstream processing drives toward higher efficiencies in meeting demand, it requires optimizing the current state of manufacturing with the goal of achieving real-time release and an …
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
While this approach sounds like a practical approach to accelerating vaccine manufacturing, rapid changeover of biologic production process carries numerous challenges. There are a few different strat…
Article
Understanding Validation and Technical Transfer, Part 2
While the example is not related to biopharmaceutical manufacture, it demonstrates various points to consider related to the inputs, the processing system, and the outputs that can be applied to bioph…
Article
Unifying Continuous Biomanufacturing Operations
The most efficient upstream processing systems in biologics manufacturing seek to mimic the body’s treatment of cells, so a constant level of incoming nutrients and outgoing waste products is necessar…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Mid-phase assessment includes further characterization of the integrity and stability of the integrated transgenes using the defined commercial cell-culture processes. Finally, the presented strategy …
Article
Modular Manufacturing Platforms for Biologics
… building modules with utility systems (such as from Pharmadule/Morimatsu); or building modules with process systems (such as Cytiva’s KUBio FlexFactory platform). According to Pär Almhem, president …
Article
Scaling Up Novel Therapies
They also allow manufacturers to leverage performance data across multiple products, reducing the cost of late-stage process characterization and qualification. In addition, they permit some degree of…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…accines, recombinant proteins, and monoclonal antibodies, is associated with the concomitant risk of process/product contamination with endogenous retroviruses, latent viruses, or new and emerging ad…
Article
PDA's Technical Report for Biotech Cleaning Validation
49: Points to Consider for Biotechnology Cleaning Validation, well–designed laboratory-scale studies can be performed using design of experiments, and the data analyzed to understand the cleaning proc…