Search results for " methods" in Articles / App Notes
Article
Real Time Continuous Microbiological Monitoring
In addition, traditional methods are unable to sample every particular location and time; these methods provide observations for only a limited time window. Consequently, the microbial monitoring prog…
Article
Process Chromatography Selection for Downstream Processing Applications
In order to address bioburden, one needs good sanitization methods and knowledge about likely species present in the local environment. Techniques such as closed column packing and/or the use of pre-s…
Article
Selecting a Comprehensive Bioburden Reduction Plan
…nitization requirements, establishment of alert/action levels, selection of monitoring and detection methods, operator training requirements, and quality system oversight.
BioPharm: What procedur…
Article
Continuous Manufacturing: A Changing Processing Paradigm
If overall bioprocess yields continue to double every five years, switching from batch bioprocessing to continuous methods may prove even more difficult (1). Making the switch, says Snow, will require…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Materials and Methods
Resins, films, and standards of TBPP used in the study were kindly provided by Renolit, in Enkhuizen, The Netherlands. This included Solmed Infuflex 9101 resin and film (deno…
Article
Improving PAT for Biologics
Advances in high-throughput systems, Raman and near-infrared (NIR) spectroscopy, high-performance single-use sensors, and chemometric methods are also helping manufacturers of biopharmaceuticals overc…
Article
Essentials in Establishing and Using Design Space
Other methods can be used including known scientific equations and regression techniques. DOE is generally the most common approach. DOE helps to generate the equation prior to design-space determinat…
Article
Essentials in Quality Risk Management
As we complete development activities, the risk goes down because our knowledge and understanding of the factors associated with unit operations and analytical methods go up relative to product accept…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
However, for genetic vaccines, this means developing a whole new battery of analytical methods, especially around purity and potency,” Christy states. “Methods exist, but these generally are research-…
Article
Mapping a Route for Cell and Gene Therapy Process Development
These products are highly complex and often involve production methods that, while in some ways are similar to those used in biologics and vaccine manufacturing, in many ways are quite different.
…