Biosimilar Manufacturing solution center
Using QbD Principles To Register Innovative Raw Materials
Control of biopharmaceutical raw materials is defined by the license holder. We propose a best practice approach to registering innovative and complex raw materials based on quality by design (QbD) principles. It can be applied to different families of non-compendial raw materials used when manufacturing biologics.
A Guide To Polishing Chromatography In Process Development
Polishing chromatography describes the removal of minute amounts of impurities in the final phase of biopharmaceutical manufacturing. Explore considerations in developing your polishing steps.
Using Mathematical Models To Improve Process Development
Explore the differences between statistical and mechanistic models along with their use in improving process development.
After Decades Of Biomanufacturing Workforce Development, What’s Next?
We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.
4 Focus Areas To Modernize Your Cleaning Validation Strategy
The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.
Process Control And Performance Of A Depth Filtration System
Explore a demonstration of strategic process control in terms of flow and pressure, by utilizing a depth filtration system, for effective depth filter processing and recovery of excess product.
How Distributed Automation And DPM Support Resilient Biomanufacturing
Embracing digital transformation, when combined with biomanufacturing best practices, supports increased productivity and efficiency in a biomanufacturing environment. Learn how distributed automation and digital plant maturity support resilient biomanufacturing.
Considerations For Microbial Enumeration Methods When Working With CDMOs
In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.
rAAV Production Using HEK293 Cell Line And Transfection Medium
Learn more about improving the performance of a scalable AAV process in Xcellerex™ XDR-10 and XDR-200 bioreactors using HyClone™ peak expression medium.
Considerations For Sterility Test Methods When Working With CDMOs
Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.