Using scale-up strategies that consider certain challenges, in combination with truly scalable bioreactor equipment can offer efficient approaches to scaling-up bioprocesses from early development to final production.
To drive appropriate and dependable critical process control requirements, Biogen explored several novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.
What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
There are a number of factors to be taken into consideration when selecting containers for use within a critical environment.
How the industry changed, and how a packaging technology has adapted to the new business environment.
Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.
What businesses need to know about change management when it comes to adopting new technologies in their labs, and how can lab managers introduce new technologies without ‘rocking the boat’ too much.
Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits.
Companies are increasingly looking towards more holistic solutions, as they realize that all data is part of the same, bigger picture. For R&D organizations, data is the new gold.
|
|
|
|
|
|
|
|
|