Search results for " equipment"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Two otherwise identically configured runs may produce slightly different responses due to changes in environment, equipment, measurement, sampling, and operators, among others. Even deliberately fixed…
Article
The Lifecycle Change of Process Validation and Analytical Testing
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APPLYING PAT
BioPharm: How may a given manufacturing process (including equipment design and operation) and analytical testing need to be modified to accommodate this lifecycle app…
Article
Discovering the unknown: How does in silico process development change PD scientists’ work?
In general, having a mechanistic model in place that can be used to run in silico predictions anytime, anywhere without the need of lab equipment is a big advantage and proved especially valuable duri…
Article
Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems
In a validated GMP process, filters must be routinely tested for integrity. The automated test instruments that are used for filter integrity testing have been improved over the past 40 years. …
Article
Current Techniques and Challenges Presented in Scaling Between Bioreactors
On the other hand, it is also important to know the equipment with the mass transfer characteristics. The tech transfer and bioreactor scaling are tasks that require versatile skill set in the team.
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Article
New hydrophobic interaction chromatography (HIC) handbook
The role of this technique in protein purification in the lab and at bioprocess scale, the principle of the technique, and the equipment and resins needed are described in this detailed handbook.
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Article
Principles of Cell Line Development
It also takes a closer look at where it fits into this wider process including:
Overall path to market
Key processes and methods
Tools and equipment
Key regulatory re…
Article
Moving beyond automation - next industrial revolution is digital
Connected machines and software systems can enhance the human workforce, minimize maintenance downtime and spare part inventory for process equipment with the aim to improve process robustness and eff…
Article
Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
…3:44 – Technologies that contribute to accelerated process development
6:36 – The role of equipment and material suppliers in expediting process development
9:40 – The industry’s adopti…
Article
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…