Search results for " equipment"
Article
Unifying Continuous Biomanufacturing Operations
In other words, in continuous manufacturing, R&D scale is the same as commercial scale, and a researcher can conduct development studies using commercial equipment (8). Process intensification and the…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
Spending plans for CMOs are positive: almost three-quarters would be increasing their capital equipment budgets, with an average increase of 11.7%.
Expected budget hikes—for capital equipmen…
Article
Technologies and Practices Must Evolve to Meet Demand
Spending on biopharmaceutical manufacturing equipment and services was up compared to 2013; 52.5% reported an increase in spending compared to 2013 (37.8%). The optimistic outlook continues for planne…
Article
Challenges in Analytical Method Development and Validation
Consideration should be given to the availability of required analytical and supporting equipment, software, critical reagents, standards, controls, and analysts who are skilled in the relevant analyt…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the process-qualification stage proceeds, the continuum of criticality was used to develop equipment qualification criteria and strategies for process performance qualification. Finally, in the con…
Article
Digitalization: The Route to Biopharma 4.0
The equipment can be interfaced with the corresponding digital twins using sensors and actuators such that the real time data is fed to the digital twins and the in silico predicted can be employed fo…
Article
Implementing Inline Conditioning to Advance Process Intensification
Our engineering, operations and science departments participated in the equipment design and test together with the Cytiva subject matter experts (SMEs). Our people were able to travel to Sweden for t…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
Single-use bioreactor simplification
What if a single, single-use bioreactor design could be used for both suspension and adherent cell culture? That would help dramatically simplify the equipme…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
… assays—overestimate testing needs!
Methods/equipment qualification: Methodology and equipment/reagents tested for quality control and to minimize contamination risks.
Process quali…
Article
Achieving Process Balance with Perfusion Bioreactors
“Since perfusion processes can run upwards of 60+ days (some even 120+ days), all of the equipment and consumables must be fully reliable, because the biocontainer cannot be changed partway through th…