Search results for " equipment"
Article
Defining Risk Assessment of Aseptic Processes
This is why so much attention is given to monitoring personnel, equipment, air quality, etc., for microbial organisms and identifying and trending what those organisms are and where they are coming fr…
Poster
Improve operational efficiency in biomanufacturing with comprehensive automation solutions
However, equipment used are often connected only by process; that is, the bioprocess material passing between each of them. Often this connection is discontinuous, meaning equipment is controlled on a…
Article
Platform Approach Speeds Process Development
Global site-to-site transfers in the same company or to external partners can be challenging when different equipment with different geometries are used. Identical disposable bioreactors can be used a…
Article
Lessons Learned Accelerate Vaccine Development
The production and development teams worked very closely together, and there was also extensive collaboration with external partners, including raw material and equipment suppliers, contract partner I…
Article
Tools for Continuous Bioprocessing Development
• Equipment is being miniaturized for controlling DO and pH (9, 10) by integrating optical pH and DO sensors with 24-well plates and sparging oxygen and carbon dioxide through a permeable membrane at …
Article
Biopharma in 2015: A Year for Approvals and Innovations
A paper on process economic comparison between fermentation in single-use versus stainless steel equipment on PDF was well received.
This year, PDF will continue to report on drug approvals, innova…
Article
Best Practices in Qualification of Single-Use Systems
Technical Considerations: Chemical Compatibility
Unlike traditional stainless-steel equipment, SUS is generally made from polymers including plastics and elastomers. These polymers are obtained th…
Article
Biopharma Advances Demand Specialized Expertise
Lively (PPD): Evolving characterization expectations for biologics have driven improvements in analytical equipment, processes, and systems. Ultra performance liquid chromatography (UPLC) systems have…
Article
Ensuring the Quality of Biologicals
These general chapters give requirements for equipment and equipment verification and instructions on how to perform a method, such as peptide mapping. Ph. Eur. monographs and general chapters for bio…
Article
Improving PAT for Biologics
…ty of raw materials (particularly living organisms), and the move from stainless-steel to single-use equipment. The recent emphasis on establishing a thorough understanding of the manufacturing proce…