Search results for " equipment" in Articles / App Notes
Article
Remote Monitoring and Big Data Advance Upstream Automation
“Logistical integrations and introduction of benchtop equipment require automation to venture into realms previously untrod,” Navarro observes. “The desire to produce ‘batches of one’ presents very sp…
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Industry Adoption of Single-Use Systems Remains Low
… the need for drug manufacturers to avoid costly investments in traditionally large, stainless steel equipment (1).
Single-use equipment offers the benefit of making…
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Continuous Manufacturing: A Changing Processing Paradigm
Other advantages of continuous manufacturing include consistent product quality; smaller equipment; streamlined processes; low process cycle times; reduced operating costs; increased flexibility; elim…
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PDA's Technical Report for Biotech Cleaning Validation
With the knowledge of large-scale equipment, one can create an approach that results in a successful cleaning validation.
Cleaning validation plays an important role in reducing the possibility of p…
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Reducing Cross-Contamination Risks in Process Chromatography
“When it comes to new facilities, the small footprint and easy-to-use format of the products reduces investment needs with respect to facility, equipment, and labor, enabling cost savings and faster t…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
“Viral-vector manufacturing lends itself to a pre-defined manufacturing process flow and equipment design, which leads to greater uniformity in scale-dependent footprint for multiple processes. Cell t…
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Understanding Validation and Technical Transfer, Part 3
For example, the apheresis unit and operating procedures should be specified based on studies that demonstrate the suitability of the equipment and operating procedures for the intended use. Any clean…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished produ…
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Bioprocessing Advances in Vaccine Manufacture
SUS have moved into large-scale vaccines manufacture more slowly, partly due to the demands for large-scale equipment. In the BioPlan study, vendors were asked if they provide sufficiently scalable si…
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QbD and PAT in Upstream and Downstream Processing
The risk assessment includes a review and assessment of the products CQAs when manufactured on specific equipment.
BioPharm: In implementing QbD, what would you identify as the critical process …