Search results for " equipment"
Article
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 …
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Technology Innovations Improve Process Chromatography Performance
“It doesn’t help that there’s approximately 30% more effort, such as resources, materials, and equipment, as harvest material goes through downstream purification due to multiple unit operations. Any …
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Supplier-Change Management for Drug-Product Manufacturers
As a result, companies making these products perform extensive studies to validate that the materials, equipment, and processes used for manufacturing consistently produce products that meet specifica…
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Regulatory Challenges in the QbD Paradigm
A QbD inspection would evaluate the overall control strategy, including elements of facility and equipment qualification and maintenance as well as raw material screening and supplier management. Spec…
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Maximum Output Starts with Optimized Upstream Processing
“Vendors have rapidly shifted focus to produce materials to support COVID-19 vaccines and therapies, and as a result some therapeutic developers have had to slow down or redirect demand for equipment,…
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Assessing Manufacturing Process Robustness
…ing quality risk management tools as per ICH Q9
documenting a critical manufacturing equipment suitability assessment
determining degree and understanding variability …
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
…anufacturing batch fluids essentially moving incrementally en-masse from one process step and set of equipment to the next.
Downstream processing continues to create bottlenecks in production,…
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Being Thorough When Transferring Technology
Does the company have the capacity, the equipment, and the capital for the project? If not, is it committed to having a plan in place to meet a client’s timeline while meeting quality and cost expecta…
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Best Practices in Adopting Single-Use Systems
Before long, bioprocessors recognized the value of flexibility, reduced capital costs, and faster campaign turnaround times attainable through disposable bioprocess equipment. Single-use technologies …
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Implementing QbD in Sterile Manufacturing
Equipment Design and Operation
BioPharm: How is equipment design and operation modified when implementing QbD in sterile and aseptic manufacturing?
Weikmann: Looking first at equipme…