Search results for " equipment" in Articles / App Notes
Article
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…
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Tools and Processes for Mature and Emerging Therapies
In April 2019, at the INTERPHEX trade show in New York City, vendors of bioprocessing equipment and materials announced improvements to existing platforms, added options for upstream and downstream sy…