Search results for " Lifecycle"
Article
Avoiding Investigational Failures and Discrepancies
…ory for all documents pertaining to investigations
Connections to all departments, product lifecycles, and quality processes
Reduces duplicated efforts and data entry errors
…
Article
Process Chromatography: Continuous Optimization
…ust also consider the potential to increase the column capacity, binding/ separation capacity, resin lifecycle, and/or column cleaning efficiency, according to Deorkar. “In addition to these opportun…
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The New World of Biopharmaceutical Manufacturing
That might imply driving toward standardization from different perspectives: designs, interconnectivity, technical qualification packages, certificates, manufacturing practices, and product lifecycle …
Article
Being Thorough When Transferring Technology
Blackwell (Windshire): Lifecycle document and knowledge management is crucial due to the complexity of biologics. Procedures that govern technical documentation requirements gated to each stage of dev…
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Drug Quality Key to Innovation and Access
An important new quality guideline on lifecycle management of pharmaceuticals (Q12) is moving forward slowly, and should complement the series of ICH quality standards developed to encourage manufactu…
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Biosimilars to Drive Modern Manufacturing Approaches
Manufacturing systems for any biological product normally entail multiple revisions and improvements throughout the product lifecycle, and biosimilars are expected to follow this pattern. The regulato…
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Improving Process-Scale Chromatography
Cytiva conducted several lifecycle assessments (LCAs) for complete mAb production processes, upstream to downstream, comparing single-use stainless-steel approaches.
LCAs provide a holistic perspe…
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Establishing Acceptance Criteria for Analytical Methods
3]
Knowing what is the allowable contribution of the method error in drug performance becomes crucial when building product knowledge, process understanding, and the associated long-term product l…
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Biopharma Advances Demand Specialized Expertise
…esses?
Hartzel (Catalent Pharma Solutions): Today there is a stronger emphasis in the development lifecycle on the delivery of the molecule to the patient and not just the molecule itself. Deliver…
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Use of Multivariate Data Analysis in Bioprocessing
The authors in that study presented a methodology with the aid of chemometric tools to predict column underperformance at the manufacturing scale over product lifecycle. This approach allows the opera…