Search results for "continuous" in Articles / App Notes
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
For example, FDA has been an active proponent of continuous manufacturing for small-molecule drugs. Now that several drugs manufactured via continuous processing have been approved, the interest in th…
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The New World of Biopharmaceutical Manufacturing
We must drive continuous improvement in education, standardization, and technology. Industry stakeholders (e.g., suppliers, users, regulators) must continue to exchange expertise and knowledge. Collab…
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Can you talk to us about the state of continuous processing in biotechnology?
A: Yes, the event is the International Symposium on Continuous Manufacturing of Pharmaceuticals (May 20-21, 2014…
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Assessing Manufacturing Process Robustness
…gram, in cases where product has been determined to be robust,
Developing a Stage 1 continuous improvement plan, or
Developing a Stage 1 remediation plan.
…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The increasing popularity of single-use bioreactor systems and continuous processing techniques have brought both new opportunities and challenges to upstream bioprocessing. Together, these trends hav…
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Moving PAT from Concept to Reality
PAT is not only enabling, but essential, to continuous bioprocessing. With sufficient advances, emerging PAT solutions should ultimately make real-time release testing possible.
In-line, at-line, …
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Modular Manufacturing Platforms for Biologics
…ations within modules, such as suites made exclusively for aseptic filling of prefilled syringes or continuous manufacturing lines (1). Prefabricated fill line/cleanroom unit combinations via pods—or…
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Reducing Cross-Contamination Risks in Process Chromatography
A continuous dynamic
Continuous processing has the overall advantage of maximizing production efficiency while minimizing capital expenditures and equipment downtime, according to Morelli, whi…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The actual number of samples required varies based on the data type (discrete or continuous) and the expected distribution (normal or unknown). The samples are assessed by individual lot, or if no sig…
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Supply Chain Challenges for Single-Use Systems
…ntinuity planning, change control management, disaster recovery planning, supply-chain mapping, and continuous improvement. At MilliporeSigma, a cross-functional team of subject matter experts assess…