Search results for " knowledge"
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
In contrast to this approach, a second product with a different client was planned and scheduled against a timeline with a built-in strategy to gain knowledge of the process more quickly. The predicte…
Article
Nurturing Knowledge from Disparate Data Streams
Scientists in the laboratory should have knowledge in their fields of expertise and not need to be experts in software applications as well,” she adds.
Throughout pharma discovery, development…
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Quality by design for biotechnology products—part 1
The QbD approach can be maintained throughout the lifecycle of the product to facilitate innovation and continuous improvement based on expanded knowledge and new technologies. This knowledge is gaine…
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Regulatory Challenges in the QbD Paradigm
Under this paradigm, manufacturers have extensive knowledge about product, process, and quality attributes and strive for continuous improvement to reach the desired end point of consistent, safe and …
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This article presents the first part of a practical roadmap that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process valid…
Article
Essentials in Establishing and Using Design Space
Knowledge about how X factors influence Y responses relative to CQAs is fundamental to defining and defending that knowledge. Ultimately, knowledge must be in the form of an equation (either empirical…
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Addressing the Complex Nature of Downstream Processing with QbD
The International Council for Harmonization (ICH) defines QbD as a systematic approach that incorporates prior knowledge, results of studies using design of experiments (DoE), use of quality risk mana…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
After using process knowledge to relate the attributes to each process unit operation, the inputs and outputs of each unit operation were defined to determine process parameters and in-process control…
Article
Digitalization: The Route to Biopharma 4.0
Digitalization in process development
For any production process, there are two key attributes, namely scientific knowledge and technical know-how. Scientific knowledge comprises process developme…
Article
Remote Monitoring and Big Data Advance Upstream Automation
…his scale is typically the realm of data engineers and data scientists, who may have limited process knowledge. There is a need for chemometricians not only skilled at pre-processing of spectra, but …