Search results for " quality"
Article
From Darwin to Recombinant Fc Multimers
… with a QbD approach, delivered a robust process control strategy to deliver a high-level purity and quality recombinant VIIa (rhFVIIa) from a somewhat unusual expression system: milk of transgenic r…
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Advancing Single-Use Technology Through Collaboration
…g from refusal of their market licensure applications to loss of batches due to questionable product quality and even 483 observations. These challenges dampen their enthusiasm and slow down their im…
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Managing Biomanufacturing Capacity Expectations
For example, concentrated fed-batch (CFB) cell culture has been shown in early experiments to yield products of similar quality compared with those made through traditional fed-batch culture (6). Not …
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The methods are well suited for routine use in the quality-control environment and the provided identification approach meets CFR, FDA, and other regulatory agencies requirements. As part of this appr…
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Innovative Therapies Require Modern Manufacturing Systems
…lained, and small biotech companies have run into difficulties with contract manufacturers that have quality and data problems uncovered during plant inspections.
FDA seeks to avoid such issues b…
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Cleaning of Dedicated Equipment: Why Validation is Needed
International Conference on Harmonization (ICH) guidance ICH Q9 (1) encourages that a quality risk management approach be considered and that, based on the level of risk, cleaning processes may be sub…
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What’s In a Name? For Biosimilars, A Lot
…ssion is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. Our flagship compendia of public standards—Un…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Thus, each SUS-manufacturing process needs to be mapped for creation of a tailored manufacturing space that will generate a process where quality (i.e., high cell growth) is designed into the product,…
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Technologies and Practices Must Evolve to Meet Demand
The respondents reported that they were involved in many phases of drug development and manufacturing including process development, drug-substance and finished product manufacturing, quality control,…
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What Drove Biopharma Development in 2014?
One of them is Quality-by Design (QbD). As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that t…