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 ra…
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Advancing Single-Use Technology Through Collaboration
… 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 imp…
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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
At the same time, though, the development of such innovative and targeted therapies heightens the importance of establishing production systems and processes capable of fast scale-up of high-quality c…
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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
…sion 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—Uni…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The present case study shows that film-manufacturing parameters can be controlled to manufacture, from a cell-culture perspective, high-quality and low-quality films.
Materials and Methods
Res…
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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…