Search results for "quality" in Articles / App Notes
Article
Driving Improved Access to Biosimilars
The agency also published draft guidance on the analytical methods to be used to establish biosimilar comparability and quality (12). According to reports on May 13 and May 21 in the Regulatory Affair…
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Automating the Biomanufacturing Process
Control has been manifested mainly in minimizing manual interactions and preventing operator error, to prevent variability in production and in product quality that would require correction.
Today…
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The Challenge of Disruptive Technologies in Bioprocessing
…very, supply chain logistics, full [good manufacturing practice] GMP documentation, high consistent quality, and easy customer relations,” she asserts.
Disruptive innovations
“Keeping in mind…
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Biopharma Seeks Balance
Peters
A biopharma company answers to multiple masters: the patient who depends on effective drug products for health or survival; regulatory authorities that monitor 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…