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Crystallinity: A Complex Critical Quality Attribute of Amorphous Solid Dispersions
Molecular Pharmaceutics, 2023Does the performance of an amorphous solid dispersion rely on having 100% amorphous content? What specifications are appropriate for crystalline content within an amorphous solid dispersion (ASD) drug product? In this Perspective, the origin and significance of crystallinity within amorphous solid dispersions will be considered.
Dana E. Moseson, Lynne S. Taylor
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Comparability of critical quality attributes for establishing biosimilarity
Statistics in Medicine, 2012To develop a biosimilar product, it is essential to demonstrate the biosimilarity between the proposed biosimilar product and the reference product first in terms of quality in a stepwise approach that can then help inform the extent of safety and efficacy data that will be required to establish biosimilarity.
Liao, Jason J. Z., Darken, Patrick F.
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Analytical Characterisation of Biotherapeutic Process Residuals and Critical Quality Attributes
Downstream processing is an integral part of the manufacturing process of biotherapeutics. The downstream process plays a crucial part in determining the final product purity by removing process impurities, clearing viruses, and ensuring evaluating critical quality attributes are within the defined process specifications.
Buckley, Ciarán
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Manufacturing dexamethasone intravitreal implants: Process control and critical quality attributes
International Journal of Pharmaceutics, 2023Over 20 long-acting injectable formulations based on poly(lactide-co-glycolide) (PLGA) have been approved by the FDA to date. PLGA is a biodegradable polymer that can extend drug release from these dosage forms for up to six months after administration. Despite the commercial success of several of these formulations, there are still a limited number of
Mark A. Costello +8 more
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Glycosylation of Therapeutic Proteins: A Critical Quality Attribute
2021Glycosylation is a common posttranslational modification of therapeutic proteins. The glycosylation pattern is dependent on many parameters such as the host cell line or the culture conditions. N- and O-linked glycans usually play a great role on the stability, safety, and efficacy of the drug. For this reason, glycosylation is considered as a critical
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Exploring the critical quality attributes and models of smart homes
Maturitas, 2015Research on smart homes has significantly increased in recent years owing to their considerably improved affordability and simplicity. However, the challenge is that people have different needs (or attitudes toward smart homes), and provision should be tailored to individuals. A few studies have classified the functions of smart homes.
Luor, T., Lu, H.-P., Yu, H., Lu, Y.
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Biotechnology Journal, 2012
AbstractAdverse immune responses severely hamper the success of biopharmaceutical therapies. Possible clinical consequences include anaphylaxis, reduced drug half‐life and neutralization of the therapeutic protein as well as the endogenous human homologue.
van Beers, Miranda, Bardor, Muriel
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AbstractAdverse immune responses severely hamper the success of biopharmaceutical therapies. Possible clinical consequences include anaphylaxis, reduced drug half‐life and neutralization of the therapeutic protein as well as the endogenous human homologue.
van Beers, Miranda, Bardor, Muriel
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Critical Quality Attributes, Specifications, and Control Strategy
2015In a quality by design (QbD) program, once a process has been characterized and a design space is established, process control of critical quality attributes (CQAs) needs to be assessed and an integrated control strategy , including both process controls and analytical testing (including release limits), needs to be confirmed.
Timothy Schofield +2 more
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A robust dual-mode MPC approach to ensuring critical quality attributes in Quality-by-Design
2016 American Control Conference (ACC), 2016In the Quality-by-Design (QbD) paradigm for pharmaceutical processes, critical quality attributes (CQAs) must meet specifications for all possible realizations of critical process parameters (CPPs) within a design space. During the startup of such a process, it is desired to begin meeting CQA specifications as quickly as possible and then robustly ...
Eranda Harinath +2 more
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Drug Delivery and Translational Research, 2020
Nanomedicine is a rapidly emerging field with several breakthroughs in the therapeutic drug delivery application. The unique properties of the nanoscale delivery systems offer huge advantages to their payload such as solubilization, increased bioavailability, and improved pharmacokinetics with an overall goal of enhanced therapeutic index. Nanomedicine
Maie S, Taha +3 more
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Nanomedicine is a rapidly emerging field with several breakthroughs in the therapeutic drug delivery application. The unique properties of the nanoscale delivery systems offer huge advantages to their payload such as solubilization, increased bioavailability, and improved pharmacokinetics with an overall goal of enhanced therapeutic index. Nanomedicine
Maie S, Taha +3 more
openaire +2 more sources