Characterization of AAV vectors: A review of analytical techniques and critical quality attributes [PDF]
Molecular Therapy: Methods & Clinical DevelopmentStandardized evaluation of adeno-associated virus (AAV) vector products for biotherapeutic application is essential to ensure the safety and efficacy of gene therapies. This includes analyzing the critical quality attributes of the product. However, many
Theodoros Kontogiannis +6 more
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Critical quality attributes of lipid nanoparticles and in vivo fate [PDF]
Asian Journal of Pharmaceutical SciencesLipid nanoparticles (LNPs) have emerged as versatile carriers for the delivery of genetic medicines and small-molecule drugs, offering desired benefits for therapeutic applications.
Jiaxing Di, Yuhong Xu, Tonglei Li
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Understanding Critical Quality Attributes for Nanocrystals from Preparation to Delivery [PDF]
Molecules, 2015 Poor solubility of active pharmaceutical ingredients (APIs) is a great challenge for the pharmaceutical industry and, hence, drug nanocrystals are widely studied as one solution to overcome these solubility problems.
Leena Peltonen, Clare Strachan
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Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars [PDF]
Pharmaceuticals, 2021 Regulatory approval of biosimilars predominantly relies on biosimilarity assessments of quality attributes (QAs), particularly the potentially critical QAs (pCQAs) that may affect the clinical profile.
Ali M. Alsamil +4 more
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Improving CAR T cell therapy by optimizing critical quality attributes. [PDF]
Semin Hematol, 2020 Whether as a cure or bridge to transplant, chimeric antigen receptor (CAR)-T cell therapies have shown dramatic outcomes for the treatment of hematologic malignancies, and particularly relapsed/refractory B cell leukemia and lymphoma. However, these therapies are not effective for all patients, and are not without toxicities.
Reddy OL, Stroncek DF, Panch SR.
europepmc +5 more sources
Fc glycans of therapeutic antibodies as critical quality attributes. [PDF]
Glycobiology, 2015 Critical quality attributes (CQA) are physical, chemical, biological or microbiological properties or characteristics that must be within an appropriate limit, range or distribution to ensure the desired product quality, safety and efficacy. For monoclonal antibody therapeutics that rely on fraction crystalizable (Fc)-mediated effector function for ...
Reusch D, Tejada ML.
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Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model [PDF]
HeliyonThe management of wounds primarily revolves around pain relief, effective infection control and the promotion of tissue regeneration to prevent complications like chronic skin wounds.
María Florencia Sanchez +3 more
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European Journal of Pharmaceutical Sciences, 2015 Selection of a crystallinity detection tool that is able to predict the critical quality attributes of amorphous formulations is imperative for the development of process control strategies. The main aim of this study was to determine the crystallinity detection tool that best predicts the critical quality attributes (i.e.
Leena Peltonen +2 more
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Mesenchymal Stem/Stromal Cells (MSCs) from Mouse Pelvic vs. Long Bones Exhibit Disparate Critical Quality Attributes: Implications for Translational Studies [PDF]
CellsMesenchymal stem/stromal cells (MSCs) have been exploited as an experimental cell therapy in a broad array of clinical applications but have underperformed based on results from pre-clinical studies due to gaps in translating pre-clinical findings to ...
Siddaraju V. Boregowda +3 more
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Characterization of Critical Quality Attributes of an Anti-PCSK9 Monoclonal Antibody
BiologicsDuring early development of biopharmaceuticals, suboptimal producing clones and production conditions can result in limited quantities of high-purity products.
Thayana A. Cruz +7 more
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