Suchergebnisse - "Critical Quality Attributes"

Advanced characterization of alpha-galactosidase nanoliposomal formulations for Fabry disease treatment

Autoren: Carreño Fibla, Aida

Thesis Advisors: Ventosa, Nora, Corchero Nieto, José Luis, González Mira, Elisabet

Quelle: TDX (Tesis Doctorals en Xarxa)

Schlagwörter: Nanoliposomes, Nanoliposomas, Alfa-galactosidasa, Alpha-galactosidase, Atributs crítics de qualitat, Critical quality attributes, Atributos críticos de calidad, Ciències Experimentals

Dateibeschreibung: application/pdf

Zugangs-URL: http://hdl.handle.net/10803/691602

Stability and bioequivalence challenges in generic drug formulation: A regulatory perspective

Autoren: DuPont, Maria Elise

Quelle: GSC Biological and Pharmaceutical Sciences. 31:166-178

Schlagwörter: Bio Equi valance (BE), CHMP (Committee For Medicinal Products For Human Use), Stability Testing, Federal Drug Administration (FDA), Prequalification of Medicines Programme (PQP), Chas (Critical Quality Attributes), Abbreviated New Drug Application (ANDA)

Application of the Quality-by-Design Approach at the Laboratory Stage of Tablet Development

Autoren: M. V. Karlina V. M. Kosman M. N. Makarova et al.

Quelle: Регуляторные исследования и экспертиза лекарственных средств, Vol 15, Iss 2, Pp 168-178 (2025)

Schlagwörter: quality target product profile, Medicine (General), R5-920, quality by design, laboratory stage, critical material parameters, dosage form, tablets, critical process parameters, critical quality attributes, production, pharmaceutical development

Zugangs-URL: https://doaj.org/article/65c3e1696d494654a8e4410181eaa6a4

Quality by Design-Guided Development of Hydrogel-Forming Microneedles for Transdermal Delivery of Enfuvirtide

Autoren: Huanhuan Li Lalitkumar K. Vora Qonita Anjani et al.

Quelle: ACS Appl Mater Interfaces
Li, H, Vora, L K, Anjani, Q, Abraham, A M, Cong, Y, Moreno-Castellanos, N, Ballana, E, Muñoz, E R, Nevot, M & Donnelly, R F 2025, 'Quality by design-guided development of hydrogel-forming microneedles for transdermal delivery of enfuvirtide', ACS Applied Materials & Interfaces, vol. 17, no. 18, pp. 26227-26251. https://doi.org/10.1021/acsami.5c00499

Schlagwörter: enfuvirtide, quality by design, design of experiment, Hydrogels, Enfuvirtide, Administration, Cutaneous, transdermal drug delivery, Drug Delivery Systems, Needles, critical process parameters, hydrogel-forming microneedles, Animals, critical quality attributes, critical material attributes

Dateibeschreibung: application/pdf

Zugangs-URL: https://pubmed.ncbi.nlm.nih.gov/40063825
https://pure.qub.ac.uk/en/publications/8d0099db-4627-44b9-bd13-6fbb89f6c121

When conventional approach in toxicity assays falls short for nanomedicines: a case study with nanoemulsions

Autoren: Ines Nikolić Jelena Đoković Dora Mehn et al.

Quelle: Drug Deliv Transl Res
Drug Delivery and Translational Research

Schlagwörter: Nanoemulsions, PEGylation, In vitro cytotoxicity, Critical quality attributes, Original Article, Orthogonal techniques, Nanomedicines

Zugangs-URL: https://farfar.pharmacy.bg.ac.rs/handle/123456789/5902

End-to-end dataflow engineering framework of honey manufacturing from intermediates to process by TAS1R2@AuNPs/SPCE biosensor coupled with quality transfer principle

Autoren: Xiaoyan Hu Jingqi Zeng Lijuan Ma et al.

Quelle: Fundam Res
Fundamental Research, Vol 5, Iss 1, Pp 407-418 (2025)

Schlagwörter: Q1-390, Science (General), End-to-end dataflow, Critical quality attributes, 02 engineering and technology, Honey manufacturing, Quality transfer principle, 0210 nano-technology, 01 natural sciences, Biosensor, Article, 0104 chemical sciences

Zugangs-URL: https://pubmed.ncbi.nlm.nih.gov/40166091
https://doaj.org/article/a1dc7692b2b746918f562d058a1d5460

Quality by Design (QBD) in Pharmaceutical Development: A Review of Principles and Case Studies

Autoren: Vasave, B. Lucky Bhamare, S. Mayur Bachhav, L. Rushikesh et al.

Quelle: 17(3):203-211

Exploring the challenges faced by generic version of complex drugs: a scoping review

Autoren: Amatha Sreedevi Elstin Anbu Raj D. Sreedhar et al.

Quelle: Systematic Reviews, Vol 14, Iss 1, Pp 1-19 (2025)

Schlagwörter: Complex generics, Hybrid drugs, Critical quality attributes, Quality and safety, Hurdles, Medicine

Dateibeschreibung: electronic resource

Relation: https://doaj.org/toc/2046-4053

Zugangs-URL: https://doaj.org/article/69c4092f12574f2d91c9723b5cf2531b

ROLE OF QUALITY BY DESIGN (QBD) IN ENHANCING THE ROBUSTNESS OF SOLID ORAL DOSAGE FORMS

Autoren: Dr. Deepak Shrivastava

Schlagwörter: Process Analytical Technology, Solid Oral Dosage Forms, Quality by Design, Robustness, QbD, Design Space, Critical Quality Attributes

Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs

Autoren: Herbst, Laura Nießing, Bastian Schmitt, Robert H.

Quelle: Frontiers in Bioengineering and Biotechnology. 13

Schlagwörter: Quality-by-design, Bioreactor, Critical quality attributes, Mesenchymal stem cells, Critical process parameter, Standardization

Online native hydrophobic interaction chromatography-mass spectrometry of antibody-drug conjugates

Autoren: Trevor Kempen Lance Cadang Yuchen Fan et al.

Quelle: mAbs, Vol 17, Iss 1 (2025)

Schlagwörter: Antibody-drug conjugates, critical quality attributes, drug-to-antibody ratio, hydrophobic interaction chromatography, multi-dimensional liquid chromatography, native mass spectrometry, Therapeutics. Pharmacology, RM1-950, Immunologic diseases. Allergy, RC581-607

Dateibeschreibung: electronic resource

Relation: https://doaj.org/toc/1942-0862; https://doaj.org/toc/1942-0870

Zugangs-URL: https://doaj.org/article/0c952b2ce8c440ca9f2e6ab755ec73e9

Analytical methods for in-depth characterisation of cell culture bioreactors: A case study

Autoren: Janik D. Seidel Clifford Young Manuela Klingler-Hoffmann et al.

Quelle: Journal of Chromatography Open, Vol 8, Iss , Pp 100248- (2025)

Schlagwörter: Host cell proteins, Amino acids, Mass spectrometry, High performance liquid chromatography, Bioreactors, Critical quality attributes, Analytical chemistry, QD71-142

Dateibeschreibung: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2772391725000465; https://doaj.org/toc/2772-3917

Zugangs-URL: https://doaj.org/article/75b82a3a2ecc4628a34b9918e1f6edff

The potential of microfluidic cell analysis in CAR T cell therapy manufacturing

Autoren: Aleksandra Nikoniuk Koki Lilova Michael Thomas et al.

Quelle: Frontiers in Bioengineering and Biotechnology, Vol 13 (2025)

Schlagwörter: cell therapy manufacturing, microfluidics, critical quality attributes, quality control, CAR T cell, process analytical technologies (PAT), Biotechnology, TP248.13-248.65

Dateibeschreibung: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fbioe.2025.1613836/full; https://doaj.org/toc/2296-4185

Zugangs-URL: https://doaj.org/article/f5fa4bb629f1422180da7324e33ceb67

Optimizing viral transduction in immune cell therapy manufacturing: key process design considerations

Autoren: Liu Dan Lee Kang-Zheng

Quelle: Journal of Translational Medicine, Vol 23, Iss 1, Pp 1-17 (2025)

Schlagwörter: Viral transduction, Cell therapy manufacturing, Critical process parameters (CPPs), Critical quality attributes (CQAs), Immune cell therapy, Medicine

Dateibeschreibung: electronic resource

Relation: https://doaj.org/toc/1479-5876

Zugangs-URL: https://doaj.org/article/3d1490317af6426aac2de856c7e542af

Characterization of Critical Quality Attributes of an Anti-PCSK9 Monoclonal Antibody

Autoren: Thayana A. Cruz Nicholas R. Larson Yangjie Wei et al.

Quelle: Biologics, Vol 4, Iss 3, Pp 294-313 (2024)

Schlagwörter: Repatha, evolocumab, mAb characterization, QH301-705.5, anti-PCSK9 monoclonal antibody, critical quality attributes (CQAs), Biology (General)

Zugangs-URL: https://doaj.org/article/4ce9af17cf744b2d9eec9bbc902b6693

Process Validation of Sitagliptin Film Coated Tablets 100 Mg

Autoren: Pratibha Thapliyal*, Neha Sodiyal, Shivanand Patil

Schlagwörter: Introduction, Sitagliptin, Process validation, Critical process parameters (CPPs), critical quality attributes (CQAs), and Regulatory guidelines of Process Validation

Formulation and optimization of bicalutamide tablets by using factorial design

Autoren: Roy, Santanu Singh, Gurpreet Kalra, Naresh

Quelle: Research Journal of Pharmacy and Technology 17(10):4796-4802. 2024

Quality by Design (QbD) in pharmaceutical development: A comprehensive review

Autoren: Pratik B. Aru Mayur S. Gulhane Vinayak A. Katekar et al.

Quelle: GSC Biological and Pharmaceutical Sciences. 26:328-340

Schlagwörter: Risk Management, International Conference on Harmonization (ICH), Global Harmonization, Empirical Methods, Predictability, Industry 4.0, Real-time Release Testing (RTRT), Critical Process Parameters (CPPs), Case Studies, Continuous Improvement, Regulatory Compliance, Critical Quality Attributes (CQAs), Consistency, Patient Safety, Advanced Technologies, Quality by Design (QBD) Pharmaceutical Development, Design Space, Paradigm Shift

Impact of the physical-chemical properties of poly(lactic acid)–poly(ethylene glycol) polymeric nanoparticles on biodistribution

Autoren: Jackman, MJ Li, WM Smith, A et al.

Quelle: Jackman, MJ, Li, WM, Smith, A, Workman, D, Treacher, KE, Corrigan, A, Abdulrazzaq, F, Sonzini, S, Nazir, Z, Lawrence, M J, Mahmoudi, N, Cant, D, Counsell, J, Cairns, J, Ferguson, D, Lenz, E, Baquain, S, Madla, CM, van Pelt, S, Moss, J, Peter, A, Puri, S, Ashford, M & Mazza, M 2024, ' Impact of the physical-chemical properties of poly(lactic acid)-poly (ethylene glycol) polymeric nanoparticles on biodistribution ', Journal of Controlled Release, vol. 365, pp. 491-506 . https://doi.org/10.1016/j.jconrel.2023.11.043

Schlagwörter: Bioanalytical assay, Drug Carriers, SANS, Polymers, Characterization, Polyesters, In vitro release, Cryo-TEM, Polyethylene Glycols, Mice, Biodistribution, Critical quality attributes, Animals, Nanoparticles, HAXPES, Tissue Distribution, Particle Size, PLA-PEG

Dateibeschreibung: application/pdf

Zugangs-URL: https://pubmed.ncbi.nlm.nih.gov/38030083
https://research.manchester.ac.uk/en/publications/1cb31e5f-b3af-461e-b549-b42b13214619
https://doi.org/10.1016/j.jconrel.2023.11.043
http://www.scopus.com/inward/record.url?scp=85178640950&partnerID=8YFLogxK
https://www.mendeley.com/catalogue/ca936c82-1ec4-3241-af0e-454f5591c3a6/
https://pure.manchester.ac.uk/ws/files/304348406/COREL-D-23-01687_R1.pdf
https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=pure_starter&SrcAuth=WosAPI&KeyUT=WOS:001133579900001&DestLinkType=FullRecord&DestApp=WOS
https://research.manchester.ac.uk/en/publications/1cb31e5f-b3af-461e-b549-b42b13214619
https://doi.org/10.1016/j.jconrel.2023.11.043

Physicochemical and functional assessment of messenger RNA 5′Cap-end impurities under forced degradation conditions

Autoren: J. Hutchinson F. Schweikart R. Shannon et al.

Quelle: Molecular Therapy: Nucleic Acids, Vol 36, Iss 2, Pp 102570- (2025)

Schlagwörter: MT: oligonucleotides: therapies and applications, RNA, 5′Cap, liquid chromatography-mass spectrometry, critical quality attributes, forced degradation, Therapeutics. Pharmacology, RM1-950

Dateibeschreibung: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2162253125001246; https://doaj.org/toc/2162-2531

Zugangs-URL: https://doaj.org/article/cb9c9660ae7c42f599ad64c243018587