Results 11 to 20 of about 11,237,275 (282)

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

open access: yesFrontiers in Bioengineering and Biotechnology
Mesenchymal stem/stromal cells (MSCs) have been identified as a promising therapeutic option for osteoarthritis, graft vs. host disease and cardiovascular diseases, among others.
Laura Herbst   +3 more
doaj   +3 more sources

Critical Quality Attribute Investigation and Analytical Method Establishment for Glyco-Site-Specific Anti-HER2 Bispecific ADC [PDF]

open access: yesPharmaceuticals
Background/Objectives: Bispecific antibody–drug conjugates (bispecific ADCs) are among the most rapidly advancing antibody therapeutic modalities, with only one product (BL-B01D1) currently approved for marketing worldwide to date.
Xiaojuan Yu   +9 more
doaj   +2 more sources

QbD enabled Process Variable Study to Develop Sustained Release Chitosan-Alginate Embedded Delivery System for Improved Patient Compliance

open access: yesBrazilian Journal of Pharmaceutical Sciences, 2022
The current investigation entail systematic Quality by Design (QbD)-enabled approach for the development of Sustained released embedded drug delivery systems of L-Arginine employing ionic gelation technique to attain improved patient compliance.
Vijay Sharma, Lalit Singh, Navneet Verma
doaj   +1 more source

QUADICA: A large-sample data set of water quality, discharge and catchment attributes for Germany [PDF]

open access: yes, 2022
Environmental data are critical for understanding and managing ecosystems, including mitigation of degraded water quality. Therefore, we provide the first large-sample water quality data set of riverine water quality combined with water quantity ...
Nguyen, Tam   +10 more
core   +2 more sources

Application of Quality-by-Design Approach to Justify the Composition and Technology of Two-component Suppositories

open access: yesРазработка и регистрация лекарственных средств, 2022
Introduction. One of the modern remedies used to treat vaginal infections are suppositories "Depantol", which have an antiseptic, regenerating effect due to the combination of chlorhexidine and dexpanthenol.
I. E. Smekhova   +4 more
doaj   +1 more source

Lot-to-Lot Variance in Immunoassays—Causes, Consequences, and Solutions

open access: yesDiagnostics, 2023
Immunoassays, which have gained popularity in clinical practice and modern biomedical research, play an increasingly important role in quantifying various analytes in biological samples.
Yunyun Luo   +5 more
doaj   +1 more source

Evaluation of Critical Quality Attributes of Dapsone Gel

open access: yesDissolution Technologies, 2023
The purpose of this study was to evaluate critical quality attributes (CQAs) of dapsone gel compared to its marketed reference gel, in accordance with United States Pharmacopeia and draft guidance established by United States Food and Drug Administration, which are based on suggestions about quality and performance of the semi-solid dosage forms in ...
Kalami, Elmira   +5 more
openaire   +2 more sources

Analytical methods for process and product characterization of recombinant adeno-associated virus-based gene therapies

open access: yesMolecular Therapy: Methods & Clinical Development, 2021
The optimization of upstream and downstream processes for production of recombinant adeno-associated virus (rAAV) with consistent quality depends on the ability to rapidly characterize critical quality attributes (CQAs). In the context of rAAV production,
Andreas L. Gimpel   +11 more
doaj   +1 more source

Comparative Assessment of Critical Quality Attributes of Sildenafil Tablets

open access: yesDissolution Technologies, 2021
Fil: Brevedan, Marta Ingrid Victoria. Universidad Nacional del Sur.
Brevedan, Marta Ingrid Victoria   +2 more
openaire   +2 more sources

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