Results 31 to 40 of about 329 (162)

Application of AQbD to cIEF of Protein Biopharmaceuticals [PDF]

Biomedical Journal of Scientific & Technical Research, 2019
Protein biopharmaceuticals like monoclonal antibodies (mAbs), recombinant and therapeutic proteins are recently in widespread treated of various diseases including cancer, autoimmune disease, cardiovascular, hematology and so on...
openaire   +1 more source

Process analytical technique (PAT) miniaturization for monoclonal antibody aggregate detection in continuous downstream processing

Journal of Chemical Technology &Biotechnology, Volume 97, Issue 9, Page 2347-2364, September 2022., 2022
Abstract The transition to continuous biomanufacturing is considered the next step to reduce costs and improve process robustness in the biopharmaceutical industry, while also improving productivity and product quality. The platform production process for monoclonal antibodies (mAbs) is eligible for continuous processing to lower manufacturing costs ...
Mariana N São Pedro, Marieke E Klijn, Michel HM Eppink, Marcel Ottens   +3 more
wiley   +1 more source

Sixteen capillary electrophoresis applications for viral vaccine analysis

ELECTROPHORESIS, Volume 43, Issue 9-10, Page 1068-1090, May 2022., 2022
Abstract A broad range of CE applications from our organization is reviewed to give a flavor of the use of CE within the field of vaccine analyses. Applicability of CE for viral vaccine characterization, and release and stability testing of seasonal influenza virosomal vaccines, universal subunit influenza vaccines, Sabin inactivated polio vaccines ...
Lars Geurink, Ewoud van Tricht, Debbie van der Burg, Gerard Scheppink, Bojana Pajic, Justin Dudink, Cari Sänger–van de Griend   +6 more
wiley   +1 more source

Quality‐by‐Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource‐Limited Setting: The Lab Water

International Journal of Analytical Chemistry, Volume 2022, Issue 1, 2022., 2022
Quality‐by‐design (QbD) is defined as a systematic approach to design and develop a product/service based on sound science and quality risk management. It is already frequently applied in the pharmaceutical industry mainly in the development of pharmaceutical products and analytical methods but is not well established in the setup of facilities like ...
Sultan Suleman, Sileshi Belew, Dereje Kebebe, Markos Duguma, Henok Teshome, Gemmechu Hasen, Evelien Wynendaele, Luc Duchateau, Bart De Spiegeleer, Eladia M. Pena Mendez   +9 more
wiley   +1 more source

The analysis of cannabinoids in cannabis samples by supercritical fluid chromatography and ultra‐high‐performance liquid chromatography: A comparison study

Analytical Science Advances, Volume 2, Issue 1-2, Page 2-14, February 2021., 2021
Abstract The aim of this work was to develop a supercritical fluid chromatographic method to study the applicability of this emerging technique to cannabinoid analysis and showcase its advantages. During method development, the authors focused on nine phyto‐cannabinoids to assess the selectivity needed to potentially perform the quantitation of each ...
Riccardo Deidda, Cédric Schelling, Jean‐Marc Roussel, Amandine Dispas, Charlotte De Bleye, Éric Ziemons, Philippe Hubert, Jean‐Luc Veuthey   +7 more
wiley   +1 more source

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

International Journal of Analytical Chemistry, 2015
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach.
Ramalingam Peraman, Kalva Bhadraya, Yiragamreddy Padmanabha Reddy   +2 more
doaj   +1 more source

AQbD-Oriented UHPLC/MS/MS Method Development for Glycopeptides Assessment in Pharmaceutical Forms

Journal of Chromatographic Science, 2021
Abstract Vancomycin and teicoplanin are glycopeptide antibacterials that inhibit the bacteria cell wall synthesis showing activity against gram-positive bacteria. Development of the sensitive method is of great importance for quality control of these drugs that are fermentation products.
A, Stajić, J, Janković-Maksić, B, Jančić-Stojanović, M, Medenica   +3 more
openaire   +2 more sources

Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

Journal of Chemistry, 2015
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT
N. V. V. S. S. Raman, Useni Reddy Mallu, Hanimi Reddy Bapatu   +2 more
doaj   +1 more source

Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach

Chemosensors, 2021
An Analytical Quality by Design (AQbD) approach is presented, aiming at the development and validation of an HPLC method for the quantification of disulfiram and copper diethyldithiocarbamate in lipid nanoparticles.
João Basso, Maria Luísa Ramos, Alberto Pais, Rui Vitorino, Ana Fortuna, Carla Vitorino   +5 more
doaj   +1 more source

Environmental benign RP-HPLC method for the simultaneous estimation of anti-hypertensive drugs using analytical quality by design

Green Chemistry Letters and Reviews, 2023
Green analytical procedures replace harmful organic modifiers with green solvents without affecting chromatographic performance, enabling industries and research laboratories to develop green analytical methods.
Naveenarani Dharuman, Karunanidhi Santhana Lakshmi, Manikandan Krishnan   +2 more
doaj   +1 more source