Results 61 to 70 of about 62,558,702 (211)

Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe

Biomedicines, 2022
The vast scope of 3D printing has ignited the production of tailored medical device (MD) development and catalyzed a paradigm shift in the health-care industry, particularly following the COVID pandemic.
Livia Adalbert, S P Yamini Kanti, Orsolya Jójárt-Laczkovich, Hussein Akel, Ildikó Csóka   +4 more
doaj   +1 more source

High‐throughput development and scale‐up of recombinant adeno‐associated virus 5 anion‐exchange chromatography for high‐purity capsid separation

Biotechnology Progress, EarlyView.
High‐throughput anion‐exchange chromatography process development enables scalable purification of high‐purity recombinant adeno‐associated virus capsids. Abstract Recombinant adeno‐associated virus (rAAV) production commonly yields a high proportion of empty and partially filled capsids, necessitating downstream purification to enrich full capsids ...
Kevin Vera, Ivan Gajic, Praveen Kusumanchi, Angela Andaluz, Gabrielle Dela Pena, Clifford A. Froelich, Elizabeth Higgins, Jennifer Johnston, Seyed Pouria Motevalian   +8 more
wiley   +1 more source

From lab to industrial development of lipid nanocarriers using quality by design approach

International Journal of Pharmaceutics: X
Lipid nanocarriers have attracted a great deal of interest in the delivery of therapeutic molecules. Despite their many advantages, compliance with quality standards and reproducibility requirements still constrain their industrial production.
Aristote B. Buya, Phindile Mahlangu, Bwalya A. Witika   +2 more
doaj   +1 more source

Analytical quality-by-design approach for sample treatment of BSA-containing solutions

Journal of Pharmaceutical Analysis, 2015
The sample preparation of samples containing bovine serum albumin (BSA), e.g., as used in transdermal Franz diffusion cell (FDC) solutions, was evaluated using an analytical quality-by-design (QbD) approach.
Lien Taevernier, Evelien Wynendaele, Matthias D׳Hondt, Bart De Spiegeleer   +3 more
doaj   +1 more source

Screening Surface Modifications to Benzene to Improve Solubility in Hydroxyl‐Terminated Polybutadiene (HTPB)—A DFT Demonstration

Propellants, Explosives, Pyrotechnics, EarlyView.
ABSTRACT The objective of this paper is to demonstrate the advantage of computationally pre‐screening surface‐modifying material candidates, using density functional theory (DFT), to inform experimental synthesis and formulation efforts. This demonstration focuses on improving the solubility of benzene‐based materials in hydroxyl‐terminated ...
Samantha E. Knoth
wiley   +1 more source

Effect of Resonant Mixer Granulation Parameters on Prill Properties

Propellants, Explosives, Pyrotechnics, EarlyView.
ABSTRACT Resonant mixing is a promising processing approach to manage mixing of materials with high solids content and has shown strong performance for mixing powders and pastes in energetic materials. This has led to the exploration of the approach for granulation of primary particles into millimeter‐sized agglomerates, including for generating ...
Hannah Cook, S. Emad Renfroe, Jessica Keith, Eleanor E. Radlinski, Albin Darby, Blair Brettmann   +5 more
wiley   +1 more source

Approach of analytical quality by design and regulatory need [PDF]

, 2022
This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceuticals. Quality cannot be tested into products but quality should be built in by design. The concept of QbD can be
Mahapatra, Asmita, Meyyanathan, S. N.
core   +1 more source

Advanced QbD-Based Process Optimization of Clopidogrel Tablets with Insights into Industrial Manufacturing Design

Pharmaceutics
Background/Objectives: Traditional Quality by Testing (QbT) strategies rely heavily on end-product testing and offer limited insight into how critical process parameters (CPPs) influence product quality.
Young Woo Bak, Mi Ran Woo, Hyuk Jun Cho, Taek Kwan Kwon, Ho Teak Im, Jung Hyun Cho, Han-Gon Choi   +6 more
doaj   +1 more source

Nanomedicine applications in lymphoma: Advancing precision diagnostics, targeted therapeutics, and prospective developments

VIEW, EarlyView.
Lymphoma is a group of blood cancers that can appear in lymph nodes, blood, bone marrow, spleen, liver, or the central nervous system, which makes drug delivery and disease monitoring difficult. This review summarizes how nanomedicine technologies may improve targeted treatment and imaging, while carefully separating approved or guideline‐supported ...
Mohd Ahmar Rauf, Yara Mashal, Afeefa Rao, Nasar Ata, Arun K. Iyer, Farhan Shah   +5 more
wiley   +1 more source

Integrating the Quality-by-Design (QbD) Approach in the Development of Febuxostat-loaded Proniosomal Gel for Topical Delivery

Nano Biomedicine and Engineering
Febuxostat (FXT) is useful in treating hyperuricemia and chronic gout. However, it has limited bioavailability orally due to its low solubility and short half-life. This results in the need for more frequent and larger doses, increasing the likelihood of
Rajeshwar V. Kshirsagar, Sujata R. Rajewar, Shreya S. Kokil, Matte Kasi Viswanadh, Ramling G. Patrakar, Datta Maroti Pawde   +5 more
doaj   +1 more source