Optimization of a mAb production process with regard to robustness and product quality using quality by design principles
Sign Up to like & getrecommendations! Published in 2022 at "Engineering in Life Sciences"
DOI: 10.1002/elsc.202100172
Abstract: Quality by Design principles are well described and widely used in biopharmaceutical industry. The characterization of a monoclonal antibody (mAb) production process is crucial for novel process development and control. Yet, the application throughout the… read more here.
Keywords: process; quality design; quality; mab production ... See more keywords
Engineering of Solid Dosage Forms of siRNA-Loaded Lipidoid-Polymer Hybrid Nanoparticles Using a Quality-by-Design Approach.
Sign Up to like & getrecommendations! Published in 2021 at "Methods in molecular biology"
DOI: 10.1007/978-1-0716-1298-9_9
Abstract: Therapy based on RNA interference (RNAi), which can be mediated by exogenous small interfering RNA (siRNA), has potential for the management of diseases at the genetic level by silencing gene function(s). In all eukaryotic cells,… read more here.
Keywords: sirna loaded; quality design; polymer; polymer hybrid ... See more keywords
Orodispersible films: conception to quality by design.
Sign Up to like & getrecommendations! Published in 2021 at "Advanced drug delivery reviews"
DOI: 10.1016/j.addr.2021.113983
Abstract: Orodispersible films (ODFs) are ultra-thin, stamp-sized, elegant, portable and patient-centric pharmaceutical dosage forms that do not need water to be ingested. They are particularly useful for paediatric and geriatric patient populations with special needs such… read more here.
Keywords: films conception; orodispersible films; quality design;
Quality by design approach: Regulatory need
Sign Up to like & getrecommendations! Published in 2017 at "Arabian Journal of Chemistry"
DOI: 10.1016/j.arabjc.2014.01.025
Abstract: Abstract In this era of competition quality has been given prime magnitude; failure to meet such quality allied goals produces massive shift of company in share of market. In this context pharmaceutical industry is utmost… read more here.
Keywords: quality; qbd; chemistry; quality design ... See more keywords
Extension of quality-by-design concept to the early development phase of pharmaceutical R&D processes.
Sign Up to like & getrecommendations! Published in 2018 at "Drug discovery today"
DOI: 10.1016/j.drudis.2018.03.012
Abstract: Here, we propose the extension of the quality-by-design (QbD) concept to also fit the early development phases of pharmaceuticals by adding elements that are currently widely applied, but not yet included in the QbD model… read more here.
Keywords: phase; quality; quality design; extension quality ... See more keywords
Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): An improved dermatokinetic profile for inflammatory disorder(s).
Sign Up to like & getrecommendations! Published in 2017 at "International journal of pharmaceutics"
DOI: 10.1016/j.ijpharm.2016.12.010
Abstract: Present study was designed to prepare and characterize aceclofenac loaded nanostructured lipid carriers (NLCs) employing Quality by Design (QbD)-oriented approach. The NLCs were evaluated for their transdermal penetration potential and stability. Aceclofenac loaded nanostructured lipid… read more here.
Keywords: lipid carriers; quality; quality design; aceclofenac loaded ... See more keywords
Transferosomes as nanocarriers for drugs across the skin: quality by design from lab to industrial scale.
Sign Up to like & getrecommendations! Published in 2019 at "International journal of pharmaceutics"
DOI: 10.1016/j.ijpharm.2019.118817
Abstract: Transferosomes, also known as transfersomes, are ultradeformable vesicles for transdermal applications consisting of a lipid bilayer with phospholipids and an edge activator and an ethanol/aqueous core. Depending on the lipophilicity of the active substance, it… read more here.
Keywords: transferosomes nanocarriers; skin; quality design; scale ... See more keywords
The development and validation of a quality by design based process analytical tool for the inline quantification of Ramipril during hot-melt extrusion.
Sign Up to like & getrecommendations! Published in 2020 at "International journal of pharmaceutics"
DOI: 10.1016/j.ijpharm.2020.119382
Abstract: Continuous processing is superseding conventional batch processing as a means of manufacturing within the pharmaceutical research/industry. This paradigm shift has led to the implementation of Process Analytical Technology (PAT) as a semi-automatic, predictive tool offering… read more here.
Keywords: quality; quality design; quantification ramipril; process ... See more keywords
Quality by design based silymarin nanoemulsion for enhancement of oral bioavailability
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Drug Delivery Science and Technology"
DOI: 10.1016/j.jddst.2017.05.019
Abstract: Abstract Silymarin has been approved as a safe herbal hepatoprotective drug as well as drug of choice for several hepatic disorders. However it suffers from the problem of poor oral bioavailability. In current work silymarin… read more here.
Keywords: silymarin nanoemulsion; oral bioavailability; quality design; drug ... See more keywords
Quality-by-design model in optimization of PEG-PLGA nano micelles for targeted cancer therapy
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Drug Delivery Science and Technology"
DOI: 10.1016/j.jddst.2018.10.009
Abstract: Abstract Poly (D,L-Lactic-co-Glycolic acid) (PLGA) is a biodegradable and biocompatible polymer approved by FDA for clinical uses. Surface functionalization of self-assembly micelles made of PLGA with Poly-Ethylene Glycol (PEG) improves its stability and half-life in… read more here.
Keywords: quality design; model; plga; peg ... See more keywords
Fabrication of efavirenz loaded nano-formulation using quality by design (QbD) based approach: Exploring characterizations and in vivo safety
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Drug Delivery Science and Technology"
DOI: 10.1016/j.jddst.2020.101545
Abstract: Abstract Quality by design (QbD) approach was practically applied in fabrication of nanostructured lipid carrier (NLC) encapsulating efavirenz (EF) to ensure the quality in product. Initially, risk factors were categorized based on risk priority number… read more here.
Keywords: design qbd; fabrication; quality design; approach ... See more keywords