Results 51 to 60 of about 6,391 (215)
, 2011 The misapplication of QbD for purposes for which it was not intended for is unwise andlikely to be counterproductive. It would be a shame if, by virtue of such misapplication, the QbD paradigm were to be maligned or abandoned, because there is no denying
Apte, Shireesh, Shireesh Apte
core
Implementing greening into design in analytical chemistry
Talanta Open, 2022 From the pharmaceutical industry is known the approach Quality-by-Design (QbD) and this has great influence on analytical methods and procedures it employs.
Jelena Jurjeva, Mihkel Koel
doaj +1 more source
Biotechnology and Bioengineering, EarlyView.ABSTRACT Reliable potency assays are critical for ensuring the therapeutic consistency and manufacturing quality of mesenchymal stem/stromal cells (MSCs). Conventional assays based on soluble factor quantification often fail to capture extracellular matrix (ECM) remodeling capacity and exhibit high variability.
Shao Ying Tan +2 more
wiley +1 more source
QbD: The cost of doing business [PDF]
, 2015 The premise of the current iteration of QbD focusing unduly on canned compliance using an unsuitable statistical model, of not adding anything to the bottom line, of not rewarding better processes and quality and not lending itself to the scientific ...
Apte, Shireesh, Shireesh Apte
core
Quality-by-design in pharmaceutical development: From current perspectives to practical applications
Acta Pharmaceutica, 2021 Current pharmaceutical research directions tend to follow a systematic approach in the field of applied research and development. The concept of quality-by-design (QbD) has been the focus of the current progress of pharmaceutical sciences. It is based on,
Kovács Béla +6 more
doaj +1 more source
Journal of Korean Society for Quality Management, 2022 Purpose: This study proposes the application of Six Sigma management innovation method for more systematically enhanced execution of Quality by Design (QbD) activities. QbD requires a deeper understanding of the product and process at the design and development stage of the drug, and it is very important to ensure that no fault is fundamentally ...
Kang Hee Kim, Hyun-jung Kim
openaire +1 more source
Biotechnology and Bioengineering, EarlyView.Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga +2 more
wiley +1 more source
Journal of Clinical and Translational Science, 2021 Introduction: Clinical trials are a critical step in the meaningful translation of biomedical discoveries into effective diagnostic and therapeutic interventions.
Hamid Moradi +3 more
doaj +1 more source
Biotechnology and Bioengineering, EarlyView.ABSTRACT Continuous downstream processing of messenger ribonucleic acid (mRNA) therapeutics requires purification strategies that are scalable, robust, and capable of removing product‐ and process‐related impurities from in vitro transcription mixtures.
Rajan R. Bhawnani +8 more
wiley +1 more source
Bridging the translational gap in clinical nanomedicine: From rational design to clinical reality
BMEMat, EarlyView.Nanotechnology offers a multi‐faceted approach to modern healthcare, encompassing high‐sensitivity diagnostic imaging, innovative vaccine delivery, and targeted therapeutics. This review explores how these nanomedicine applications address critical challenges in cancer recurrence and the treatment of neurologic and respiratory diseases to combat rising
Ahmed H. Ghonaim +9 more
wiley +1 more source