Results 41 to 50 of about 62,558,702 (211)

Global Regulatory Perspectives on Quality by Design in Pharma Manufacturing

, 2019
The legislations have almost frozen the processes used in pharmaceutical manufacturing overtime. Even after the receipt of drugs’ permits/certificates, even a small change in the method of manufacturing of medicines requires examination and approval of ...
Aksu, Buket, Gizem Yeğen, Buket Aksu, Yeğen, Yegen Gizem   +3 more
core   +1 more source

Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry [PDF]

, 2017
Quality by Design (QbD) for the pharmaceutical industry includes the design, development and production control of products and production processes from the beginning to the end of the product development phase for ensuring the consistent quality of a ...
Sahin, Nefise Ozlen, Selda Dogan Calhan, Calhan, Selda Dogan, Ebru Derici Eker, Nefise Ozlen Sahin, Eker, Ebru Derici   +5 more
core   +1 more source

Quality by design approach with design of experiment for sample preparation techniques

Advances in Sample Preparation, 2023
The quality by design (QbD) based approach has begun to be embedded in various method development. Studies show that with the design of experiment tool, the analysis process has become more efficient, faster, and easier.
Saniye Özcan, Serkan Levent, Nafiz Öncü Can   +2 more
doaj   +1 more source

Beyond Biomimetics: Pathology‐Informed Engineering Rescues Reconstituted HDL From Inflammatory Dysfunction for Sepsis Immunotherapy

Advanced Science, EarlyView.
A pathology‐informed engineering strategy rescues reconstituted HDL from inflammatory dysfunction in sepsis. By integrating a ceria nanozyme‐celastrol coordination complex, the platform preserves HDL structure and endotoxin handling, sustains hierarchical intracellular delivery, and enhances immunoregulation across pathological models, translating ...
Han Zhou, Lei Zhang, Xingyu Cai, Jiajia Su, Guangyu Dai, Xue Chen, Hanming Wang, Jia Hua, Jianping Liu, Chunmeng Sun, Xiancheng Chen, Erhao Wang, Wenli Zhang   +12 more
wiley   +1 more source

Developing Highly Effective Nanoparticle mRNA Therapeutic for Pediatric Acute Respiratory Distress Syndrome

Advanced Science, EarlyView.
Sepsis‑induced pediatric acute respiratory distress syndrome suppresses FOXF1 in lung endothelial cells which causes life‐threatening lung damage. To counter this, researchers developed nanoparticles that specifically target these cells and deliver FOXF1 mRNA.
Zicheng Deng, Wen Gao, Jonathan Do, Danli Lu, Ying‐Wei Lan, Andreas Damianos, Gautam Verma, Ali Al Siraj, Isabella Lowry, Lance Peter, Nicholas E. Banovich, Fei Sun, Hua He, Tanya V. Kalin, Vladimir V. Kalinichenko   +14 more
wiley   +1 more source

Aspects and Implementation of Pharmaceutical Quality by Design from Conceptual Frameworks to Industrial Applications

Pharmaceutics
Background/Objectives: Quality by Design (QbD) has revolutionized pharmaceutical development by transitioning from reactive quality testing to proactive, science-driven methodologies.
Shiwei Yang, Xingming Hu, Jinmiao Zhu, Bin Zheng, Wenjie Bi, Xiaohong Wang, Jialing Wu, Zimeng Mi, Yifei Wu   +8 more
doaj   +1 more source

QUALITY BY DESIGN (QBD) IN PHARMACEUTICAL INDUSTRY

, 2015
In 2004 US Food and Drug Administration (FDA), as part of the Process Analytical Technology Guidance,introduced the idea of Quality by Design (QbD). The core objective was to design quality into the process andproduct rather than try to check quality of the product at the end of production.
SUPREET KAMBOJ, SHRUTI CHOPRA
openaire   +2 more sources

A Behavior‐Integrated Potency Assay for Quantitative Evaluation of Extracellular Matrix Remodeling by Mesenchymal Stem/Stromal Cells

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, Mee‐Hae Kim, Masahiro Kino‐oka   +2 more
wiley   +1 more source

Quality by design (QbD) in the field of pharmaceuticals - A Review

International Journal of Research in Pharmaceutical Sciences, 2020
The profile of the target product includes all the characteristics of the product like chemical properties, constituents of the product, physical state and formulation of the product, state of the product at which the highest efficacy and lowest efficacy is obtained.
null Jogu. Chandrudu, null Gandhimathi R
openaire   +1 more source

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

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, Udisha Singh, Sachin Dattram Pawar   +2 more
wiley   +1 more source