A critical review of analytical methods for subvisible and visible particles

LO Narhi, Y Jiang, S Cao, K Benedek… - Current …, 2009 - ingentaconnect.com
The subvisible and visible particles present in a solution are often classified based on size,
and are quantified by the actual number of particles present rather than by weight or molar …

Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications

EK Read, RB Shah, BS Riley, JT Park… - Biotechnology and …, 2010 - Wiley Online Library
Implementing real‐time product quality control meets one or both of the key goals outlined in
FDA's PAT guidance:“variability is managed by the process” and “product quality attributes …

Sound practices for consistent human visual inspection

JA Melchore - Aaps Pharmscitech, 2011 - Springer
Numerous presentations and articles on manual inspection of pharmaceutical drug products
have been released, since the pioneering articles on inspection by Knapp and associates …

[BOOK][B] Pat applied in biopharmaceutical process development and manufacturing: an enabling tool for quality-by-design

C Undey, D Low, JC Menezes, M Koch - 2011 - books.google.com
As with all of pharmaceutical production, the regulatory environment for the production of
therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design …

Classification of glass particles in parenteral product vials by visual, microscopic, and spectroscopic methods

S Cao, N Jiao, ZQ Wen - PDA Journal of Pharmaceutical Science …, 2014 - journal.pda.org
Glass vials have been used as primary containers for parenteral drugs including
biopharmaceuticals. Different types of glass-related particles, although in low occurrence …

Considerations for design and use of container challenge sets for qualification and validation of visible particulate inspection

JA Melchore, D Berdovich - PDA Journal of Pharmaceutical Science …, 2012 - journal.pda.org
The major compendia require sterile injectable and ophthalmic drugs, to be prepared in a
manner that is designed to exclude particulate matter. This requirement is satisfied by testing …

[HTML][HTML] Best practices for formulation and manufacturing of biotech drug products

S Singh, A McAuley, N Rathore… - BioPharm …, 2009 - biopharminternational.com
Maintaining product stability during the various drug product process unit operations is
paramount to our ability to supply safe and efficacious biotech products to patients. New …

[HTML][HTML] HOG-SVM Impurity Detection Method for Chinese Liquor (Baijiu) Based on Adaptive GMM Fusion Frame Difference

X Shi, Z Tang, Y Wang, H Xie, L Xu - Foods, 2022 - mdpi.com
Chinese liquor (Baijiu) is one of the four major distilled spirits in the world. At present, liquor
products containing impurities still exist on the market, which not only damage corporate …

Challenges and opportunities for biotech quality by design

C Agarabi, MA Khan, RB Shah - Quality by Design for Biopharmaceutical …, 2015 - Springer
Due to the complex nature of protein therapeutics, there are unique challenges and
opportunities to implement a Quality by Design (QbD) approach for the biotechnology …

Scientific and regulatory overview of process analytical technology in bioprocesses

RB Shah, K Brorson, EK Read, JT Park… - PAT Applied in …, 2011 - books.google.com
Process analytical technology (PAT) is a system for designing, analyzing, and controlling
manufacturing processes based on (1) an understanding of the scientific and engineering …