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Impact of critical process parameters and critical material attributes on the critical quality attributes of liposomal formulations prepared using continuous processing

JOURNAL ARTICLE published May 2022 in International Journal of Pharmaceutics

Research funded by U.S. Food and Drug Administration (1U01FD005773-01)

Authors: Gowtham Yenduri | Antonio P. Costa | Xiaoming Xu | Diane J. Burgess

Quality Risk Management (QRM): Part II – Evaluating the Impact of Process Parameters on Critical Quality Attributes for Biopharmaceutical Products

JOURNAL ARTICLE published 15 February 2017 in BioProcessing Journal

Authors: Mark Witcher | NNE

Oral Soluble Films: Attributes of the Polymeric Material and Critical Process Parameters for Designing Good Quality Films

JOURNAL ARTICLE published 15 December 2020 in Current Applied Polymer Science

Authors: Suhani Sinha | Rohit Dutt

Assessment of topical semisolid products to design a critical quality attributes and performance based evaluation matrix


Authors: Maryam Dabbaghi

Performance-Based Quality Specifications: The Relationship Between Process Critical Control Parameters, Critical Quality Attributes, and Clinical Performance

JOURNAL ARTICLE published April 2011 in Journal of Pharmaceutical Sciences

Authors: Steven M. Short | Robert P. Cogdill | James K. Drennen | Carl A. Anderson

QbD-Based Film Manufacturing: Impact of Material Attributes and Process Parameters on Quality Attributes


Authors: Srinivasan Shanmugam


JOURNAL ARTICLE published 1 June 2019 in International Journal of Applied Pharmaceutics

Authors: ROSHNI VORA | Yamini Shah

Revisiting MSC expansion from critical quality attributes to critical culture process parameters

JOURNAL ARTICLE published August 2017 in Process Biochemistry

Authors: Céline Martin | Éric Olmos | Marie-Laure Collignon | Natalia De Isla | Fabrice Blanchard | Isabelle Chevalot | Annie Marc | Emmanuel Guedon

Identifying and leveraging viral vector critical quality attributes & critical process parameters using process analytical technologies

JOURNAL ARTICLE published 19 July 2023 in Cell and Gene Therapy Insights

Authors: Jonathan Appleby | John Churchwell

Online/At-line Measurement, Analysis and Control of Product Titer & Critical Product Quality Attributes (CQAs) During Process Development


Authors: Letha Chemmalil

Critical Quality Attributes, Specifications, and Control Strategy

BOOK CHAPTER published 2015 in Quality by Design for Biopharmaceutical Drug Product Development

Authors: Timothy Schofield | David Robbins | Guillermo Miró-Quesada

Tinjauan Critical Quality Attributes (Cqa) dan Critical Process Parameter (Cpp) Sebagai Bagian dari Pendekatan Quality by Design dalam Proses Pengembangan Tablet Salut Selaput Film

JOURNAL ARTICLE published 28 May 2022 in Majalah Farmasetika

Authors: Alifia Syifa Pebriani | Sandra Megantara | Rina Wijayanti

Application of a Statistical Approach to Process Development of Futibatinib by Employing Quality-by-Design Principles. Part 1: Identification of Critical Process Parameters for Impurities

COMPONENT published

A robust dual-mode MPC approach to ensuring critical quality attributes in Quality-by-Design

PROCEEDINGS ARTICLE published July 2016 in 2016 American Control Conference (ACC)

Authors: Eranda Harinath | Lucas C. Foguth | Richard D. Braatz

Critical Quality Attributes

BOOK CHAPTER published 3 September 2018 in Analytical Similarity Assessment in Biosimilar Product Development

Authors: Shein-Chung Chow

Comprehensive Study of Intermediate and Critical Quality Attributes for Process Control of High-Shear Wet Granulation Using Multivariate Analysis and the Quality by Design Approach

JOURNAL ARTICLE published 1 June 2019 in Pharmaceutics

Research funded by National Research Foundation of Korea (2016R1D1A1B03931513)

Authors: Jong Kwon Han | Beom Soo Shin | Du Hyung Choi

Quality by Design for Herbal Drugs: a Feedforward Control Strategy and an Approach to Define the Acceptable Ranges of Critical Quality Attributes

JOURNAL ARTICLE published January 2014 in Phytochemical Analysis

Authors: Binjun Yan | Yao Li | Zhengtai Guo | Haibin Qu

Determination of critical quality attributes of mesenchymal stem cell by defining critical process parameters and efficacy of the product

JOURNAL ARTICLE published May 2020 in Cytotherapy

Authors: S. Kawamata | T. Yamamoto | M. Arita | K. Suzuki | H. Kawamura | T. Suzuki | D. Margettes

Effect of Formulation and Process Variables on the Critical Quality Attributes of Warfarin Sodium Tablets


Authors: Akhtar Siddiqui

Evaluation of the impact of critical quality attributes and critical process parameters on quality and stability of parenteral nutrition nanoemulsions

JOURNAL ARTICLE published June 2017 in Journal of Drug Delivery Science and Technology

Authors: Dušica Mirković | Svetlana Ibrić | Bojana Balanč | Željko Knez | Branko Bugarski