A review on the modernization of pharmaceutical development and manufacturing–Trends, perspectives, and the role of mathematical modeling

F Destro, M Barolo - International Journal of Pharmaceutics, 2022 - Elsevier
Recently, the pharmaceutical industry has been facing several challenges associated to the
use of outdated development and manufacturing technologies. The return on investment on …

Feasibility/Flexibility-based optimization for process design and operations

H Tian, JS Jagana, Q Zhang, M Ierapetritou - Computers & Chemical …, 2024 - Elsevier
This paper provides an overview of concepts and computational approaches for the
evaluation of feasibility/flexibility and how they can be used for process design and process …

QbD-steered development and validation of an RP-HPLC method for quantification of ferulic acid: Rational application of chemometric tools

S Saini, T Sharma, A Patel, R Kaur, SK Tripathi… - … of Chromatography B, 2020 - Elsevier
The present work describes the systematic development of a simple, rapid, sensitive, robust,
effective and cost-effective reversed-phase high performance liquid chromatographic …

Computational modeling and optimization of biofabrication in Tissue Engineering and Regenerative Medicine-a literature review

R Bardini, SD Carlo - bioRxiv, 2023 - biorxiv.org
Biofabrication is the generation of biologically functional products from living cells and
biomaterials through bioprinting and subsequent maturation processes. Technological and …

A novel adaptive sampling based methodology for feasible region identification of compute intensive models using artificial neural network

N Metta, R Ramachandran, M Ierapetritou - AIChE Journal, 2021 - Wiley Online Library
Identification of feasible region of operations in multivariate processes is a problem of
interest in several fields. This is particularly challenging when the process model is black …

Design space determination of pharmaceutical processes: Effects of control strategies and uncertainty

M Geremia, F Bezzo, MG Ierapetritou - European Journal of Pharmaceutics …, 2024 - Elsevier
The identification of process Design Space (DS) is of high interest in highly regulated
industrial sectors, such as pharmaceutical industry, where assurance of manufacturability …

Novel flexibility index formulations for the selection of the operating range within a design space

MP Ochoa, S García-Muñoz, S Stamatis… - Computers & Chemical …, 2021 - Elsevier
The importance of the Design Space (DS) definition lies in the assurance of quality, a key
goal of Quality by Design, and in the broadening from a single acceptable operating point, to …

PharmaPy: An object-oriented tool for the development of hybrid pharmaceutical flowsheets

D Casas-Orozco, D Laky, V Wang, M Abdi… - Computers & chemical …, 2021 - Elsevier
Process design and optimization continue to provide computational challenges as the
chemical engineering and process optimization communities seek to address more complex …

A novel framework for the identification of complex feasible space

M Geremia, F Bezzo, MG Ierapetritou - Computers & Chemical Engineering, 2023 - Elsevier
Feasibility analysis is suitable to determine the combinations of input parameters that satisfy
all operating and quality constraints, ie, the process design space. In the presence of disjoint …

A dynamic and probabilistic design space determination method for mesenchymal stem cell cultivation processes

K Hirono, I A. Udugama, Y Hayashi… - Industrial & …, 2022 - ACS Publications
A five-step method is proposed for determining the design space of mesenchymal stem cell
(MSC) cultivation processes incorporating system dynamics and variabilities. The method …