Review on machine learning-based bioprocess optimization, monitoring, and control systems

PP Mondal, A Galodha, VK Verma, V Singh… - Bioresource …, 2023 - Elsevier
Abstract Machine Learning is quickly becoming an impending game changer for
transforming big data thrust from the bioprocessing industry into actionable output. However …

Amorphous solid dispersions: An update for preparation, characterization, mechanism on bioavailability, stability, regulatory considerations and marketed products

P Pandi, R Bulusu, N Kommineni, W Khan… - International journal of …, 2020 - Elsevier
Amorphous solid dispersions (ASDs) are being employed frequently to improve
bioavailability of poorly soluble molecules by enhancing the rate and extant of dissolution in …

Design of experiments (DoE) in pharmaceutical development

S N. Politis, P Colombo, G Colombo… - Drug development and …, 2017 - Taylor & Francis
At the beginning of the twentieth century, Sir Ronald Fisher introduced the concept of
applying statistical analysis during the planning stages of research rather than at the end of …

Clinical manufacturing of CAR T cells: foundation of a promising therapy

X Wang, I Rivière - Molecular Therapy-Oncolytics, 2016 - cell.com
The treatment of cancer patients with autologous T cells expressing a chimeric antigen
receptor (CAR) is one of the most promising adoptive cellular therapy approaches …

Understanding pharmaceutical quality by design

LX Yu, G Amidon, MA Khan, SW Hoag, J Polli… - The AAPS journal, 2014 - Springer
This review further clarifies the concept of pharmaceutical quality by design (QbD) and
describes its objectives. QbD elements include the following:(1) a quality target product …

An overview of experimental designs in HPLC method development and validation

PK Sahu, NR Ramisetti, T Cecchi, S Swain… - … of pharmaceutical and …, 2018 - Elsevier
Chemometric approaches have been increasingly viewed as precious complements to high
performance liquid chromatographic practices, since a large number of variables can be …

Spray drying formulation of amorphous solid dispersions

A Singh, G Van den Mooter - Advanced drug delivery reviews, 2016 - Elsevier
Spray drying is a well-established manufacturing technique which can be used to formulate
amorphous solid dispersions (ASDs) which is an effective strategy to deliver poorly water …

Nanoparticle-based drug delivery systems: a commercial and regulatory outlook as the field matures

H Ragelle, F Danhier, V Préat, R Langer… - Expert opinion on …, 2017 - Taylor & Francis
Introduction: Nanomedicine has emerged as a major field of academic research with direct
impact on human health. While a first generation of products has been successfully …

[HTML][HTML] The future of pharmaceutical manufacturing sciences

J Rantanen, J Khinast - Journal of pharmaceutical sciences, 2015 - Elsevier
The entire pharmaceutical sector is in an urgent need of both innovative technological
solutions and fundamental scientific work, enabling the production of highly engineered …

BCS class IV drugs: Highly notorious candidates for formulation development

R Ghadi, N Dand - Journal of Controlled Release, 2017 - Elsevier
BCS class IV drugs (eg, amphotericin B, furosemide, acetazolamide, ritonavir, paclitaxel)
exhibit many characteristics that are problematic for effective oral and per oral delivery …