Sensors and chemometrics in downstream processing

A Dürauer, A Jungbauer… - Biotechnology and …, 2023 - Wiley Online Library
The biopharmaceutical industry is still running in batch mode, mostly because it is highly
regulated. In the past, sensors were not readily available and in‐process control was mainly …

Process intensification through continuous spherical crystallization using an oscillatory flow baffled crystallizer

R Peña, JA Oliva, CL Burcham, DJ Jarmer… - Crystal Growth & …, 2017 - ACS Publications
Drug substance purification by crystallization is a key interface in going from drug substance
synthesis to final formulation and can often be a bottleneck in process efficiency. There has …

Toward biotherapeutic product real-time quality monitoring

A Guerra, M von Stosch, J Glassey - Critical reviews in …, 2019 - Taylor & Francis
Biotherapeutics, such as those derived from monoclonal antibodies (mAbs), are industrially
produced in controlled multiunit operation bioprocesses. Each unit operation contributes to …

[HTML][HTML] Interpretable artificial neural networks for retrospective QbD of pharmaceutical tablet manufacturing based on a pilot-scale developmental dataset

B Nagy, Á Szabados-Nacsa, G Fülöp… - International Journal of …, 2023 - Elsevier
As the pharmaceutical industry increasingly adopts the Pharma 4.0. concept, there is a
growing need to effectively predict the product quality based on manufacturing or in-process …

[HTML][HTML] Challenges and opportunities on nonlinear state estimation of chemical and biochemical processes

R Alexander, G Campani, S Dinh, FV Lima - Processes, 2020 - mdpi.com
This paper provides an overview of nonlinear state estimation techniques along with a
discussion on the challenges and opportunities for future work in the field. Emphasis is given …

Process analytical technology-based (PAT) model simulations of a combined cooling, seeded and antisolvent crystallization of an active pharmaceutical ingredient …

M Trampuž, D Teslić, B Likozar - Powder Technology, 2020 - Elsevier
Crystallization is one of the most important unit operations for production of active
pharmaceutical ingredients (API) in pharmaceutical industry. This work studied the impact of …

Application of process analytical technology-based feedback control strategies to improve purity and size distribution in biopharmaceutical crystallization

E Simone, W Zhang, ZK Nagy - Crystal Growth & Design, 2015 - ACS Publications
Purity is a critical quality attribute for both pharmaceutical and biopharmaceutical products.
The presence of impurities (solvents, salts, or byproducts of the synthetic path) in drugs can …

Reaction monitoring using SABRE-hyperpolarized benchtop (1 T) NMR spectroscopy

O Semenova, PM Richardson, AJ Parrott… - Analytical …, 2019 - ACS Publications
The conversion of [IrCl (COD)(IMes)](COD= cis, cis-1, 5-cyclooctadiene, IMes= 1, 3-bis (2, 4,
6-trimethyl-phenyl) imidazole-2-ylidene) in the presence of an excess of para-hydrogen (p …

Compact capillary high performance liquid chromatography system for pharmaceutical on-line reaction monitoring

LJ Coates, A Gooley, SC Lam, B Firme, PR Haddad… - Analytica Chimica …, 2023 - Elsevier
Due to their size, conventional high performance liquid chromatographs (HPLCs) are difficult
to place close to a reaction vessel within a pharmaceutical manufacturing or development …

[HTML][HTML] Characterization and modelling of antisolvent crystallization of salicylic acid in a continuous oscillatory baffled crystallizer

CJ Brown, JA Adelakun, X Ni - Chemical Engineering and Processing …, 2015 - Elsevier
Using antisolvent crystallisation of salicylic acid as the model process, we report our
experimental investigation into the temporal and spatial steady states of solution …