Continuous crystallization and its potential use in drug substance Manufacture: A review

A Eren, F Civati, W Ma, JC Gamekkanda… - Journal of Crystal …, 2023 - Elsevier
Interest in the continuous manufacturing in the pharmaceutical industry for the production of
Active Pharmaceutical Ingredients (API's) has greatly increased in recent years. This has led …

Control of crystal nucleation, size and morphology using micro−/nanobubbles as green additives–a review

ID Tegladza, G Lin, C Liu, X Gu - Separation and Purification Technology, 2023 - Elsevier
This review provides a summary of recent studies that addressed the question of whether
micro−/nanobubbles provide heterogeneous substrates to impact metastable zone width …

Prevalence of impurity retention mechanisms in pharmaceutical crystallizations

FL Nordstrom, E Sirota, C Hartmanshenn… - … Process Research & …, 2023 - ACS Publications
The rejection of process impurities from crystallizing products is an essential step for the
purification of pharmaceutical drugs and for the isolation of active pharmaceutical …

Probing the Molecular and Macroscopic Structure of Solid Solutions by Dynamic Nuclear Polarization (DNP) Enhanced 13C and 15N Solid-State NMR Spectroscopy

J Mi, Y Chen, BA Atterberry, FL Nordstrom… - Molecular …, 2024 - ACS Publications
Crystallization is a widely used purification technique in the manufacture of active
pharmaceutical ingredients (APIs) and precursor molecules. However, when impurities and …

Microelectron Diffraction Reveals Contamination of Polymorphs by Structure Analysis of Microscale Crystals in a Novel Pharmaceutical Cocrystal

T Miyano, Y Hirakawa, A Yamano… - Crystal Growth & …, 2023 - ACS Publications
A P2X7 receptor antagonist (basic nature) with possible amino/imino tautomeric forms was
used as an active pharmaceutical ingredient (API). After the amorphous form was confirmed …

Focusing impurities during inert gassing crystallization of complex mixtures

AI Seifert, A Wehning, J Gutsch… - … Process Research & …, 2023 - ACS Publications
Selective crystallization of a pure product from complex mixtures is challenging due to the
variety of impurities which can potentially affect the crystallization process and hence …

Mathematical modeling and optimization to inform impurity control in an industrial active pharmaceutical ingredient manufacturing process

S Diab, C Christodoulou, G Taylor… - … Process Research & …, 2022 - ACS Publications
Mathematical modeling of pharmaceutical manufacturing processes can provide insights
and understanding regarding the key factors impacting product quality. In this study, we …

Case studies in the application of a workflow-based crystallization design for optimized impurity rejection in pharmaceutical development

P Agrawal, SH Rawal, VR Reddy… - … Process Research & …, 2023 - ACS Publications
Crystallization is an important unit operation in pharmaceutical drug substance
manufacturing for the isolation of organic products. Impurity control is a recurring critical …

Integrating Process Development and Safety Analysis for Scale-Up of a Diborane-Generating Reduction Reaction

BM Armstrong, T Behre, BWH Turnbull… - … Process Research & …, 2023 - ACS Publications
Our company has developed a robust and scalable process to synthesize an amino alcohol
tosylate salt, a penultimate intermediate in the synthesis of nemtabrutinib. A key reaction in …

Concomitant Precipitation of Solid-State Miscible Product-Impurity Phases in Solution Crystallization. Part 1: Theoretical Basis and Workflow for Efficient Impurity …

FL Nordstrom, M Paolello, N Yao… - … Process Research & …, 2024 - ACS Publications
Crystallization is routinely employed in industrial chemical synthesis to remove undesired
impurities and obtain the product as a crystalline solid. A common impurity retention …