Continuous Manufacturing Knowledge Center

Modeling-Assisted Design of Thermostable Benzaldehyde Lyases from Rhodococcus erythropolis for Continuous Production of alpha-Hydroxy Ketones

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Peng, M, Siebert, DLEngqvist, MKM, Niemeyer, CM, Rabe, KS

Enantiopure alpha-hydroxy ketones are important building blocks of active pharmaceutical ingredients (APIs), which can be produced by thiamine-diphosphate-dependent lyases, such as benzaldehyde lyase. Here we report the discovery of a novel thermostable benzaldehyde lyase from Rhodococcus...

Modelling protein crystallisation using morphological population balance models

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Liu, Jing J., Ma, Cai Y. Hu, Yang D., Wang, Xue Z.

Protein crystallisation is known to be affected by many factors and inherently difficult to control. Being able to model the crystal growth behaviour, especially at process scale for the population of particles in a crystalliser will no doubt greatly help the formulation and controlled...

Modelling the primary drying step for the determination of the optimal dynamic heating pad temperature in a continuous pharmaceutical freeze-drying process for unit doses

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): De Meyer, Laurens, Lammens, Joris, Mortier, Severine Therese F. C., Vanbillemont, Brecht, Van Bockstal, Pieter Jan, Corver, Jos, Nopens, Ingmar, Vervaet, Chris, De Beer, Thomas

In the pharmaceutical industry, traditional freeze-drying of unit doses is a batch-wise process associated with many disadvantages. To overcome these disadvantages and to guarantee a uniform product quality and high process efficiency, a continuous freeze-drying process is developed and...

Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Lee, SL, O'Connor, TFYang, XC, Cruz, CN, Chatterjee, S, Madurawe, RD, Moore, CMV, Yu, LX, Woodcock, J

Currently, there is a high level of interest in the pharmaceutical industry in continuous-manufacturing strategies, integrated with online-monitoring tools, that are designed, optimized, and controlled using advanced, model-predictive systems. These strategies can accelerate the full...

Modular Synthesis of Benzoylpyridines Exploiting a Reductive Arylation Strategy

0.0 out of 5 stars

25 Jun 2024 | Contributor(s): Alfano, Antonella Ilenia, Smyth, Megan, Wharry, Scott, Moody, Thomas S., Baumann, Marcus

Herein we disclose a telescoped flow strategy to access electronically differentiated bisaryl ketones as potentially new and tunable photosensitizers containing both electron-rich benzene systems and electron-deficient pyridyl moieties. Our approach merges a light-driven (365 nm) and...

Monitoring and digital design of the cooling crystallization of a high-aspect ratio anticancer drug using a two-dimensional population balance model

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): SzilÃ¡gyi, Botond, Eren, AyÅŸe Quon, Justin L. Papageorgiou, Charles D., Nagy, ZoltÃ¡n K.

The development of a process model for the batch cooling crystallization of an anticancer drug from Takeda Pharmaceuticals is presented. The compound forms needle-like crystals that exhibit significant variation in shape (aspect ratio) during the crystallization. The parameters of a...

Monitoring blend potency in a tablet press feed frame using near infrared spectroscopy

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Ward, Howard, Blackwood, Daniel, Polizzi, Mark, Clarke, Hugh

A near-infrared (NIR) probe was installed into the feed frame of a rotary tablet press to monitor API concentration as a function of time. A series of step change experimental trials were completed, where a placebo blend was initially charged into the feed frame, and an active blend was layered...

Monitoring Continuous Crystallization of Paracetamol in the Presence of an Additive Using an Integrated PAT Array and Multivariate Methods

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Powell, Keddon A., Saleemi, Ali N, Rielly, Chris D., Nagy, Zoltan K.

In this study, an automated intelligent decision support (IDS) framework was applied to monitor the continuous crystallization of form I paracetamol (PCM) and determine steady-state operation. A modified single-stage mixed suspension mixed product removal (MSMPR) crystallizer was used to...

Monitoring Devices - Time, Temperature, Humidity

0.0 out of 5 stars

09 Jun 2023

Standard explains intricacies associated with various monitoring tools for use in process monitoring settings.

Monitoring ibuprofen–nicotinamide cocrystal formation during solvent free continuous cocrystallization (SFCC) using near infrared spectroscopy as a PAT tool

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Kelly, A.L., Gough, T., Dhumal, R.S., Halsey, S.A., Paradkar, A.

The purpose of this work was to explore NIR spectroscopy as a PAT tool to monitor the formation of ibuprofen and nicotinamide cocrystals during extrusion based solvent free continuous cocrystallization (SFCC). Drug and co-former were gravimetrically fed into a heated co-rotating twin screw...

Monitoring of Batch Industrial Crystallization with Growth, Nucleation, and Agglomeration. Part 1: Modeling with Method of Characteristics

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Porru, Marcella, Ã–zkan, Leyla

This paper develops a new simulation model for crystal size distribution dynamics in industrial batch crystallization. The work is motivated by the necessity of accurate prediction models for online monitoring purposes. The proposed numerical scheme is able to handle growth, nucleation, and...

Monitoring of the combined cooling and antisolvent crystallisation of mixtures of aminobenzoic acid isomers using ATR-UV/vis spectroscopy and FBRM

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Saleemi, AN, Rielly, CD, Nagy, ZK

During the manufacturing of active pharmaceutical ingredients crystalline products in the purest forms are required. Quite often multiple components are present during crystallisation, which requires their continuous monitoring and finally separation. The current work demonstrates the application...

Monitoring the concentration of flowing pharmaceutical powders in a tableting feed frame

0.0 out of 5 stars

09 Jun 2023 | Contributor(s): Gosselin, Ryan, Durão, Pedro, Abatzoglou, Nicolas, Guay, Jean-Maxime

The use of process analytical technology (PAT) tools is increasing steadily in the pharmaceutical industry. Such tools are now located throughout the process. When producing tablets, the tableting step itself may be the ideal moment to assess final product composition. Being the last unit...

MOOC 1 Introduction to Continuous Manufacturing

0.0 out of 5 stars