Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector

23 Sep 2024 | Magazine | Contributor(s): Indu Bhushan

The author explains how continuous manufacturing is reshaping pharmaceutical production

Continuous Manufacturing: Many Want It, But Here's Why Few Have It

20 Feb 2024 | Website | Contributor(s): Ioanna Deni

Continuous manufacturing remains a key objective among bioprocessing professionals. While continuous bioprocessing isn’t a new concept, having been applied in the production of both old and new products, significant technological advancements set the stage for its wider adoption.

Continuous manufacturing: the future in pharmaceutical solid dosage form manufacturing

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Desai, Parind Mahendrakumar, Van Vaerenbergh, Griet, Holman, Jim, Liew, Celine Valeria, Heng, Paul Wan Sia

As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and...

Continuous manufacturing of pharmaceuticals

09 Jun 2023 | Chapter Book | Contributor(s): Johannes Khinast, Jukka Rantanen

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals.As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process...

Continuous Melt Granulation for Taste-Masking of Ibuprofen

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Forster, Seth P., Lebo, David B.

This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and...

Continuous micro feeding and mixing of solid dosage forms under vibrational excitation

08 Oct 2024 | Peer-reviewed journal | Contributor(s): Haifeng Lu, Liang Zhang, Hui Du, Xiaolei Guo, Haifeng Liu

Continuous manufacturing has intrigued many researchers in the pharmaceutical industry in the post-COVID-19 world. We experimentally studied the discharge characteristics of pharmaceutical excipients under vibrational excitation. The successful accurate dosing and filling of powders at fill...

Continuous mixing of powder mixtures with pharmaceutical process constraints

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Berthiaux, H, Marikh, K, Gatumel, C

While it would provide many advantages from many aspects, the application of continuous mixing processes to the pharmaceutical field is still in its infancy. In this paper we report results concerning the continuous mixing of nine ingredients (including three actives) that constitute a current...

Continuous Multiphase Flow Nitration and Cryogenic Flow Formylation: Enabling Process Development and Manufacturing of Pharmaceutical Intermediates

25 Jun 2024 | Peer-reviewed journal | Contributor(s): Cardinal-David, Benoit, Harper, Kaid C., Verma, Anuj, Hanna, David, Caspi, Daniel D., Vitale, Christopher, Bien, Jeffrey T., Wang, Zhe, Diwan, Moiz

Manufacturing API and pharmaceutical intermediates requires the development of scalable, safe, and environmentally friendly processes. Reactions with high exothermicity or otherwise hazardous in nature, as well as reactions involving the formation of unstable intermediates, can benefit from...

Continuous Pharmaceutical Crystallization from Solution

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Price, CJ

Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing

Continuous Pharmaceutical Processing

09 Jun 2023 | Chapter Book | Contributor(s): Zoltan K Nagy, Arwa El Hagrasy, Jim Litster

Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design

Continuous Platinum-Mediated Hydrogenation of Refametinib Iodo-nitroaniline Key Intermediate DIM-NA: The Combined Challenges of Selectivity and Catalyst Deactivation

25 Jun 2024 | Peer-reviewed journal | Contributor(s): Baramov, Todor, Hassfeld, Jorma, Gottfried, Michael, Bauer, Hermann, Herrmann, Tanja, Ben Said, Mourad, Roggan, Stefan

The chemoselective, continuous, multistep reduction of iodo-nitroaromatics in a fixed-bed hydrogenation reactor has been investigated. This transformation poses challenges upon both the catalyst and process conditions if high yields are to be achieved. First, the stability and selectivity of four...

Continuous plug flow crystallization of pharmaceutical compounds

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Alvarez, Alejandro J., Myerson, Allan S.

Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions

Continuous powder feeding for pharmaceutical solid dosage form manufacture: a short review

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Blackshields, Caroline A., Crean, Abina M.

Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products

Continuous processing and the applications of online tools in pharmaceutical product manufacture: developments and examples

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Ooi, Shing Minga, Sarkar, Srimantaa, Van Varenbergh, Grietb, Schoeters, Krisb, Heng, Paul Wan Sia

Continuous processing and production in pharmaceutical manufacturing has received increased attention in recent years mainly due to the industries’ pressing needs for more efficient, cost-effective processes and production, as well as regulatory facilitation. To achieve optimum product quality,...

Continuous Processing in the Manufacture of Active Pharmaceutical Ingredients and Finished Dosage Forms: An Industry Perspective

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Poechlauer, P, Manley, JBroxterman, R, Gregertsen, B, Ridemark, M

Continuous manufacturing as a way of producing fine chemicals, active pharmaceutical ingredients, and finished dosage forms is gaining widespread attention. Although potential benefits over traditional batch-wise production have been discussed at many occasions and appear evident, continuous...

Continuous Processing of Active Pharmaceutical Ingredients Suspensions via Dynamic Cross-Flow Filtration

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Gursch, J, Hohl, RToschkoff, G, Dujmovic, D, Brozio, J, Krumme, M, Rasenack, N, Khinast, J

Over the last years, continuous manufacturing has created significant interest in the pharmaceutical industry. Continuous filtration at low flow rates and high solid loadings poses, however, a significant challenge. A commercially available, continuously operating, dynamic cross-flow filtration...

Continuous Processing. Continuous Evolution

08 Oct 2024 | Magazine | Contributor(s): Douglas Hausner

Continuous processing for small molecule products has been a hot topic for years, but where does the industry stand with it today? We speak with Doug Hausner, Senior Manager, Continuous Manufacturing, Oral Solid Dose, Pharma Services at Thermo Fisher Scientific, to find out.

Continuous Production of Five Active Pharmaceutical Ingredients in Flexible Plug-and-Play Modules: A Demonstration Campaign

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Rogers, L, Briggs, NAchermann, R, Adamo, A, Azad, M, Brancazio, D, Capellades, G, Hammersmith, G, Hart, T, Imbrogno, J, Kelly, LP, Liang, GH, Neurohr, C, Rapp, K, Russell, MG, Salz, C, Thomas, DA, Weimann, L, Jamison, TF, Myerson, AS, Jensen, KF

Traditional pharmaceutical manufacturing is based on a complex supply chain that is vulnerable to spikes in demand and interruptions. Continuous pharmaceutical production in compact modules is a potential solution that allows for drug manufacturing when and where it is needed with significantly...

Continuous purification of active pharmaceutical ingredients using multistage organic solvent nanofiltration membrane cascade

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Peeva, L, Burgal, JDValtcheva, I, Livingston, AG

Downstream processing accounts for a large fraction of the production costs in pharmaceutical manufacturing. Organic solvent nanofiltration performed in a membrane cascade offers an interesting possibility for a continuous downstream processing unit operation. This work demonstrates continuous...

Continuous quantitative monitoring of powder mixing dynamics by near-infrared spectroscopy

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Koller, DM, Posch, A, Horl, G, Voura, C, Radl, S, Urbanetz, N, Fraser, SD, Tritthart, W, Reiter, F, Schlingmann, M, Khinast, JG

FT-NIR spectroscopy with a fiber optical reflection probe was applied as a process analytical technology tool for the continuous quantitative in-line monitoring of pharmaceutical powder mixing processes in a bladed mixer. Two powders, acetyl salicylic acid as an active pharmaceutical ingredient...

Continuous reactive crystallization of an API in PFR-CSTR cascade with in-line PATs

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Hu, CT, Shores, BTDerech, RA, Testa, CJ, Hermant, P, Wu, W, Shvedova, K, Ramnath, A, Al, Ismaili, LQ, Su, QL, Sayin, R, Born, SC, Takizawa, B, O'Connor, TF, Yang, XC, Ramanujam, S, Mascia, S

The continuous reactive crystallization of an active pharmaceutical ingredient (API) in a plug flow reactor (PFR)-continuous stirred tank reactor (CSTR) cascade system with in-line PATs was developed and investigated. Residence time distribution (RTD) measurements of the PFR (stage 1), the CSTR...

Continuous Selective Hydrogenation of Refametinib Iodo-nitroaniline Key Intermediate DIM-NA over Raney Cobalt Catalyst at kg/day Scale with Online UV–Visible Conversion Control

25 Jun 2024 | Peer-reviewed journal | Contributor(s): Said, Mourad Ben, Baramov, Todor, Herrmann, Tanja, Gottfried, Michael, Hassfeld, Jorma, Roggan, Stefan

The continuous selective hydrogenation of the iodo-nitroaromatic refametinib active pharmaceutical ingredient (API) intermediate (2,3-difluoro-5-methoxy-6-nitro-phenyl)-(2-fluoro-4-iodo-phenyl)-amine (DIM-NA) to the corresponding iodo-aniline...

Continuous Single-Step Wet Granulation with Integrated in-Barrel-Drying

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Schmidt, Adrian, de Waard, Hans, Kleinebudde, Peter, Krumme, Markus

Purpose It was investigated if continuous wet granulation and drying could be combined in a twin-screw granulator with the aimto provide (pre-) dried granules in a single-step process, i.e. in-barrel-drying. Methods To have a consistent and robust material propulsionmechanism, a twin-screw...

Continuous synthesis of artemisinin-derived medicines

24 Apr 2024 | Peer-reviewed journal | Contributor(s): Gilmore, Kerry, Kopetzki, Daniel, Lee, Ju Weon, Horváth, Zoltán, McQuade, D. Tyler, Seidel-Morgenstern, Andreas, Seeberger, Peter H.

Described is a continuous, divergent synthesis system which is coupled to continuous purification and is capable of producing four anti-malarial APIs. The system is comprised of three linked reaction modules for photooxidation/cyclization, reduction, and derivatization. A fourth module couples...