Search results for manufacturing processes - 826 results

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Elevating pharmaceutical manufacturing processes with real-time insights

4 December 2023 | By Martin Gadsby (Optimal)

(Bio)pharmaceutical manufacturing is changing considerably, with key innovations enabling companies to rethink R&D, manufacturing, quality control and quality assurance (QC/QA) operations. The spotlight is squarely on process analytical technology (PAT), which underpins the successful transition towards highly effective advanced manufacturing strategies. Martin Gadsby, Chairman of Optimal Industrial Technologies, looks at how this transformative approach…

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Raman spectroscopy for the analysis of drug products and drug manufacturing processes

9 May 2010 | By Prof. Thomas De Beer, Assistant-Professor, Process Analytical Technology, Faculty of Pharmaceutical Sciences, University of Ghent

This article aims at supplying a concise overview on the application of Raman spectroscopic analysis methods within the pharmaceutical drug product manufacturing world. Firstly, there will be a focus on the rapid and nondestructive off-line analysis feasibility of Raman spectroscopy for final drug products. Herewith, several possible sources of error…

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Applying PAT in pharmaceutical processes

1 November 2010 | By Mario Hellings, Tom Van den Kerkhof, Jeroen Geens and Steve Mehrman, Johnson & Johnson

As cited by the FDA, “Process Analytical Technology (PAT) is a system for designing, analysing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.”1 The main goal of PAT…

Whitepapers/App Notes/Posters

Case study: Merck Leverages Data and Analytics to Support New Continuous Drug Manufacturing Processes

29 July 2019 | By OSIsoft

Over the past couple of years, the European Medicines Agency and US Food and Drug Administration have given approvals to a handful of pharmaceutical companies to manufacture drug products using continuous manufacturing processes.

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NIR spectroscopy for monitoring of industrial manufacturing processes

7 February 2017 | By Metrohm Appllikon

When it comes to monitoring industrial manufacturing processes, NIRS offers a rapid and reliable supplement to conventional titration methods...

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Designing a novel continuous manufacturing plant with superior monitoring and control

6 January 2016 | By Ravendra Singh, Jun Zhang, Marianthi Ierapetritou and Rohit Ramachandran, The State University of New Jersey

There is a growing interest in manufacturing the pharmaceutical product continuously . Along with other advantages , it provides an appropriate platform to implement suitable monitoring and control architecture, to improve the product quality and minimise product rejection and operating expenses. Continuous pharmaceutical manufacturing can be also considered as a…

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Continuous manufacturing: regulatory and quality assurance challenges

22 August 2017 | By Dave Elder, Ronak Savla, Stephen Tindal

During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…

Whitepapers/App Notes/Posters

Brochure: The Caliber Manufacturing Suite – CaliberBRM

28 February 2023 | By Caliber Technologies

CaliberBRM is a manufacturing product suite that digitalises and automates pharmaceutical manufacturing processes for a paperless, future-ready lab.

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Under the microscope: Mitigating risks in manufacturing processes

18 February 2020 | By Andrew Anderson (ACD/Labs)

In the light of recent media coverage about product recalls – particularly resulting from the detection and presence of NDMA – this article outlines ways to avoid the wide-ranging negative impacts on patients, pharmacies, manufacturers, pharmaceutical companies and health authorities and offers ways to mitigate the risk of future recalls.

Whitepapers/App Notes/Posters

Whitepaper: PAT leads the way in the adoption of continuous manufacturing processes

14 September 2022 | By Bruker Biospin

Martin Gadsby, CEO & Director at Optimal Industrial Technologies and Flavio Belvedere, Co-Founder of ABCS Srl, look at the benefits of PAT and the aspects to consider when deploying it.

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Monitoring and controlling drug products and manufacturing processes with NIRS

24 February 2017 | By Dave Elder (David P Elder Constultancy)

Near-infrared spectroscopy (NIRS) is a rapid and non-destructive analytical technique that is important in analysing or profiling both solid and liquid dosage forms, as well as biotechnological products...

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Modernising the supply chain using continuous manufacturing

15 November 2017 | By Dave Elder, Ronak Savla, Stephen Tindal

When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1

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Process analytics for the new era of continuous RNA manufacturing

24 March 2024 | By Dr Edita Botonjic-Sehic

In this article, Edita Botonjic-Sehic, Head of Process Analytics and Data Science at ReciBioPharm, examines the need for a digitally controlled continuous manufacturing process to correct the shortcomings of the current standard of batch processing. She highlights the critical role in-line process analytic technologies (PAT), automation and real-time data analytics…

webinar

Fit-for-purpose miniature NIR spectroscopy for solid dosage manufacturing

ON-DEMAND | By Viavi Solutions Inc.

This webinar discusses how miniaturised spectrometers facilitate testing of different control schemes with the goal of enabling real-time feedback control of continuous manufacturing processes...

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Control strategies in the manufacturing of sterile pharmaceutical products

28 October 2014 | By James L. Drinkwater, F Ziel Head of Aseptic Processing Technology/GMP & Chairman of Pharmaceutical and Healthcare Sciences Society

Control strategies are often implemented when developing drugs and manufacturing biological and therapeutic products, however, increasingly they are considered important in the manufacture of sterile medicines. A control strategy for manufacturing sterile pharmaceutical products and substances sets out a documented approach and rationale taken to control product quality, efficacy and…