Continuous Manufacturing Knowledge Center

The role of digital twins in driving sustainability

0.0 out of 5 stars

29 Oct 2024 | Peer-reviewed journal | Contributor(s): Deborah McElhone, Barrie Cassey, Kamal Abu-Hassan

As the pharmaceutical sector endeavours to become more sustainable, we hear how digital twins – virtual replicas of systems or products that can help predict performance – are supporting the industry in its efforts.

Continuous Processing. Continuous Evolution

0.0 out of 5 stars

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 manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector

0.0 out of 5 stars

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

The author explains how continuous manufacturing is reshaping pharmaceutical production

Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR

0.0 out of 5 stars

16 Sep 2024 | Website | Contributor(s): Richard Steiner

In pharmaceutical continuous manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity and unit dose exist for online, in-line, and at-line measurements. Process analytical technology (PAT) allows in-line measurement and control of critical process...

The Rise of Continuous Manufacturing in Pharma

0.0 out of 5 stars

13 Aug 2024 | Website | Contributor(s): Editorial Team

"Mr Indu Bhushan, CEO and Director of STEERLife shares his insights on the transformative journey of continuous manufacturing, and the advanced technologies that have propelled this paradigm shift. He also throws light on how continuous manufacturing has accelerated drug development...

Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing

0.0 out of 5 stars

13 Aug 2024 | Peer-reviewed journal | Contributor(s): Sara Fathollahi, Pauline H. M. Janssen, Bastiaan H. J. Dickhoff, Henderik W. Frijlink

The pharmaceutical industry is gradually changing batch-wise manufacturing processes to continuous manufacturing processes, due to the advantages it has to offer. The final product quality and process efficiency of continuous manufacturing processes is among others impacted by the properties of...

Critical review on the role of excipient properties in pharmaceutical powder-to-tablet continuous manufacturing

0.0 out of 5 stars

13 Aug 2024 | Peer-reviewed journal | Contributor(s): Sara Fathollahi, Pauline H. M. Janssen, Bastiaan H. J. Dickhoff, Henderik W. Frijlink

The pharmaceutical industry is gradually changing batch-wise manufacturing processes to continuous manufacturing processes, due to the advantages it has to offer. The final product quality and process efficiency of continuous manufacturing processes is among others impacted by the properties of...

Process intensification of pharmaceutical powder blending at commercial throughputs by utilizing semi-continuous mini-blending

0.0 out of 5 stars

13 Aug 2024 | Peer-reviewed journal | Contributor(s): Maarten Jaspers, Florian Tegel, Timo P. Roelofs, Fabian Starsich, Yunfei Li Song, Bernhard Meir, Richard Elkes, Bastiaan H.J. Dickhoff

Process intensification involves the miniaturization of equipment while retaining process throughput and performance. The pharmaceutical industry can benefit from this approach especially during drug product development, where the availability of active pharmaceutical ingredients (API) is often...

Continuous Manufacturing in the Pharmaceutical Industry: Enhancing Drug Production

0.0 out of 5 stars

23 Jul 2024 | Website | Contributor(s): Timmerman, Siebe

A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch processing, CM operates continuously. This method potentially offers increased efficiency, agility, and flexibility in the manufacturing of drug...

Blend uniformity monitoring in a continuous manufacturing mixing process for a low-dosage formulation using a stream sampler and near infrared spectroscopy

0.0 out of 5 stars

19 Jul 2024 | Peer-reviewed journal | Contributor(s): Rodolfo Romanach, Raúl S. Rangel-Gil, Juan M. Nasrala-Álvarez, Rafael Méndez

Continuous manufacturing has the potential to offer several benefits for the production of oral solid dosage forms, including reduced costs, low-scale equipment, and the application of process analytical technology (PAT) for real-time process control. This study focuses on the implementation of...

Control oriented modeling of twin-screw granulation in the ConsiGmaTM-25 production plant

0.0 out of 5 stars

09 Jul 2024 | Peer-reviewed journal | Contributor(s): Johannes Khinast, Martin Horn, Jakob Rehrl, Selma Celikovic, Johannes Poms

ConsiGmaTM-25 is a continuous production plant integrating a twin-screw granulation, fluid bed drying, granule conditioning, and a tableting unit. The particle size distribution (PSD), active pharmaceutical ingredient (API) content, and liquid content of wet granules after twin-screw...

Implementation of a fully integrated continuous manufacturing line for direct compression and coating at a commercial pharmaceutical facility – Part 1: Operational considerations and control strategy

0.0 out of 5 stars

25 Jun 2024 | Peer-reviewed journal | Contributor(s): Conway, Stephen L., Rosas, Juan G., Overton, Paul, Tugby, Neil, Cryan, Phillip, Witulski, Frank, Hurley, Samantha, Wareham, Laura, Tantuccio, Anthony, Ramasamy, Manoharan, Lalloo, Anita, Gibbs, Mason, Meyer, Robert F.

We implement a fully integrated continuous manufacturing (CM) line for direct compression and coating of a pharmaceutical oral solid dosage form in a commercial production facility. In this first paper of a two-part series, we describe process design and operational choices made to introduce CM...

Implementation of a fully integrated CM direct compression and coating process at a commercial pharmaceutical facility - Part 2: PAT and RTD results for normal operational conditions batches.

0.0 out of 5 stars

25 Jun 2024 | Peer-reviewed journal | Contributor(s): Rosas, JG, Brush, P, Thompson, B, Miller, C, Overton, P, Tugby, N, Stoliarskaia, D, Hurley, S, Ramasamy, M, Conway, SL

This is the second of two articles detailing the continuous manufacturing (CM) development and implementation activities for an marketed product which have been realized in novel, qualified equipment, using validated control strategy elements to enable manufacture of batches under current good...

Development and Application of Control Concepts for Twin-Screw Wet Granulation in the ConsiGmaTM-25: Part 2 Granule Size

0.0 out of 5 stars

04 Jun 2024 | Peer-reviewed journal | Contributor(s): Selma Celikovic, Johannes Poms, Johannes Khinast, Martin Horn, Jakob Rehrl

Traditional operation modes, such as running the production processes at constant process settings or within a narrow design space, do not fully exploit the advantages of continuous pharmaceutical manufacturing. Integrating Quality by Control (QbC) algorithms as a standard component of...

Embracing continuous manufacturing in the pharmaceutical industry

0.0 out of 5 stars

03 Jun 2024 | Website | Contributor(s): Joelle Anselmo

"Drugmakers have been slow to adopt the production process, which experts say can streamline operations, boost data quality and reduce time to market."

Embracing continuous manufacturing in the pharmaceutical industry

0.0 out of 5 stars

03 Jun 2024 | Website | Contributor(s): Joelle Anselmo

"Drugmakers have been slow to adopt the production process, which experts say can streamline operations, boost data quality and reduce time to market."

A Focused and Flexible Analytical Strategy is Key to Unlocking the Benefits of Continuous Manufacturing

0.0 out of 5 stars

11 Apr 2024 | Website | Contributor(s): Bikash Chatterjee

Continuous manufacturing processes promise shorter manufacturing cycle times without the need for intermediate storage, sampling testing and release of intermediate process steps, and shorter product release times through the intelligent application of in-line and at-line testing strategies....

Innovation and Continuous Improvement in Pharmaceutical Manufacturing

0.0 out of 5 stars

28 Mar 2024 | Document | Contributor(s): Ajaz Hussain (Chairperson) Raafat Fahmy (CVM), William Bargo (CVM), Robert Coleman, Robert (ORA), Elise Murphy (ORA), Frank Holcombe Jr (CDER), Chris Watts (CDER), See Lam (CDER), Jon Clark (CDER), Christopher Joneckis (CBER), John Dietrick (CDER), Diana Kolaitis (ORA), Vilayat Sayeed (CDER), Mai Huynh (CVM), Norman Schmuff (CDER), Andrew Chang (CBER)

The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century

Innovation and Continuous Improvement in Pharmaceutical Manufacturing

0.0 out of 5 stars

28 Mar 2024 | Document | Contributor(s): Ajaz Hussain (Chairperson) Raafat Fahmy (CVM), William Bargo (CVM), Robert Coleman, Robert (ORA), Elise Murphy (ORA), Frank Holcombe Jr (CDER), Chris Watts (CDER), See Lam (CDER), Jon Clark (CDER), Christopher Joneckis (CBER), John Dietrick (CDER), Diana Kolaitis (ORA), Vilayat Sayeed (CDER), Mai Huynh (CVM), Norman Schmuff (CDER), Andrew Chang (CBER)

The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century

A Perspective on Quality by Design: A Preclinical Opportunity

0.0 out of 5 stars