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News / May 06, 2021

Science Turnaround - Case Studies

Case Studies presented by our scientists: how alternative scenarios accelerated progress and improved results allowing our clients’ products to perform better.

Science Turnaround - Case Studies | Hovione

Welcome to the new “Science Turnaround” Series

Our multinational team partners with global customers to help deliver lifesaving and life changing medicines for patients all over the world. Most of the projects we are involved in are complex and challenge us to innovate in order to allow our clients’ products to perform better. 

In this new compilation of Case Studies presented by our scientists, we share how Hovione’s multi-disciplinary teams’ expertise, scientific rigor and out-of-the-box thinking allowed us to see alternative scenarios, accelerating progress and improving results.

 

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Case Study - Enabling lean manufacturing with Process Analytical Technologies (PAT) | Hovione

 

Case Study #6 - “Enabling lean manufacturing with Process Analytical Technologies (PAT)"

In this case study, Ricardo Sousa explains how a 20h bottleneck was eliminated by replacing a loss on drying method with NIR, decreasing the stocking time to 5 hours.

Case Study - De-risking scale-up of DPI formulations | Hovione

 

Case Study #5 - “De-risking scale-up of DPI formulations”

In this case study, João Pereira and Beatriz Fernandes explain how to approach the scale-up of DPI formulations from lab to commercial scale by maintaining scale-independent blending parameters and the capsule filling mechanism, avoiding impact on processability and final product performance. 

Case Study - Hazardous Chemistry at High Temperature | Hovione

 

Case Study #4 - “Hazardous Chemistry at High Temperature”

In this case study, Rudi Oliveira explains how a hazardous chemical process was approached and how continuous flow was applied to achieve a safer and more efficient process at scale.

Case Study - Understanding crystallization | Hovione

 

Case Study #3 - "Understanding crystallization"

In this case study, Filipe Vultos and Liliana Silva explain the approach taken to study the physical stability of a multicomponent amorphous solid dispersion formulation with the aim of achieving a better understanding of the crystallization events occurring during stability studies.

Case Study - Reduction of QC burden | Hovione

 

Case Study #2 - "Reduction of QC burden"

In this case study, André Cruz explains how an analytical bottleneck, that resulted from a combination of a time-consuming analytical technique with a process that involved high throughput of samples, was approached and how Chemometrics allied with Near infrared (NIR) spectroscopy were applied to achieve a faster analytical response that potentiate the increase of productivity for both QC and Production areas.

Case Study - In water we go | Hovione

 

Case Study #1 - “In water we go”

In the first case study, Susana Lucas explains how a multistep chemical process was approached toward a new synthetic route to achieve an efficient and highly sustainable one-pot scalable process.

 

 

 

Wondering if your projects can achieve better results this year?

 

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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Continuous Tableting and the Road to Global Adoption

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