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News / Oct 30, 2019

Hovione’s innovative solutions nominated for CPhI awards 2019

Learn more about the innovations from our scientists

Hovione is nominated for CPhI awards 2019 being shortlisted in two categories:


1. “API Development”, for its PRIME tool - Process Ranking of Inputs from Manufacturing.


CPhI awards 2019 PRIME | Hovione




“It is an honour to have been selected for the finalists’ panel, which is already by itself an achievement. The PRIME tool enables to grow our collective knowledge on chemical processes and being able to visualize how each project is evolving along the lifecycle according to several metrics; additionally, we can establish thresholds for different metrics according to our past knowledge and develop our process to meet those targets. We can also start to build automatically databases for e.g. the most frequent reaction conditions per type of reaction. The tool not only helps managing better our knowledge on chemical processes but also adds a lot of value for our customers” said Filipe Ataíde, PhD, one of Hovione’s scientists responsible for PRIME.


2. “Analysis, Testing, and Quality Control” for its Accelerated dissolution methods for extended release drug product.


Hovione’s innovative solutions nominated for CPhI awards 2019 | Hovione


“Extended release formulations provide many advantages to patients and greatly simplify treatment but carry a heavy burden in terms of quality control. The methodology presented here aims at reducing the burden on the quality control lab, by developing accelerate dissolution methods that shorten the API release duration from several months to a few days. This accelerates the analysis timing and still guarantees the quality of the drug product since a good correlation with the long-term API release is the base of this development. Most importantly, this development poses a very significant advantage in terms of patient compliance, particularly for drugs where administration is complex such as those administered through the ocular route, or when the risk of missing a dose is high, and also regarding drugs with a frequent administration for extended periods. Above all, it contributes to the patients’ well-being” said Mafalda Paiva, MsC, one of Hovione’s scientists responsible for this innovation.



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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  


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