Press Room

Event

IFPAC 2023

Start
Sunday, June 04, 2023 - 00:00
End
Wednesday, June 07, 2023 - 00:00
Location: Maryland, USA

Hovione is present at the International Forum Process Analytical Technology (IFPAC), a forum that brings the latest trends and real-life applications in the fields of Quality by Design, Process Analytical Technology, Emerging Technologies, Quality Metrics, Continuous Manufacturing and Process Control applications for the pharmaceutical industry, biotechnology, generic, chemical and related industries.

 

HOVIONE PRESENTATIONS

Hovione experts share their knowledge at IFPAC® - 37th International Forum Process Analytical Technology
June 4-7, 2023 | North Bethesda, Maryland (Washington D.C.)

 

June 6: Grand Ballroom G | 4:50 PM - 5:15 PM
Part of session: Recent Developments to Realizing Continuous Manufacturing
Presentation Title: Use of Statistical Process Control to drive process improvements in continuous manufacturing
Primary presenter: Fernando Barros

 

June 7: Grand Ballroom C | 7:50 AM - 12:00 PM
Session: Defining Incentives and Business Cases for PAT - Defining the Boundaries between Batch & Continuous Manufacturing
Chair: Anthony Tantuccio

 

June 7: Glen Echo Conference Room | 11:10 AM - 11:35 AM
Part of session: Enhanced Analytical Approaches & Modeling for Process Optimization
Presentation Title: A template for investigating NIR spectroscopy-based deviations
Primary presenter: Fernando Barros

 

June 7: White Flint Amphitheatre | 1:05 PM - 5:40 PM
Part of session: Continued Process Verification (CPV) - Practices, Challenges and Opportunities
Presentation Title: Enhance Spray Drying CPV using MVDA
Primary presenter: Tiago Porfirio
 

One approach to enhancing Continued process verification (CPV) is through the use of multivariate data analysis (MVDA), which allows for the identification of correlations and patterns between process parameters and product quality attributes. MVDA involves the analysis of multiple variables simultaneously, allowing for a comprehensive understanding of the process and its impact on product quality. By analyzing data from multiple sources, including automated control systems and quality control testing, MVDA can help identify the critical process parameters (CPPs) and critical quality attributes (CQAs) that are most strongly correlated with product quality. This approach can significantly improve process efficiency and product quality while reducing the risk of product failure, reprocessing and rework. Moreover, MVDA provide insights into potential causes for process deviations, facilitating the development of corrective actions. This proactive approach to CPV helps to ensure that the process remains within established control limits, minimizing the risk of non-compliance. This work will show how the integration of MVDA into CPV in a spray drying process can significantly enhance process control and product quality by leveraging multivariate data analysis.
 

 

 

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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  

Article
GMP Journal, 04 March 2024

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024

Hovione Macau was recently awarded the Medal of Merit for Industrial and Commercial Excellence by the Government of Macau, a Special Administrative Region of the People´s Republic of China. This prestigious award recognizes the company's nearly 40 years of outstanding contribution to the pharmaceutical industry in Macau. Eddy Leong, Site Manager of Hovione Macau, accepted this prestigious Medal on behalf of Hovione at the ceremony held in Macau. Eddy Leong expressed his gratitude for the award and emphasized the company's commitment to working with partner organizations to create rewarding career opportunities in life sciences. Read this press release to learn more about the Medal of Merit awarded by Hovione. If you would like to explore our open opportunities in Hovione Macau, please visit our Careers Website.   

News
Exciting News Alert from Hovione in Macau

Hovione Macau awarded by the Government of Macau at a Ceremony held in Macau

Jan 19, 2024

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