Connect in Pharma 2023

Start

Wednesday, June 14, 2023 - 00:00

End

Thursday, June 15, 2023 - 00:00

Location: Palexpo, Geneva

Hovione presenting at the upcoming “Connect in Pharma” in Geneva.

Connect in Pharma drives innovation, business, and new partnerships in four key areas: Innovative packaging, drug delivery systems, CMO/CDMO, and filling & assembling processes, supporting pioneers in the pharma and biopharma industry. With conferences, workshops and curated networking “Connect in Pharma” offers a platform to drive innovation and solve challenges.

On June 14, José Luís Santos, Director of Technology Intensification will host a session on “The Role of a CDMO in Accelerating the Adoption of Continuous Tableting” and will join a group of experts during a panel discussion on the topic of “Continuous Manufacturing of solid dosage forms: state of the art and future advances”.

Session | The Role of a CDMO in Accelerating the Adoption of Continuous Tableting

Wednesday 14 June, 2:00 PM - 2:30 PM (Theatre 2)

The application of continuous tableting (CT) is steadily developing a foundation in the pharmaceutical industry. Large pharma organizations have been at the forefront of adoption due to their evolving development pipelines that justify the technological disruption. However, systemic application of CT requires more than individually owned installations and can only be achieved with the partnership of the health authorities, equipment vendors, and contract development and manufacturing organizations (CDMOs).

A CDMO role is particularly important for the adoption of emerging technologies such as CT, in that an equipment standard needs to be established where most of the industry can seamlessly integrate with their own development, manufacturing, and supply chains. The processes and knowledge of owning and operating the technology must be broad, yet robust, to assure that the benefits outweigh the perceived risks by a meaningful margin.

This talk will focus on the key areas that require attention for the adoption of CT by the industry, and how at Hovione we are setting ourselves up for successful deployment of the technology.

Panel Discussion | Continuous Manufacturing of solid dosage forms: state of the art and future advances

Wednesday 14 June, 3:30 PM - 4:00 PM (Theatre 2)

We look forward to seeing you in Geneva.

Find out today if Continuous Tableting is right for your product.

Connect with our experts and get to know more about the distinct set of features and advantages that allows going from development to manufacturing in record time with high quality and less variability.

The future is continuous.

Let’s discuss your project together.

Find more about Connect in Pharma.

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

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Connect in Pharma 2023

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