Mission

The vision of the PMTC is to make Ireland the global hub of pharmaceutical process innovation and advanced manufacturing through applied research into advanced technology solutions:

• Improving Pharmaceutical Manufacturing Competitiveness
• Enhancing the R&D Mandate of Irish Pharmaceutical Manufacturing Sites

The PMTC will develop a reputation as a world class centre of excellence for Pharmaceutical manufacturing issues, with the ability to attract significant future R&D funding from both industrial and EU/National funding agencies.

Research Programme

Currently there are 6 main themes of research in PMTC. These are:

Advanced rapid micro-analytical techniques

The rapid microanlytical techniques project is a collaboration between the MiCRA (hyperlink) centre in IT Tallaght and the PMBRC (hyperlink) in WIT. The objectives of this project is to achieve selective separation and electronic detection of micro- organisms using synthetic polymer foot printing. The project is advised by a technical committee represented by Allergan, GSK, Pfizer, Helsinn, Techno-path and Janssen.

Enabling and control of continuous processing

Establish best practice through QbD and PAT initiatives to achieve a consistent quality product from a continuous dry granulation process. The project is advised by a technical committee represented by GSK, Pfizer, Merck, Helsinn, Servier, Gilead and Astellas.

Soft sensor modelling tools

The project aims to mathematically model processes using existing data to provide improved process control and robustness. The projects is advised by a technical committee represented by Pfizer, Allergan, Helsinn, Astellas, GSK and Eli Lilly.

API real time release PAT

The goal of this project is to develop a novel, and robust analytical technology platform for the rapid, in-situ, quantitative analysis of low level contaminants to enable near Real-Time-Release (RTR) during the manufacturing process. To demonstrate this a low cost flexible Liquid Chromatography (LC) platform capable of working within these constraints is being developed. The project is advised by a technical committee represented by Pfizer, Topchem, BMS, Innopharma Labs, Eli Lilly and Allergan.

Powder Processing

The project aims to gain a better understanding of the root cause of powder processing issues and define in line analytical techniques to characterise physical properties and link this to process control strategies at commercial scale. The project is advised by a technical committee represented by Pfizer, Astellas, Alkermes and Takeda.

Cleaning, validation and verification

Cleaning verification and validation has always been a time consuming and costly operation in Pharmaceutical plants. This has become even more problematic in recent years with the focus on decreased inventory thus resulting in more changeovers and more cleaning. PMTC recently initiated a new project call to address the industry wide issues associated with cleaning.

For more details please contact us.

Engagement Models

The main engagement model in PMTC is participation on a PMTC core-funded project. This is where the project is defined by members and funded from the core grant. Industry participants are expected to contribute to the project with market knowledge, specification direction, reviews or benefit-in-kind. Projects are collaborative and often involve multiple industry participants participating in a project. Projects are identified and then follow a rapid 6 step process to a funded outcome.

For PMTC core-funded projects there is a simple industry-designed IP cascade model as shown below which gives members an exclusive right of first sight of the IP. No matter who the research partner for the project is, all exploitation is through PMTC to provide a standardised single point of contact for IP commercialisation. License agreement boilerplate templates are used with standard terms to absolutely minimise licensing overheads and reduce time to market.

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Centre Agreement and IP

For core-funded collaborative projects PMTC operates a predetermined designed IP framework which protects members background IP, rewards project sponsors for their contributions to projects and gives early visibility and right of first sight options to PMTC members on any IP generated.

Additionally, the centre agreement details pre-agreed, preferential IP schedules for other specific project types:

• IP Terms for PMTC Industry/State Multiple Industrial Partner (MIP) Co-funded Project
• IP Terms for PMTC Industry/State Single Industrial Partner (SIP) Co-funded Project
• IP Terms PMTC Industry 100% Funded Project

In addition PMTC members may design their own IP framework in partnership with collaborating research providers for non-core funded projects and may leverage existing off-the-shelf PMTC IP models to accelerate this.

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Member Benefits

PMTC is focused on delivering benefits to both industrial and academic research partners to ultimately create added value to the Irish economy. Some of the benefits for industrial partners include:

• Unrivalled opportunity to direct 100% state funded multi-million euro research projects to ensure relevance to your company needs
• Unrivalled awareness of outputs of these 100% state funded research projects
• Professionally managed and timely access to IP and research outputs at fair market rates
• Pre-agreed, preferential terms to ensure seamless transfer and low transaction cost of core funded research project output in to Industry/state co-funded or 100% industry funded projects with Centre RPO Parties
• Opportunity to influence direction and access output of other 100% State funded programme
• Opportunity to identify talent for future recruitment
• Access to core capability and skills in continuous processing, mathematical modelling, statistics and process optimisation
• Access to members only networking forum and events plus meetings with key industry players, academia, regulators and government agencies