Interesting Guest post by Fernando Sanchez, see his blog here Life Mirror. Title image, Chris Edlin pictured on right handside.

The issue of sanitation and sterilization of facilities manufacturing pharmaceutical products is seldom featured on fancy magazine articles or specialist pieces. It perhaps lacks the glamour and buzz surrounding molecule development or the advent of a brand new remedy for a given ailment.

Nevertheless, neither one of those achievements would be possible without a thorough and efficient cleaning protocol to ensure that the final products and chemicals are sterile and pathogen free. Cleaning of equipment in a clinical environment can pose a significant challenge, one that must be thoroughly overcome during the manufacturing process. Otherwise, lives could be at risk.

The Pharmaceutical Manufacturing Technology Centre (PMTC) is an Irish organisation headquartered within the grounds of the University of Limerick campus in Castletroy, Limerick. Founded in 2013 and led by Dr. Chris Edlin, the Centre’s director, the PMTC focuses on the innovation of cleaning technologies and processes to enhance and advance Ireland-based biopharmaceutical firms.

An insight into PMTC

I recently had the opportunity to attend the 3rd annual PMTC Knowledge Day, hosted at the University of Limerick.

The beautifully landscaped grounds provided a comfortable and pleasant backdrop for the event, which gathered a lot of industry leaders and academics addressing cleaning and Process Analytical Technology (PAT) issues. The day also included insightful lightning talk sessions detailing PMTC core funded projects, partner companies, and funded collaborative opportunities. It was a chance for networking, and to delve further into a world seldom seen outside specialized industry circles.

PMTC’s Centre Director, Chris Edlin, kindly shared 30 minutes of his time with me, so we engaged in an information sharing session, where Chris candidly spoke about PMTC’s present, future, and key priorities. Here’s what he had to say.

What are PMTC’s business priorities, both at present time and going forward?

One of the PMTC’s main focus areas is innovation in the field of cleaning technology, and the creation of cleaning innovation programmes for the pharmaceutical manufacturing industry. Additionally, we have programs researching the enabling of continuous processing, powder processing, and the development of soft sensors. PMTC aims to create an environment to support all manufacturing challenges.

Please talk a bit about PMTC’s core research programs.

Currently, PMTC focuses on six core research programs. These are:

Advanced rapid micro-analytical techniques – Handheld devices to fast detect and identification of microbacterial load. This is currently in commercialisation phase.

Enabling and control of continuous processing – Blending, granulation, drying, extrusion, RC (Roller Compaction), Extrusion, Tableting. The current focus is in Oral Solid Dosage (OSD).

Soft sensor modelling tools – This encompasses tool generation for quality, information processing, and signal control.

Chemometrics – Data analysis based on results obtained from calculations on measurements of chemical data

Powder processing – Mathematical treatment of powder compaction.

Cleaning, validation, and verification – Novel instrumental approaches, including mathematical and methodological approaches to verify sterilization.

Given the needs of emerging markets in terms of pharmaceutical requirements, how do you see PMTC expanding to cater for such requirements?

At a global level, manufacturing facilities must become flexible. Emerging markets pose unique challenges that require flexible approaches to achieve patient benefits. To achieve these desired outcomes, medicine is becoming personalised and stratified, which will require a paradigm shift in manufacturing.

Internally, PMTC utilises mathematical models to determine endpoints. Essentially, we develop interfaces and testing facilities to replicate manufacturing environments. This enables us to create a practical approach to a solution.

Does PMTC receive State funding?

Yes, Enterprise Ireland recently awarded PMTC €1.3M for cleaning research. This funding will be primarily used on researching and improving cleaning processes in the pharmaceutical manufacturing industry.

Is PMTC primarily focused on the local or international market?

PMTC focused on the national market for the last three years. The chief reason is that Ireland has become a prime hub for the manufacturing of biopharmaceutical products, hence it made good business sense to focus on local markets at the beginning. However, PMTC is currently expanding into international markets.

Could you give us an example of where PMTC made a crucial difference to a project?

Absolutely. The case that springs to mind is some work we did with a multi national pharmaceutical company in Cork. We helped developed a new way to approach their cleaning procedures, which was implemented and led to a 10% reduction in resource utilisation during the cleaning cycles.  This had a significant and tangible benefit in releasing plant capacity and also in reducing costs significantly for our partner.

The Mystery of The Buzzer, the Doomsday Radio Station Broadcasting from Deep Within Russian Territory, by Fernando Sanchez

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