innopharma quarter one newsletter 2020


 


 

Numbers

Updates from the Technology Division 

SmartX Updates

In December we commenced a research project with the DPTC using our SmartX intelligent manufacturing platform. The work demonstrates the utility of SmartX outside of Pharma. It will focus on optimising process conditions during spray drying to improve flowability of milk powder (currently a challenge in the industry for conveyance and product performance) by optimising process conditions during spray drying and will continue with the DPTC into 2020.

In December 2019, the software development team completed the last major aspect of SmartX software which is FDA

 21 CFR Part 11. SmartX software is now ready with technical control for its first test implementation journey.






PAT Update

Innopharma Technology has made some milestone achievements and improvements to PAT Technology. In the new year, Eyecon2 received ATEX 2/22 certification for use in the explosive environment and ROHS 3 environmental Compliance. Also, shipped the first Eyecon2 unit with Autostage.

Eyecon2 now ensures fully automated benchtop analysis with the development of Autostage. Released in December, the robotic stage eliminated manual adjustment of sample disk. It can now be used both in inline and benchtop processes without an operator. Innopharma Technology has also released a new Verification Standard Kit based on certified laser pinhole technology for Eyecon2.

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Marketing and Events:

The marketing team launched the new technology website www.innopharmatechnology.com on October 30, followed by the creation of dedicated social media channels. The migration from the old site took around three months and currently enjoys better messaging and user experience. 

A happy moment to announce, the first SmartX application note on “Self-guided Control of a Fluid Bed Granulation Process” will be published by Pharmaceutical Technology Magazine in their January 2020 edition. An excellent opportunity for Innopharma Technology to showcase the smart control technology for fluid bed granulation. 

In November 2019, our Head of Engineering supported Glatt Air Techniques at a training seminar that GAT was hosting at their development centre in New Jersey for the local Industry. It was an excellent opportunity to meet with North American customers and showcase the use of Eyecon for endpoint detection in novel processes such as Glatt CPS® Technology (Complex Perfect Spheres) based on fluid bed rotor technology.

In November 2019, our continuous manufacturing experts attended the Pharma 4.0 Conference organised by ISPE in Old Trafford Stadium, Manchester. ISPE provided a platform to connect with fellow Pharma 4.0 though leaders and gain insight from the industry.

Innopharma Technology at ISPE

Analytical lab/Crystallisation:

Our last newsletter stated constructing a new Analytical/Crystallization lab for Validation training as well as SmartCrys Project. We are happy to share the lab is now ready and under operation where QC training is currently undergoing.

Analytical Lab

Make sure to check out the News section on our Education & Technology website for regular updates 

 

Exciting News from the Education Division 

Our January 2020 Springboard programmes have all kicked off, reaching our highest number of Springboard Applicants to date. In the last two intakes, we have over 850 students studying with us across Dublin, Cork, Limerick and also Waterford, Galway and Athlone for our Certificate in Pharmaceutical & Medical Device Operations. 

It was an another busy few months leading up to our January intake with numerous Open Evenings, Drop-in Session, Events, Webinars and Interviews to get our students on board. 

The Cork Jobs Expo took place in November where Ann Mitchell and Fiona attended on behalf of the Education & Validation divisions. It was a great successful day with lots of interest. We also attended the Galway Jobs expo which was another busy day!



Pharma Awards 2019

The Pharma Awards 2019 took place in October. Our ‘MSc in Pharmaceutical Business & Technology’ was shortlisted for the ‘Pharma Education & Training’ Awards and we also sponsored the ‘Partnership Alliance of the year’ award which was won by Pfizer Ringaskiddy & Indaver’. Although we didn’t win this year, it was a great night!

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Innopharma application to QQI for Initial Access to Validation

QQI (Quality and Qualifications Ireland) is an independent State agency responsible for promoting quality and accountability in education and training services in Ireland. The role of QQI is to promote, maintain and develop the Irish National Framework of Qualifications (NFQ), a 10-level framework for the development, recognition and awarding of qualifications in Ireland.

Providers without an existing relationship with QQI who wish to offer QQI approved programme must first apply for initial access to validation. In December 2019 a submission was made for this initial validation by Innopharma which would allow us to become an education provider of QQI approved programmes.

What does the application to QQI involve?

To submit an application to QQI, Innopharma have developed it’s own Quality Assurance Handbook along with a handbook of supporting policies and procedures. The application involved completing a gap analysis or our Quality policies & procedures against the QQI requirements. Our experience of developing and delivering programmes with our collaborative partners TUD, Tallaght Campus and Griffith College Dublin have provided us with years of experience working and complying with their quality policies and procedures which we will continue to do into the future.

Next steps with our application is to facilitate a panel review, which is expected in early March. QQI will appoint the panel of reviewers who will conduct an audit of our policies and procedures and make a determination on whether or not we meet the required standard to become a QQI provider of education.

 If you would like further information on this topic please don’t hesitate to reach out to Finbarr Sheehy, Orla Callan or Sandra Mooney

Watch this space for further updates!

 







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International Students





International Students 

We had great success with our International Students, where we had the highest number of individuals studying with us to date. They came from various countries all around the world such as India, Brazil, Turkey, Nigeria & Philippines. It is great to see our brand being recognised globally. We are working hard transitioning them into roles in the industry and have many successes to date. 


Graduations 

The Griffith College Graduations took place in November in Dublin & Cork. It was great to see such a high number of graduates from the Innopharma faculty and to receive such positive feedback from them all and we wish them all the best in their future careers. We got great content from the day too!

The TU Dublin – Tallaght campus graduation also took place. We had a number of students from our Pharma, Medtech and Food Science programmes graduating. It was another great day.


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Joining the Education Team 

A very warm welcome to Alexandra Anton who joined the education team last week. Alexandra completed our Certificate in Food Science and Technology programme last year. She also has a BA in Psychology from Waterford IT and an MSc in Psychological Science from University Limerick. She will be working with the team focusing on student experience & outcomes.

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Innoskills Updates 

Our Innoskills platform is continuing to grow, as we have over 500 students registered, including 100 pharmacy students from Trinity College Faculty of Pharmacy. Here is a break-down of all the modules that have been completed. 

Module

Completed

Introduction to Pharma Utilities, Facilities, HVACs and Cleanrooms

226

Bioprocessing

56

Clinical Research

14

Quality Assurance and Good Manufacturing Practice

171

Process Analytical Technologies

141

Overview of Tablet and Capsule Manufacturing and Packaging Processes

56

Validation

105

Medical Devices

6

 

More News from Technical Services

Quality Control Analyst Programme

We are delighted to announce that our QC Analyst programmed, which is based on our very successful Validation model, has kicked off.  Our QC laboratory has been fitted out with the capabilities of carrying out all finished product release testing for OSD formulations.  Our instrumentation includes a Waters Alliance HLPC with Empower 5 software, Pharmatech Dissolution bath, Syrris Reactor, Dr Schleuniger Hardness tester, Sotax Friabilator, as well as a number of analytical balances.  The programme itself is aimed at science graduates and provides hands-on experience of all aspects of finished product release testing, including:

  • Sample Management life cycle/chain of custody
  • QC testing requirements & Good Laboratory Practices
  • Laboratory Quality Management Systems
  • QC laboratory Documentation
  • Analytical Test Methods & Validation
  • Analytical Instrumentation, HPLC, Dissolution, etc and chemical testing requirements
  • System suitability, calibration & maintenance,
  • Sample analysis, Results and reporting, Troubleshooting, Laboratory investigations, Trending




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irene

We welcome Irene Nowak who has come on board as our QC programme Manager (see bio below). Irene has been instrumental in both the setup and delivery of the programme.  Our first Cohort of analysts have been recruited and are currently busy training with Irene.  Placements of our QC Analysts in the industry will commence in February. 

Irene Nowak

Irene has over 10 years of industrial experience having worked in Boston Scientific, Allergan, Sigmoid and BMS. Her roles included QC Chemist, R&D chemist and QC Supervisor. She has been responsible for analytical method development, method validation and tech transfer of analytical methods. Irene has trained analysts and driven improvements in the lab CAPA system. She has managed all aspects of testing from raw materials through to the finished product, stability samples, validation samples and water samples. Most recently Irene was involved in the Qualification of Lab equipment for a Biopharma Start-Up. Irene holds an MSc in Organic Chemistry from DCU.

Meet Our New Starters

Find out more

Stephen O'Brien 

Stephen is both a qualified Mechanical Engineer (University of Limerick) and Pharmacist (Trinity College Dublin). During his education Stephen had placements in both Pfizer in Cork and GSK in Waterford in Projects and NPI roles. Stephen has also spent time as a pharmacy intern in a number of hospitals and has also spent some time in a retail pharmacy.

Stacey Carmody

Stacey holds a BSc in Biochemistry from UCC. Stacey spent the early part of her career in research and later as a Technical Development Analyst in the laboratories at Mylan. More recently she held various Management positions with Medserve, a provider of medical billing services to consultants, consultant groups and hospitals throughout Ireland and the UK.

Suvriti Bali 

Suvriti holds a Bachelor of Technology (BTech) from Jaypee Institute of Technology in Delhi and a Masters of Science (MSc Business Strategy from UCD Smurfit Business School. Suvriti recently completed our validation programme with Cohort 10. 

Julianna Lopes

Juliana holds a Bachelor's in Pharmaceutical Science from Rio de Janeiro Federal University in Brazil. Julianna spent the early part of her career in research. She then spent the last 5 years in Validation, Engineering roles, initially with Daudt Oliveira Group, Megapharma and subsequently Merck South America, gaining experience in equipment, process and cleaning validation activities

Pedro De Sousa Albuquerque 

Pedro is a qualified Mechanical Engineer from Federal University of Minas Gerais, Brazil. Before relocating to Ireland, he spent a number of years in Aeronautical industry with Embraer. Pedro was involved in the development stage of many components in the KC 390 aircraft, which is a medium-weight military transport jet.

Pharma 4.0

New Starters

It’s been a busy few months with our Validation group and we welcome Stephen O’Brien, Juliana Lopez, Pedro de Sousa, Stacey Carmody and Suvriti Bali to our team.  Stephen, Stacey and Suvriti have joined Regeneron, in Limerick in support of their cleaning validation programme. They join Meabh McGuinness and Katy Wrynn at Regeneron.  Juliana has joined Lilly in Cork in support of their C&Q activities, joining David Thomas and Catherine McAlorum.  Pedro has joined Boston Scientific in Cork supporting their process development projects.

People on the move

After 2 years in Sanofi, Catherine McAlorum has moved to Lilly supporting their cleaning validation programme.  Noreen Hanrahan has moved from Regeneron to Janssen.  Noreen is supporting Janssens CV programme and is our first Validation Engineer on that site.

We bade farewell to Ed Foan, John Melia and Tim Hawkins.  Ed from cohort 1 had spent over 2.5 years supporting Pfizer, Grangecastle’s temperature mapping programme.  John was instrumental in the CV start-up activities in BMS and Tim supported the project at Boston Scientific, Cork.  We wish Ed, John and Tim best wishes for the future.

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Pharma 4.0 Event 

We wrapped up the final quarter of the year with our successful Pharma 4.0 event. This was a fantastic success and we have positioned ourselves as thought leaders of Industry 4.0. The day started with our Morning seminar at the Alex Hotel, Where MC Aidan McCullen welcomed everyone and Ian gave an introduction of the day. Ian spoke about industry 4.0 and how it will affect the Pharma Industry and where Innopharma fits into that. 

Mary Mitchell O’Connor delivered the opening address where she acknowledged the key higher education institutes and the work that they’ve done to upskill and reskill people into the Pharma industry. She then highlighted the opportunities afforded by the fourth industrial revolution and how the BioPharma industry can prepare for that.

Following on, Matt Moran highlighted that we must manage and maintain what we currently have, which is a strong Biopharmaceutical Manufacturing sector. The strength of the skills and talent in the country needs to be carefully managed and expanded on while moving into the future. He concluded with, the key to all of this is the ability for people to stay collaborative and innovative. 

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Afternoon Event 

Over 100 people came along to the afternoon session where we brought together such an amazing group of industry leaders and speakers, alongside BioPharmaChem Ireland to discuss the key challenges and opportunities with the future of the BioPharma Industry.
 
The afternoon consisted of four very insightful presentations. Henrik Von Scheel gave a fantastic keynote presentation on the 4th industrial revolution concerning the BioPharma industry. John O'Doherty, Enterprise Director at Microsoft gave some of his thoughts on how Microsoft thinks about Digital transformation in the Pharmaceutical industry. Next Aidan McCullen spoke about the themes of digital transformation, artificial intelligence and innovation & mindset. To end the day, Finbarr Sheehy addressed the future skills and competencies in a digital age specific to the pharma and high-tech manufacturing industry.


All these interesting presentations can be found here, definitely worth a watch. 



We then welcomed our keynote speaker to the floor, Henrik Von Scheel, best known as the originator of Industry 4.0 and mastermind of the digital theme of today. He gave an engaging, exciting and informative talk on the topic relating to the Pharma Industry. 

The 4th industrial revolution will fundamentally alter the way we live, work, our economy and how we relate to one another. In its scale, scope, and complexity, the disruption is unlike anything humankind has experienced before. It is disrupting every industry and economy in every country. 

Biopharma 4.0 delivers unparalleled opportunities for growth and productivity, it resets the competitive landscape and redefines smart factory, products, service model and creates the next generation of operational excellence of automation, connectivity and alignment across the value chain. 

Henrik's talk led us into our group break out sessions, where each table discussed in depth their allocated question. 

We had a great panel discussion to end the day with Dr Vivienne Patterson, Orla Callan, Erik O'Donovan and David C Heagarty, all giving their views and opinions through the Q&A session. If you missed the morning session you can check out what you missed by clicking here. 

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