Training voor QC Leiden People Leaders
Driving Results through Individual & Organizational Accountability
Runner-up prize for Leiden Cell Culture Suite 3
Engineering Showcase 2025
Peter Vlasveld (centre) at the 13th edition of the Engineering Showcase in New Brunswick
Batch Release made easy!
Ik ben heel blij dat de Batch RelEASY-applicatie in oktober vorig jaar met succes is gelanceerd. Deze innovatie verbetert de operationele efficiëntie en zorgt ervoor dat de Quality Standards worden nageleefd. Batch RelEASY is een van de eerste applicaties die GxP-rapporten live genereert op het Self-Service Statistical Reporting Platform.
Wat is Batch RelEASY?
Batch RelEASY is een digitale tool voor het maken van rapporten die het genereren van release packages automatiseert en eenvoudiger maakt voor Remicade, Stelara en Simponi (P)FB materiaal op onze Bio sites in Leiden en Cork. Het haalt data op uit onze bronsystemen, zoals SAP, MES, eLIMS, Trackwise en binnenkort Comet, en organiseert deze in rapporten die nodig zijn voor batch release. Het is echter geen transactiesysteem voor batch release. Het registreert geen beslissingen, activiteiten of data. De gegenereerde rapporten vragen om een 'handmatige review stap' op volledigheid, door een QA Officer, voordat een QP ze beoordeelt voor batch release.
De reis – Succes is niet altijd direct een feit, en onze reis was daarop geen uitzondering. In eerste instantie probeerden we Tableau te gebruiken om releaserapporten te genereren, maar dat bleek niet haalbaar. Dit leidde ertoe dat we andere opties onderzochten en uiteindelijk Posit.co kozen als het platform van onze keuze. Posit biedt een betere manier om op R & python gebaseerde oplossingen te implementeren en stelt developers in staat om de open-source tools te gebruiken die ze kennen en waar ze van houden, met het gecentraliseerde beheer, de beveiliging en de ondersteuning die ze nodig hebben.
“De moeite vermindert van uren tot slechts een minuut”
In december 2022 kregen we groen licht van de wereldwijde Digital & Technology Council om Posit voor Batch RelEASY-ontwikkeling aan boord te nemen en te implementeren. Budgetgoedkeuring volgde in april 2023 en we begonnen met de bouw van Batch RelEASY. Het platform werd binnen J&J omgedoopt tot het Self-Service Statistical Reporting Platform (SSSR) en in januari 2024 werd het opgeleverd als een volledig GxP-compliant applicatie. In de zomerperiode hebben we de gebruikersacceptatietests voor Batch RelEASY uitgevoerd en de kwalificatie afgerond. Als eerste gebruiker van dit nieuwe platform werden we geconfronteerd met tal van uitdagingen.
Door gebruik te maken van agile methodologie en het software development life cycle (SDLC) framework werd Batch RelEASY op 29 oktober succesvol gelanceerd op de Bio sites in Leiden en Cork.
Every year an Engineering Showcase is organized by E&PS (Engineering & Property Services). Engineering projects, innovations and a select number of students can apply to be nominated. Based on a poster and a maximum one-minute video, you can be selected and invited to participate in the showcase. This time, the 13th edition of the Engineering Showcase took place in New Brunswick, at the Hyatt Regency hotel next to JNJ headquarters. The Leiden Cell Culture Suite 3 Project team was nominated. I had the honor of traveling to New Brunswick to defend the poster and give a pitch presentation (my one minute of fame!)
More than 200 people were invited as guests, speakers and special guests such as some senior leaders from all regions and sectors. Moreover, the event was broadcast live around the world. I was quite excited to be there! The host of the event was an old acquaintance of ours, namely Nicolette Vink (former MAM lead Leiden). From the home front in Leiden, I received messages that I had done a very nice job, even though I did not say everything I had prepared (nerves took over 😉). All 75 selected pitchers were able to defend their poster in the room next door after the live presentations. There everyone could stop to ask questions, including the judges.
Emotional moment
In the evening a dinner took place during which there were beautiful speeches by Luis Diaz (VP E&PS), Nandita Kamdar (VP Engineering Project delivery) and Cagdas Celik (Global Head Engineering & Technology). The ceremony started with an inspiring video by Kathy Wengel. There was also a special and emotional moment where a patient along with her mother shared her life story about her heart transplant. In doing so, a very innovative product from J&J had saved her life, the Impella Device.
“Like during the one minute of fame, my heart rate soared”
Finalist
Then it was time for the presentation of the awards. The categories for the participating projects were:
- University poster award
- Engineering Building & Infrastructure Achievement award
- 2025 Engineering Innovation award
- 2025 Warren Award
Next, the finalists were called. To my great surprise, I heard my project ended up as a finalist for the Engineering Building & Infrastructure Achievement award! Like during the one minute of fame, my heart rate soared. Then the winner was announced. That was Esteban Rojas from Costa Rica. His project had built a new, huge site where more than 2 million patients are now provided with robust MedTech products. And I was the lucky one to receive the Runner-Up prize for my project.
Hosting the event was none other than Nicolette Vink (former MAM lead Leiden)
Peter during his one minute of fame
Peter with the Runner-Up prize
Everyone gets greetings from Nicolette Vink
Peter defends his poster and answers all questions
Super proud
Full of pride, I returned to my hotel room. After some meet & greets with Cagdas Celik and Nicolette Vink, among others (I had to greet everyone in Leiden 😊), I flew back home the next day. It was a wonderful experience, especially also to see all the developments in the other sectors and sites on Innovation. I am super proud of everyone who contributed to the success of this huge project of Leiden. It was an honor to promote our site as project leader.
Want to know more?
You can find out more about this annual event here in the 2025 report. There will also be a film of the entire event available later on this website.
Peter Vlasveld
Engineering Project Lead MAM-F Leiden
Background Suite 3
In 2023, we embarked on a robust and visionary project that felt like an “open heart operation” for our site, with the ambition to build a brand new 400sqm bioreactor hall, along with an additional DPC space, while maintaining maximum operational capacity in our adjacent production sites. Leila Schwery, VP MTO, officially opened Suite 3, a milestone beautifully captured in this video. In December 2024, the new, impressive Suite 3 went live with 12 state-of-the-art bioreactors, complete with all the necessary facilities and associated equipment. And now, a few months later, we are running at full capacity. This has also impacted the business and patients. Partly because of this, we were awarded prizes at the Engineering Showcase, which is of course successful for Leiden.
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