NecstGen Joins Major New Collaboration Project to Create Biointelligent Sensor for Improved Biomanufacturing

As part of the Horizon Europe framework, NecstGen has joined an international consortium, that will work to develop Biointelligent Sensors for real time in production measurement and control of therapeutics including Cell and Gene Therapies. The biohybrid sensor technology will help optimise biomanufacturing and so deliver exciting new technology. It is funded with over 6 million euros as part of the European HORIZON programme, started on 1 July 2022, and will run for 48 months.

NecstGen joins as an organisation with expertise in the development and manufacturing of Cell and Gene Therapies. A fundamental and key part of delivering the safe and efficacious therapeutics of tomorrow is to understand how the systems and processes to manufacture them are performing. In the project NecstGen will work to develop an example manufacturing system on which new technologies can be developed and tested.

The convergence of technical, informational, and biological systems are the basis of biointelligence. This new paradigm opens up a huge innovation space globally. Because Europe is at the forefront of manufacturing excellence, BioProS will make a significant contribution to sustainable and resilient manufacturing processes in the EU. Digital and bio-based process chains have the potential to revolutionise many industries and ensure their competitiveness.

The goal of BioProS is to optimise the production processes for therapeutic viruses through better quality control. A biohybrid sensor technology monitors cell-based virus infection cycles in real time. For this purpose, optical sensor technology is combined with cell-based measurement principles. Within BioProS, a platform technology is being developed that can be adapted to several specific substances and virus types. This allows applying it in different industries and production environments. Since such a platform technology is complex, numerous European partners from different disciplines such as biology, engineering and mechanical engineering or computer science are involved.

Seven partners from five countries are represented in the BioProS consortium: BICO Group AB, Sweden, NecstGen, the Netherlands, Fraunhofer (IPA and IGB), Germany, Eberhard Karls Universität Tübingen, Germany, EurA AG, Germany, ElveSys, France and Politenico di Milano, Italy. The consortium gathers all the necessary expertise under its roof and forms the basis for international partnerships. In close cooperation with other European initiatives and with the support of an industrial advisory board, the project partners want to realise the vision of biointelligent manufacturing and demonstrate the applicability of disruptive technologies in an industrial setting. This will foster research for biointelligent methods and global applications while guaranteeing technological sovereignty for Europe in the long term.

This project has received funding from the European Union’s Horizon Europe research and innovation programme (HORIZON-CL4-2021-DIGITAL-EMERGING-01-27: Development of technologies/devices for bio-intelligent manufacturing (RIA)) under grant agreement No 101070120.

NecstGen announces the opening of its Cell and Gene Therapy Manufacturing and Development facility.

On 1 June 2022, NecstGen’s brand-new GMP manufacturing and development facility for cell and gene therapies has been opened by Henri Lenferink (Mayor of Leiden), in the attendance of Paul Bilars (CEO of NecstGen), Focco Vijselaar (Director General for Enterprise and Innovation at the Ministry of Economic Affairs and Climate Policy), and Pancras Hogendoorn (Dean of the Leiden University Medical Center), as well as representatives from the Province South Holland, RegMed XB, Leiden Bio Science Park and University Leiden. 

During the festive opening event, visitors were able to get a glimpse of the highly controlled cleanrooms, laboratories, and equipment, which will be in full operation soon. NecstGen’s 4,000 m2 facility features 13 cleanrooms and 3 development laboratories supported by labs for quality control, and office space. Here, cell and gene therapy developers from all over the world can develop and produce a next generation of therapies. 

Construction was only started in April 2021 in the right wing of the Mirai House at the Leiden Bio Science Park. In following months, the facility will be furnished and qualified for the release of GMP products. 

Paul Bilars commented “We are excited to contribute to a new era in medicine. With the opening of our new facility, we hope to take an important step in setting up a future-proof healthcare infrastructure that can benefit from the developments in cell and gene therapy. Ultimately, this helps us to get a new generation of therapies faster to the patient.”

About NecstGen

NecstGen is a new centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park. Here, NecstGen provides critical contract development, manufacturing, and rental services to academic and industrial therapy developers to deliver a new generation of therapies to patients. NecstGen is fully owned by the Leiden University Medical Center and has also obtained support from the National Growth Fund, Province South Holland, and Leiden University.

Leiden, Netherlands, April 26, 2022 – ProteoNic, a leading provider of premium vector technology and services for efficient production of biologics, and NecstGen, a CDMO and centre of excellence for Cell and Gene Therapy, announce a partnership for the development of improved viral vector manufacturing for gene therapy applications. Both companies, located on the Leiden Bio Science Park, recognise the need to increase viral titres and optimise production processes. Cost-efficiency and manufacturing yield play a critical role in the feasibility of vector-based therapies. Through their combined efforts ProteoNic and NecstGen aim to improve and advance AAV and LV viral vector manufacturing technology and increase production capacity, to the ultimate benefit of patients in need of Gene Therapies.

ProteoNic will apply its established 2G UNic™ technology platform to improve viral vector performance. NecstGen, specialised in the manufacturing and development of various viral vector types, contributes its viral vector platforms, manufacturing processes and experts as part of this partnership. Ultimately the companies strive for the acceleration of novel Gene Therapies by removing existing road blocks related to production efficiency and capacity.

Frank Pieper, CEO of ProteoNic commented “ProteoNic has a strong track record of improving vector performance and production levels in a range of applications. We believe that together with NecstGen we can improve the production efficiency of viral vectors for Gene Therapy, and thereby alleviate current manufacturing constraints”.

Paul Bilars CEO, NecstGen said “This action shows the strength and importance of the local ecosystem, and how working together we can address the challenges of Gene Therapy development and their translation to solutions for patients and society”.

About ProteoNic

ProteoNic is a privately held company with offices in Leiden, the Netherlands and in the Boston area, USA. The company offers technology and services for the generation of cell lines with greatly improved production characteristics, including production levels and stability. The company commercializes its proprietary 2G UNic™ technology through licensing and partnership arrangements. For more information, see www.proteonic.nl.

About NecstGen

NecstGen is a new centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park. Here, NecstGen provides critical contract development, manufacturing and rental services to academic and small/large industrial therapy developers to deliver a new generation of therapies to patients. For more information visit www.necstgen.com.

For more information please contact:

ProteoNic

Mark Posno, PhD

Vice President Business Development

T: +1 617 480 8016

E: posno@proteonic.nl

NecstGen

Tristan Pritchard-Meaker, PhD

Head of Business Development

E: tristan@necstgen.com

Today, the Novo Nordisk Foundation announced the € 300 million funding of an international consortium including Leiden University Medical Center, the Danstem Institute at the University of Copenhagen and the Murdoch Childrens Research Institute in Melbourne to bring stem cell-based therapies from the laboratory to the patient.

NecstGen collaborates in this consortium as development and manufacturing partner to help advance cell and gene therapies through clinical development.

During a 10-year period, the consortium will focus on tissue reconstruction, clinical application of stem cells, and genetic modification techniques.