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A Quality by Design platform to boost the development of

your innovative products

Quality by Design in 3 minutes

CYBERNANO brings its expertise and platform

 

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to facilitate the implementation of Quality by Design in this project.

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ABOUT

WHAT ? Good Development Practice

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WHY ? Reduce delays and costs, enhance quality, ICH Q8

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WHO ? Start-ups, Biotechs, Medtechs, SME, Big pharma, CDMO

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WHEN ? Throughout the development programs

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HOW ? An integrative platform with all we need to apply QbD

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WHERE ? https://www.easyqbd.eu/
 

For two years, CYBERNANO has got the opportunity

to participate to the European project EXPERT to develop

a new off-the-shelf delivery system for RNA-based nanomedicines

to treat cancer and cardiovascular disease

Why

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You are developing an innovative drug, a medical device or an in vitro test. Unfortunately, there is no innovation without risks: risks for the product to be inefficient, risks to be unsafe or not to get the expected quality… All those risks are too often underestimated and too lately, which finally leads to development delays and uncontrolled budget.

 

Quality by Design is a good development practice (ICH Q8(R2)) that could help you to avoid those adverse effects. Proposed and strongly recommended by international health agencies such as FDA and EMA, QbD is used in all big pharmaceutical industries. Unfortunately, QbD is not “Plug and Play” and requires expertise to be efficiently implemented. To make it accessible to SME and start-ups, CYBERNANO has developed easyQBD : a SaaS platform designed to achieve a triple objective:

  • Facilitate the QbD understanding

  • Speed-up its implementation

  • Estimate risks with more precision

 

All-in-one service, easyQBD allows you to get the best statistical tools with the best experts to the benefit of your product. It allows you to

  • Speed up the development phase by addressing the critical factors of risk as soon as possible

  • Rapidly optimize performances

  • Better control quality and safety during all the life cycle of the product

  • Get development timeline and costs under control

Go further

Use Cases ...

Magnetic NP
nanoXD
K-prosthesis
siRNA LNP
BioProcess
MD Soft
Microfluidics
PhotoTherapy
Our Scientific Expertise

  • EXPERT, developing an effective off-the-shelf platform-based nanosized delivery system for mRNA and to execute the first-in-man clinical study with this formulation, H2020 SC1-BHC, 2019-2024

  • TBMED, An Open Innovation test bed for the development of high-risk medical devices, H2020 NMBP, 2018-2022

  • M3ODALIty, Modular, Multivalent and Multiplexed tOols for DuAl moLecular Imaging, ANR, 2017-2020

  • NanoBiT, Nanoscintillator‐Porphyrin Complexes for Bimodal RadioPhotoDynamic Therapy, EuroNanoMed II, 2016-2018

  • PhotoBrain, AGuIX theranostic nanoparticles for vascular-targeted interstitial photodynamic therapy of brain tumors, projet, EuroNanoMed II, 2015-2017.

  • Nano-Xrays, Nanoparticles-based X ray-induced photodynamic therapy in glioblastoma multiforme, INCA, 2012-2015

  • PDTX, Active Nanoplatforms for Photodynamic Therapy, ANR-P2N, 2011-2014

  • Target-PDT, Photodynamic Therapy using photosensitizer-doped targeted organic nanoparticles, EuroNanoMed I, 2009-2013

See more

  • ACCESS, Advanced Cell Control by Spectroscopic Sensors, BPIfrance - Grand Défi Bio- production, Biomédicament : améliorer les rendements et maîtriser les coûts de production, 2021-2024 

  • EXPERT, developing an effective off-the-shelf platform-based nanosized delivery system for mRNA and to execute the first-in-man clinical study with this formulation, H2020 SC1-BHC, 2019-2024

  • TBMED, An Open Innovation test bed for the development of high-risk medical devices, H2020 NMBP, 2018-2022

  • M3ODALIty, Modular, Multivalent and Multiplexed tOols for DuAl moLecular Imaging, ANR, 2017-2020

  • NanoBiT, Nanoscintillator‐Porphyrin Complexes for Bimodal RadioPhotoDynamic Therapy, EuroNanoMed II, 2016-2018

  • PhotoBrain, AGuIX theranostic nanoparticles for vascular-targeted interstitial photodynamic therapy of brain tumors, projet, EuroNanoMed II, 2015-2017.

  • Nano-Xrays, Nanoparticles-based X ray-induced photodynamic therapy in glioblastoma multiforme, INCA, 2012-2015

  • PDTX, Active Nanoplatforms for Photodynamic Therapy, ANR-P2N, 2011-2014

  • Target-PDT, Photodynamic Therapy using photosensitizer-doped targeted organic nanoparticles, EuroNanoMed I, 2009-2013

Our References

  • Regulatory Toxicology and Pharmacology, 2019.

  • Nanotechnology, Biology, and Medicine, June 2017.

  • Int J Nanomed, 2016.

  • IEEE Transactions on NanoBioscience, 2016.

  • Theranostics, 5(9) : 1030–1044, 2015.

  • IEEE Transactions on NanoBioscience, pages Volume:PP , Issue: 99, Apr. 2015.

  • Inorganica Chimica Acta, 414:134–140, Apr. 2014.

  • Journal of Photochemistry and Photobiology B: Biology, 117:80–89, Dec. 2012.

  • PLoS ONE, 7(11):e48617, Nov. 2012.

  • Theranostics, 2(9):889–904, Sept. 2012.

  • Photochemical and Photobiological Sciences, 10(5):842–851, May 2011.

  • Pharmaceutical Research / Pharmaceutical Research (Dordrecht), 27(3):468–479, 2010.

  • International Journal of Radiation Oncology, Biology, Physics, 75(1):244–252, 2009.

  • Journal of Medicinal Chemistry, 51(13):3867–3877, June 2008.

See more

  • ASME Journal of Medical Devices, 2022.

  • PLOS One, 2020.

  • Regulatory Toxicology and Pharmacology, 2019.

  • Nanotechnology, Biology, and Medicine, June 2017.

  • Int J Nanomed, 2016.

  • IEEE Transactions on NanoBioscience, 2016.

  • Theranostics, 5(9):1030–1044, 2015.

  • IEEE Transactions on NanoBioscience, pages Volume:PP , Issue: 99, Apr. 2015.

  • Inorganica Chimica Acta, 414:134–140, Apr. 2014.

  • Journal of Photochemistry and Photobiology B: Biology, 117:80–89, Dec. 2012.

  • PLoS ONE, 7(11):e48617, Nov. 2012.

  • Theranostics, 2(9):889–904, Sept. 2012.

  • Photochemical and Photobiological Sciences, 10(5):842–851, May 2011.

  • Pharmaceutical Research / Pharmaceutical Research (Dordrecht), 27(3):468–479, 2010.

  • International Journal of Radiation Oncology, Biology, Physics, 75(1):244–252, 2009.

  • Journal of Medicinal Chemistry, 51(13):3867–3877, June 2008.

Few docs on QbD

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