Cybernano

easyQBD

A Quality by Design Platform to boost the development of

your innovative Pharmaceuticals and Medical Devices

Quality by Design in 3 minutes

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

CYBERnano brings its expertise and platform

easyQBD

to facilitate the implementation of Quality by Design

in this project.

Why easyQBD ?

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

I need information

Use Cases ...

Image de Reproductive Health Supplies Co

GlycoBone

QbD for the development of an injectable hydrogel tailored for oral bone defect reconstruction

Maghemite_silica_nanoparticle_cluster.jp

Magnetic NP

Quality-by-Design applied to the development of Magnetic Nanoparticles for Hyperthermia

nano-XD

Design of Simulated Experiments for the optimization of nanoparticles activated by X-ray in radiotherapy.

K-prosthesis

Quality-by-Design for a safe development of a biocompatible and flexible synthetic cornea

siRNA LNP

Quality-by-Design for the safe development of lipid nanoparticles devoted to siRNA delivery

BioProcess

Quality-by-Design for the production optimization of bioprocesses

MD Soft

Quality-by-Design for the risk and robustness analysis of software devoted to medical applications

Microfluidics

Quality-by-Design for the safe development of nanocarriers produced by Microfluidics

PhotoTherapy

Quality-by-Design for the risk analysis of a medical device prototype in photodynamic therapy

A few docs on QbD ?

You will find below a set of relevant documents to know more about QbD.

Our Quality-by-Design cycle:

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

Our References :

Blanka Halamoda-Kenzaoui, Simon Baconnier, Thierry Bastogne, Didier Bazile, Patrick Boisseau, Gerrit Borchard, Sven Even Borgos, Luigi Calzolai, Karin Cederbrant, Gabriella di Felice, Tiziana Di Francesco, Marina Dobrovolskaia, Rogério Gaspar, Belén Gracia, Vincent A. Hack- ley, Lada Leyens, Neill Liptrott, Margriet Park, Anil Patri, Gert Roebben, Matthias Roesslein, René Thurmer, Patricia Urban Lopez, Valérie Zuang, and Susanne Bremer-Hoffmann. Bridging communities in the field of nanomedicine. Regulatory Toxicology and Pharmacology, 2019.
T. Bastogne, Quality-by-design of nano-pharmaceuticals - A state of the art, Nanomedicine: Nanotechnology, Biology, and Medicine, June 2017.
P. Retif, A. Reinhard, H. Paquot, V. Jouan-Hureaux, S. Pinel, and T. Bastogne. Monte carlo simulations to predict the in vitro ranking of radiosensitizing nanoparticles. Int J Nanomed, 2016.
P. Retif, T. Bastogne, and M. Barberi-Heyob. Robustness analysis of a geant4-gate simulator for nano- radiosensitizers characterization. IEEE Transactions on NanoBioscience, 2016.
P. Retif, S. Pinel, M. Toussaint, C. Frochot, R. Chouikrat, T. Bastogne, and M. Barberi-Heyob. Nanoparticles for radiation therapy enhancement: the key parameters. Theranostics, 5(9):1030–1044, 2015.
J.-B. Tylcz, T. Bastogne, H. Benachour, D. Bechet, E. Bullinger, H. Garnier, and M. Barberi-Heyob. A Model-based Pharmacokinetics Characterization Method of Engineered Nanoparticles for Pilot Studies. IEEE Transactions on NanoBioscience, pages Volume:PP , Issue: 99, Apr. 2015.
M. Pernot, N. P. E. Barry, T. Bastogne, C. Frochot, M. Barberi-Heyob, and B. Therrien. Rational design of an arene ruthenium chlorin conjugate for in vivo anticancer activity. Inorganica Chimica Acta, 414:134–140, Apr. 2014.
M. Pernot, T. Bastogne, N. P. E. Barry, B. Therrien, G. Koellensperger, S. Hann, V. Reshetov, and M. Barberi-Heyob. System biology approach for in vivo photodynamic therapy optimization of ruthenium-porphyrin compounds. Journal of Photochemistry and Photobiology B: Biology, 117:80–89, Dec. 2012.
H. Benachour, T. Bastogne, M. Toussaint, Y. Chemli, A. Sève, C. Frochot, F. Lux, O. Tillement, R. Vanderesse, and M. Barberi-Heyob. Real-time monitoring of photocytotoxicity in nanoparticles- based photodynamic therapy: a model-based approach. PLoS ONE, 7(11):e48617, Nov. 2012.
H. Benachour, A. Sève, T. Bastogne, C. Frochot, R. Vanderesse, J. Jasniewski, I. Miladi, C. Billotey, O. Tillement, F. Lux, and M. Barberi-Heyob. Multifunctional peptide-conjugated hybrid silica nanoparticles for photodynamic therapy and MRI. Theranostics, 2(9):889–904, Sept. 2012.
V. Morosini, T. Bastogne, C. Frochot, R. Schneider, A. François, F. Guillemin, and M. Barberi-Heyob. Quantum Dot-folic acid conjugates as potential photosensitizers in photodynamic therapy of cancer. Photochemical and Photobiological Sciences, 10(5):842–851, May 2011.
D. Bechet, L. Tirand, B. Faivre, F. Plénat, C. Bonnet, T. Bastogne, C. Frochot, F. Guillemin, and M. Barberi Heyob. Neuropilin-1 targeting photosensitization-induced early stages of thrombosis via tissue factor release. Pharmaceutical Research / Pharmaceutical Research (Dordrecht), 27(3):468–479, 2010.
L. Tirand, T. Bastogne, D. Bechet, M. Linder, N. Thomas, C. Frochot, F. Guillemin, and M. Barberi-Heyob. Response surface methodology: an extensive potential to optimize photodynamic therapy con- ditions in vivo. International Journal of Radiation Oncology, Biology, Physics, 75(1):244–252, 2009.
J. Gravier, R. Schneider, C. Frochot, T. Bastogne, F. Schmitt, J. Didelon, F. Guillemin, and M. Barberi-Heyob. Improvement of m-THPC-like photosensitizer selectivity with folate-based targeted delivery. Synthesis and in vivo selective delivery study. Journal of Medicinal Chemistry, 51(13):3867–3877, June 2008.