nanobiose immunotoxicity of nanoparticles

Immunological Safety
Evaluation

Solutions to assess the impact of
innovative healthcare products

nanobiose-preclinical-services

Preclinical Services

Immunological safety flexible services
from in vitro assay to regulatory support

nanobiose reliable and more predictive evaluation

Reliable and more
predictive evaluation

Lab on a chip based
immunological assays

What We Offer

Nanobiose offers the unique expertise of its seasoned team of experts in immunotoxicology and immunological assessment to propose a comprehensive support to:

  • Increase your confidence in your products
  • Take the most appropriate strategic decisions
  • Mitigate risks and reduce costs
  • Develop your products in accordance with guidelines and regulatory authorities expectations

Why Nanobiose

Because innovative healthcare products are developing fast to cover unmet needs.

As a consequence, there is an increasing need for a better characterization of their impact on human health, in particular their immunological safety.

In this context, Nanobiose founders realised the need to developp more predictive tools for a better in vitro assessment of the immunological safety of such products.

Who We Are

Nanobiose is a specialized company founded in july 2016 in Le Bourget du Lac (France), at the alpine crossroads of Europe. Nanobiose is dedicated to the immunological assessment of innovative products developped in the health sector ranging from:

  • Nanomedicine
  • Nanovectors and Vaccines
  • Biopharmaceuticals
  • Innovative dermocosmetics.
  • Implants

Immunological safety

Immunological safety is a field which is growing along the progresses of innovative healthcare products, whether they are nanodrugs, nanoformulations, constrat agents for imaging, biopharmaceuticals, or dermocosmetics. This is a key component of the general safety profile of such compounds. For example, nanodrugs are subject to the same regulations than classical medecines. Those regulations are described in guidelines edited by the international regulatory authorities like the US Food and Drugs Administration or the European Medicines Agency. In the last years, those agencies regularly increased their requests for experimental assessments concerning the potential side effects of nanodrugs on the immune system, at both the short and the long term.

nanobiose Immunotoxicology
nanobiose nanodrug candidates

Nanomedicine

Extract from the European Technical Plateform for Nanomedicine:

“Nanomedicine is a branch of medicine that applies the knowledge and tools of nanotechnology to the prevention and treatment of disease. Nanomedicine involves the use of nanoscale materials, such as biocompatible nanoparticles and nanorobots, for diagnosis, delivery, sensing or actuation purposes in a living organism. As any medical devices or drugs, nanomedicines are strictly regulated and have to follow thorough characterization, toxicity assessment and multi-stage clinical trials before benefiting patients with their whole potential.

 

The immunological safety of nanoparticles as well as nanomedicines is the focus of several review articles (Dobrovolskaia & McNeil, 2007; Dwivedi et al., 2009; Chang, 2010; Zolnik et al., 2010; Di Gioacchino et al., 2011; Descotes, 2015) as well as books (Dobrovolskaia & McNeil, 2013; Boraschi & Duschl, 2013; Descotes, 2016).

Regulations

Despite the lack of guidelines on the immunotoxicity of nanoparticles or nanomedicines, several guidelines have been published on the immunotoxicity evaluation of various types of chemicals or medicinal products. These guidelines can serve as a relevant basis to propose assays and strategies for the immunotoxicity risk assessment of nanoparticles or nanomedicines.

Major guidelines include:

  • the US FDA/CDRH Immunotoxicity testing guidance on medical devices (1999)
  • the ICH S8 Guideline: immunotoxicity studies for pharmaceuticals (2005)
  • the International Standard ISO 10993-20 on the principles and methods for immunotoxicology testing of medical devices (2006)
  • the US Environmental Protection Agency guideline on the immunotoxicity of pesticides (2007)

 

Major guidelines for biopharmaceutical products include:

  • EMA Guideline on development, production, characterization and specifications for monoclonal antibodies and related products. (2008)
  • EMA Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. (2010)
  • ICH S6(R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals (2011)
  • FDA Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products (2014)
  • EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. (2015)
  • FDA DRAFT GUIDANCE Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (2016)
nanobiose Regulations

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