Support services platform for "Quality by design" process in the frame of nano-drugs development
A French Start-up, with expertise in Nano-drugs development, has developed a secured web-based platform that automatically guides non-experts through the "Quality by Design" workflow, also assisted by a biostatistician for the risk analysis, design of experiments and process controls. Service agreement or technical cooperation agreement is sought with developers of Nano-drugs who could use the platform for their own projects, where the company could enhance the solution.
A nano-drug consists of two things: an active principle (molecule that will cure the diseased area) and a vehicle (scientific term: vector) of nanometric size. The vehicle of the nano-drug is able to transport the molecule to the infected zone - a gene, a protein, a cell, an organ - and to treat directly the infected cells without damaging the healthy cells around. Nano-drugs are promising prospects for treating severe diseases such as cancer, diabetes, Alzheimer's, multiple sclerosis. But development of nano-drugs generally requests a large number of experimentations to find the good molecule configuration and good process parameters, ensuring safety for the patient.
A French Start-up has developed the first collaborative platform designed to broaden the use of Quality-by-Design for Nano-drugs development. Pharmaceutical Quality-by-Design is a risk-based approach of drug development based on the understanding of both the product and the process. Its main objective is to identify, analyze and control all causes of variations that could finally alter quality and safety of the drug. To that aim, this approach employs several statistical methods and tools such as prior risk analysis, design of experiments, multivariate analysis and statistical process control. Quality by Design is now strongly recommended by U.S. Food and Drug Administration and European Medicines Agency in all drug development projects.
Innovating for over 10 years in the development of rational methods of design and production of new molecules, the company has developed strong expertise in statistical design of experiences. The Quality by Design platform is a collaborative service for physicists, biologists and chemists who wish to be assisted in the development of their molecules and nanoparticles in compliance with the Food and Drug Administration and European Medicines Agency guidelines related to Quality-by-Design.
The interactive internet platform guides them in each stage of their preclinical developments through an ergonomic and easy to use interface.
During the development phases, the client is assisted by a biostatistician for the risk analysis, design of experiments and process controls, who is involved in every step of Quality by Design process. Thanks to the service, from several millions of possible formulations, the user will identify less than 100 prototypes, drastically reducing the number of experiments needed. Service agreement or technical cooperation agreement is sought with developers of Nano-drugs developers.
Advantages:
Thanks to the platform and support services, Nano-drugs developers will be able to:
- demonstrate to the FDA & EMA both the product's knowledge and its process of manufacturing.
- improve the quality and control safety by risks analysis of their product,
- significantly reduce the risks of non-compliance
- drastically reduce the number of necessary experimentations
- saving time and money in preclinical development
- with the collaborative platform, users spread over several European countries can work remotely
Type and Role of Partner Sought:
Services agreement is sought with developers of nano-drugs who would be interested in using the platform and services in the frame of their own drugs development. Technical cooperation agreement is also sought in the frame of collaborative projects where the company could enhance the platform and services features and performance.
