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EUROSTARS - A partner to carry out preclinical in vitro and in vivo testing is sought for the development of liquid formulations for oral drug delivery of biologics

Resumen

Tipo:
Búsqueda de socios
Referencia:
RDES20200714003
Publicado:
18/07/2020
Caducidad:
27/07/2020
Resumen:
A Spanish SME developing its formulation platform for the oral administration of drugs, with special interest for biologic actives, is looking for a partner expert in the preclinical biological testing of oral drug formulations to submit a proposal to the next EUROSTARS call. In this project, the company wants to demonstrate how this system allows the oral administration of drugs that currently need to be administered intravenously, including biologic compounds.

Details

Tittle:
EUROSTARS - A partner to carry out preclinical in vitro and in vivo testing is sought for the development of liquid formulations for oral drug delivery of biologics
Summary:
A Spanish SME developing its formulation platform for the oral administration of drugs, with special interest for biologic actives, is looking for a partner expert in the preclinical biological testing of oral drug formulations to submit a proposal to the next EUROSTARS call. In this project, the company wants to demonstrate how this system allows the oral administration of drugs that currently need to be administered intravenously, including biologic compounds.
Description:
There is a challenge in the oral administration of biologic drugs. Biologics are used to treat a variety of chronic diseases, but they are labile, difficult to formulate, very expensive and usually need to be administered intravenously. Oral delivery has lower costs and higher patient compliance. A Spanish SME has developed a sustainable proprietary nanoformulation platform which improves the quality and performance of pharmaceutical actives.

The proprietary formulation platform developed by the SME delivers next generation nanomedicines and new delivery systems to pharma and biotech companies, with tailored and improved properties in terms of bioavailability, stability, addressability, and multifunctionality, protecting and stabilizing from small molecules to proteins and biomolecules, integrating and stabilizing them on solid particles or nanovesicles.

The company has already developed innovative, stable and robust liquid formulations for topical, subcutaneous and parenteral administration of biologics (growth factors, enzymes) based on novel non liposomal nanovesicles produced using a green (single step, supercritical CO2 based) patent protected manufacturing process.

These novel nanovesicles are multifunctional systems that can integrate both hydrophilic and lipophilic drugs with high payloads. In addition, these colloidal systems are stable for periods as long as several years, their morphology do not change upon rising temperature or dilution, and they show outstanding vesicle to vesicle homogeneity regarding size, lamelarity and membrane supramolecular organization. Besides, they are suitable for sprayable, lyophilisable and gel-like formulations

The SME is currently developing its formulation platform for the oral administration of drugs, with special interest for biologic actives, and is looking for a partner expert in the preclinical biological testing of oral drug formulations. In this project, the company wants to demonstrate how this system allows the oral administration of drugs that currently need to be administered intravenously, including biologic compounds.

To do so, known model drug substances will be conjugated to nanovesicles, physico chemically characterized. A formulation strategy has been defined to preserve the integrity of the nanoconjugate in gastric fluids. The stability of the formulations in simulated gastric and intestinal fluids will be evaluated and the nanoconjugates optimized following a quality by design strategy. A partner is sought to evaluate the in vitro permeability (absorption) in small intestine, ( using 2D or 3D systems such as scaffolds) or in human intestinal mucosa (e.g. Franz Cell or other models), perform in vitro cytotoxicity assays (Caco-2 or other relevant cell cultures) and finally to perform in vivo tests to study the nanovesicles permeability (absorption) in small intestine (e.g. in rats).

The company is preparing a proposal for an Eurostars call. They will be the project leaders. A new full-fledged partner will be included in the consortium in order to carry out with previously described assays. The partner will manage its own budget to accomplish the objectives. The partner must follow Eurostars program selection criteria and be located in the participant countries of the programme.

The deadline for the call is the 3rd September 2020.
The expressing of interest for participation is 27th July 2020.
The project will last between 2 and 3 years

Stage of Development:
Proposal under development
IPR Status:
Patents granted

Partner sought

Partner Sought:
Laboratories/research groups with expertise in preclinical in vitro/in vivo testing of medicines for oral route, to evaluate the efficacy of novel oral formulations of biologics. They should be eligible for EUROSTARS funding. Specifically, the following activities are sought: · In vitro permeability assays absorption in small intestine. (2D or 3D systems -scaffolds) or in human intestinal mucosa · In vitro cytotoxicity assays (Caco-2 or other relevant cells) · In vivo test to study the DELOS nanovesicles permeability (absorption) in small intestine (e.g. in rats) · In vivo preclinical toxicology studies (optional) · Pharmacokinetics and biodistribution of DELOS nanovesicles orally administered (optional) · Models to study sublingual absorption (optional)
Type of Partnership Considered:
RDR

Client

Type and Size of Client:
Industry SME 11-49
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
Spanish

Dissemination

Restrict dissemination to specific countries:
Austria
Belgium
Bulgaria
Canada
Croatia
Cyprus
Czech_Republic
Denmark
Estonia
Finland
Germany
Greece
Hungary
Iceland
Ireland
Israel
Italy
Korea, Republic Of
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Sweden
Switzerland
Turkey
United Kingdom

Programme-call

Framwork Programme:
Eureka
Evaluation Scheme:
Single stage, deadline 3rd September
Coordinator Required:
No
Deadline for Call:
03/09/2020