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Organización de investigación por contrato con certificación de Buenas Prácticas de Laboratorio (BPL) ofrece servicios de descubrimiento y desarrollo preclínico de fármacos

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TODE20161215001
Publicado:
16/01/2017
Caducidad:
16/01/2018
Resumen:
Una empresa alemana con certificación de Buenas Prácticas de Laboratorio (BPL) está especializada en descubrimiento y desarrollo de fármacos para la industria y organismos de investigación en todas las fases preclínicas. La empresa ofrece una amplia variedad de herramientas in vitro de absorción, distribución, metabolismo y excreción (ADME) y herramientas de detección in vivo de alto valor predictivo y cumplimiento normativo. También ofrece servicios bioanalíticos para estudios (pre-) clínicos, sistemas de prueba únicos para necesidades específicas y servicios de investigación en el campo de biomarcadores. La empresa busca socios con el fin de establecer acuerdos de servicio y cooperación en materia de investigación.

Details

Tittle:
GLP (good laboratory practice) certified contract research organization providing pre-clinical drug discovery and development services
Summary:
A specialized GLP certified German company supports drug discovery and development of industry and research organizations in all preclinical stages by offering a wide range of in vitro absorption, distribution, metabolism and excretion (ADME) and in vivo screening tools of high predictive value and regulatory compliance. Bioanalytical services (GLP and Non-GLP) are provided for (pre)-clinical studies.

The company is looking for service agreements and research cooperation agreements.
Description:
The German company provides not only standardized assays including selected ones under GLP, but also customized R-Y-D solutions, which are tailor-made to the individual requirements of the clients or partners. The portfolio covers the complete drug discovery and development testing programme in vitro, in vivo, ex vivo and bioanalysis. In addition to standard set-ups, the company offers a panel of unique test systems addressing specific needs as well as research services on biomarkers.

The broad portfolio includes:

in vitro ADME:
- physico-chemical parameters (solubility, lipophilicity)
- stability
- membrane permeability and transport (Pgp, Caco2, PAMPA,
BBB)
- protein binding (PPB, SPB, Kd)
- drug interaction
- metabolism (CYP inhibition, CYP induction, CYP phenotyping)
- clearance

in vivo pharmacokinetics
- exploratory PK studies (dried blood spot PK, cassette dosing,
identification of major metabolites)
- full PK studies (dose proportionality, organ distribution and
excretion, mass balance, metabolism, first pass effect, PK/PD)
GCLP, GLP and non-GLP bioanalysis
- preclinical and clinical samples (plasma, tissue, urine, faeces
levels, metabolite identification and characterization,
identification of major metabolites, biomarker quantification)
- GLP method development and validation
- fit-for-purpose method development and validation
- GLP bioanalysis for multi-site toxicology studies and clinical
trials

In vitro toxicology
- cytotoxicity
- mechanistic toxicity
- hepatotoxicity
- immunotoxicity
- genotoxicity
- reactive metabolite screening
- predictive toxicology
- 2D cell culture and 3D organoid cultures

in vitro and in vivo pharmacology
- steroid endocrinology (aromatase, 5-alpha-reductase,
CYP17, LHRH, CYP11B1 and CYP11B2)
- diabetes and obesity
- liver fibrosis
- histamine release

The company is looking for service agreements and research cooperation agreements with industrial and academic customers from the pharmaceutical sector.
Advantages and Innovations:
The company offers services for a broad range of applications not widely available and performed individually. The stages cover compound discovery and lead optimization until late preclinical work and, in the case of bioanalytics, up to clinical studies in human.

The highly interactive project design and management assure that customers are provided with information that truly support their decision making process. The company´s major differentiators are accessibility, individualism, timing, cost efficiency, assurance for confidentiality of IP, and a solid regulatory authority track record. Projects are always assigned with the highest level of expertise.
The team consisting of analytical chemists, biologists, veterinarians and pharmacologists has a strong background in the development, validation and performance of in vivo tests for the assessment of pharmacokinetics and pharmacodynamics in small animals as well as in various in vitro methods for the evaluation of potency and safety of potential new drugs.
Stage of Development:
Already on the market
IPs:
Other

Partner sought

Type and Role of Partner Sought:
Services agreement: The company is looking for business partners in the pharmaceutical, phytopharmaceutical, cosmetics and animal health industries.
It is also offering its services to academic or other non-profit organisations of the same sector.

Research cooperation agreement: Furthermore, the company is an experienced and competent partner in European research projects and very interested in participating in Horizon 2020 and other research projects.

Client

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

Keywords

Technology Keywords:
06002007 Ensayos in vitro, experimentos
06001002 Investigaciones clínicas, ensayos
06001015 Productos farmacéuticos / medicamentos