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Análisis de los posibles efectos tóxicos de productos industriales en la salud humana y animal antes de su comercialización

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOIT20161024010
Publicado:
23/12/2016
Caducidad:
22/12/2017
Resumen:
Un laboratorio italiano que sigue los principios de BPL (Buenas Prácticas de Laboratorio) está especializado en evaluar los posibles efectos tóxicos para la salud de un producto antes de su comercialización. Para ello realiza ensayos de toxicidad no clínicos in vivo de productos innovadores. Los productos analizados incluyen medicamentos, productos farmacéuticos y veterinarios, pesticidas, cosméticos, alimentos, aditivos alimenticios y productos químicos industriales. El laboratorio busca socios en los sectores de farmacia, medicina, alimentación y piensos con el fin de establecer acuerdos de servicio o cooperación técnica.

Details

Tittle:
Non-toxic effect analysis for human and animal health on industrial products before marketing
Summary:
An Italian laboratory certified for Good Laboratory Practices (GLP), assess possible toxic effects on health before products are marketed via in-vivo non-clinical toxicity trials on innovative products. Products tested include: drugs, pharmaceutical and veterinary products, pesticides, cosmetics, food and feed additives and industrial chemicals. The lab seeks industrial partners in pharma, medical, feed and food sector, under services agreement or technical cooperation agreement.
Description:
An important Italian laboratory in the Emilia-Romagna region is certified for Good Laboratory Practices (GLP) by the Italian Health Ministry. The lab helps companies in the pre-market phase, by performing toxicity trials on new products and assessing effects on human and animal health before products are marketed. The laboratory supports the manufacturing sector on properly classify, assess, register and distribute innovative products according to EU directives and avoiding wrong investments. The team gathers scientists in biology, biotechnology, veterinary medicine, medicine and surgery, laboratory technicians.

*Problem:
Chemicals control legislation in advanced countries is nowadays based on the prevention approach: preventing risks by assessing potential hazardous characteristics in chemicals contained in products, before they enter the market. An extended application of the precautionary principle beyond the environment currently includes protection of consumers and human, animal and vegetable health: there has to be an hazard control strategy whenever scientific information available is insufficient to ensure absence of risk.
Enterprises have to demonstrate there are not health hazardous elements in their new products before these are sold on the market.

*Solution
Good Laboratory Practices (GLP) were developed -and internationally agreed upon- to promote data quality and validation from experimental tests, useful in determining safety from chemicals. The OECD (Organization for Economic Cooperation and Development) defines GLP as a shared quality system, concerning the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

The Italian laboratory has been performing in-vivo non-clinical toxicity studies since 1969 to define effects of various agents and products on health. Tests are based on methodologies common to all OECD States. The laboratory evaluates the effects of chemicals in:
- drugs
- pharmaceutical products
- pesticides
- veterinary products
- food additives
- feed additives
- industrial chemicals
- detergents
- cosmetics
and similar having chemical, biological and/or natural origin.

*Tests and pre-market phase:
As many human exposure scenarios as possible are reproduced during these laboratory tests. The priority is to avoid human and economic costs of an incomplete product planning, knowing how difficult is to manage a crisis related to products, if already on the market. The laboratory covers several related fields for companies in the pre-marketing process, trying to avoid crisis by a proper preliminary planning.
The laboratory, in fact:
- supports industry in understanding REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classification, Labeling and Packaging) regulations
- helps companies implementing industrial strategies by offering technical and scientific know-how at every stage of the production cycle
- cooperates with clients on research and development
- prepares scientific and registration dossiers with the company to declare product safety
- helps in maintaining productivity and competitiveness while observing EU legislation
- performs toxicity trials on new products before they are sold.

The laboratory studied 210 agents and conducted a great number of studies. There is no other single laboratory in the world having performed such a high number of studies in the very same structure (no outsourcing, no process fragmentation). This allows the laboratory to define the project evaluating any detail and acquiring all the information required by the authorities just by single trial, without the need to repeat it or to deepen it.

The laboratory now seeks industry partners in pharma, medical, feed and food sector under services agreement or technical cooperation agreement.
Advantages and Innovations:
- high technological expertise, also proved by GLP institutional certification
- Good Laboratory Practices are accepted by all regulatory authorities in the European Union, including the European Medicines Agency (EMA) for approval of new drugs and the European Food Safety Authority (EFSA)
- The partnership with the certified laboratory ensures that innovative products launched on the market are increasingly risk-free
- These trials avoid wrong economic investments by companies
- Trials prevent crisis management scenarios if toxicity is assessed in a negative way after the market penetration of a product
- Trials prevent risks on animal, human and environmental health
- No other single laboratory in the world have performed such a high number of studies in just one single structure and with a small team, if compared with other big international similar laboratories
- This way, there is no outsourcing or process fragmentation
- This allows the Italian laboratory to perform each project evaluating any detail and acquiring all the information required by the authorities just by single trial, without the need to repeat it or to deepen it.
- Faster responses
- Personalized assessments are made to find the best analysis process to comply to specific requirements.


Stage of Development:
Already on the market
IPs:
Other

Partner sought

Type and Role of Partner Sought:
- Type of partner sought: industry

- Specific area of activity of the partner: pharmaceuticals, medical devices production, cosmetics and detergents production, feed and food industries

- Task to be performed by the partner: cooperate in defining the strategy, commission tests to the laboratory giving samples of products, be interested in assessing absence of risk for innovative products.

Client

Type and Size of Client:
R&D Institution
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
Italian

Keywords

Technology Keywords:
06001002 Investigaciones clínicas, ensayos
06001012 Investigaciones médicas
09006001 Normas de calidad
09006002 Normas técnicas
06001015 Productos farmacéuticos / medicamentos