Veszprém, Hungary: Safety Assessment

Complete your safety studies with fully integrated laboratory support at our Veszprém, Hungary site. Here you'll find more than 100 multispecies rooms, advanced instrumentation, and a skilled team who will conduct your general toxicology, ecotoxicology and specialty studies like DART, inhalation, in vitro and genetic toxicology with maximum efficiency.

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Veszprém, Hungary Safety Assessment site

Safety Assessment Services

With facilities that extend over 12,000 m2 and more than 160 people on staff, our safety assessment facility in Veszprém, Hungary provides a comprehensive range of services for the development of pharmaceuticals, agrochemicals, industrial chemicals, and medical devices, along with extensive experience with novel foods and food additives. The facility operates in compliance with the requirements of GLP and ISO 9001, 14001, and 50001, and is also AAALAC accredited.

As one of the newest facilities in our Safety Assessment family, our site at Veszprém has been integrated into many of the existing global harmonization and unification initiatives to better facilitate a seamless client experience, including:

  • Study plans and report harmonization projects
  • Outline harmonization projects
  • Cross-site audits
  • Communication system integration
  • Provantis 10 and financial system integration (upcoming)

From full programs to stand-alone assessments, our Safety Assessment team at Veszprém performs comprehensive in vivo studies in both small and large animal models, via standard and specialized routes of administration. Our extensive knowledge of global regulatory requirements allows us to design studies to support your worldwide registration of pharmaceuticals, medical devices and animal health products as well as chemicals, agrochemicals, and biocides.

 

Developmental and Reproductive Toxicology (DART)

We offer developmental and reproductive toxicology (DART) program planning and individual study designs to conduct safety assessments for your products according to internationally recognized guidelines, including ICH and OECD. Veszprém has performed over 100 rat and rabbit teratology studies in the last five years.

Available study designs include:

  •     OECD 414 – Prenatal Developmental Toxicity Study
  •     OECD 416 – Two-Generation Reproduction Toxicity
  •     OECD 421 (Screening) or OECD 422 (Combined) - Reproductive Toxicology Study
  •     OECD 443 – Extended One-Generation Reproductive Toxicity Study

 

Inhalation

Inhalation toxicology is performed for pharmaceutical, chemical, and agrochemical clients through repeat-dose studies in both rodents and nonrodents. With 21 rodent exposure systems and six non-rodent exposure systems, the facility has experience in a range of formulations and substances, including liquids, vapors, mineral fibers, dust, powders, and UVBCs. More than 300 inhalation studies have been conducted at the Veszprém site within the past five years.

 

In Vitro Toxicology

The in vitro scientists at Veszprém perform a range of studies, including cytotoxicity, skin irritation and corrosion (OECD 439 & 431), and eye irritation using both ICET and EpiOcular™ models.

 

Genetic Toxicology

A full range of genetic toxicology studies are conducted at Veszprém, including:

  •     Ames test
  •     In vitro mammalian chromosome aberration test
  •     In vitro mammalian cell gene mutation test
  •     In vitro mammalian cell micronucleus test
  •     In vivo rodent micronucleus assay
  •     Mouse lymphoma assay

Terrestrial ecotoxicology studies, including avian and nontarget arthropod, are performed by experienced scientists at Veszprém. The study portfolio includes:

  •     Bobwhite and Japanese quail: acute, dietary, and reproductive toxicology
  •     Bumblebee and honeybee studies: acute oral and contact toxicity
  •     Soil mite studies
  •     Collembola: inhibition of reproduction
  •     Non-target arthropods: laboratory and extended laboratory toxicity studies
  •     Plant toxicity studies (germination and growth)
  •     Nitrogen and carbon transformation
  •     Aged-residue studies

Physicochemistry

Most physicochemical endpoints required under REACH guidelines can be conducted, according to OECD guidelines and in compliance with GLP. The scientists at Veszprém utilize OECD, EU, UN, OPPTS, and CIPAC testing methods to conduct a comprehensive portfolio of analytical and physiochemical studies as well as long-term and accelerated stability testing.

Physicochemical endpoints available include:

  •     Flammability
  •     Flash point
  •     Self-heating temperature
  •     Auto ignition
  •     Solubility
  •     Adsorption coefficient
  •     Pow
  •     Mp/bp
  •     Viscosity
  •     Density
  •     Surface tension
  •     Persistent foaming
  •     Water content

 

Analytical Chemistry

  •     Formulation and dietary analysis
  •     Confirmation of atmosphere concentration in inhalation studies
  •     Dose confirmation in ecotoxicology and genetic toxicology
  •     Method development and validation (> 30 new methods/year)
  •     Active ingredient measurement

 

Anatomic and Clinical Pathology

A comprehensive range of specialty, pathology-based services are available at the site, including:

  •     Necropsy
  •     Histology
  •     Histopathology
  •     Peer review
  •     Hematology
  •     Biochemistry
  •     Urinalysis
  •     Immunohistochemistry

Biocompatibility

Veszprém designs and conducts studies in compliance with ISO 10993 guidelines and has extensive experience with various medical devices such as hydrogels, devices, and patches. The team conducts more than 200 in vitro and 100 in vivo studies per year.

Other study types available include:

  •     Pyrogenicity
  •     Acute systemic toxicity
  •     Hemolysis and hemocompatibility
  •     Intracutaneous reactivity
  •     Muscle or subcutaneous implantation
  •     Subacute/subchronic/chronic toxicity