SCIENTIFIC PROOF.

PRODUCT SAFETY

DO YOU WANT scientific proof that your products can be applied safely? WE PERFORM the controls by means of our certified biological test systems. Some of these verifications are obligatory for approval for investigational use of test products in clinical trials.

 

SAFETY ASSESSMENTS.

2D AND 3D CELL CULTURE MODELS

Plant screening is essential for the safety of plant derived cosmetics and pharmaceuticals. Profound characterization of their composition and proof of reproducibility of the specified formulation is a precondition for admission of plant-based pharmaceuticals for investigational application in clinical trials. The so-called lead substances, in particular, must be well characterized in order to assure consistent quality of medicinal products. For the certification of plant cosmetics, it is mandatory to prove that the final products are free of contaminants and don’t cause any damage or irritation. The extent of the requirements, though, varies between different quality labels.

2D and 3D CELL CULTURES IN PHYTOCOSMETICS

In our labs we have established test systems based on 2- and 3-dimensional cell cultures. They reflect the features of tissues and organs (e.g. skin, lungs, intestines, liver, tumor tissue) in the context of the human body, with 3d cell cultures resembling natural conditions most closely. Analysis and interpretation of results are carried out in fully automated cell culture systems. This helps saving time and money when assessing an enormous amount of samples.

Our test systems for the exclusion of harmful effects:

  • Skin corrosion and irritation OECD TG 439 and OECD TG 431
  • Proof of skin sensitizers (IL-18 release)
  • Integrity of the epidermal barrier function

Those analysis can be performed on the final product, namely the final formulation. They are a highly valuable substitute for testing on animals or humans.

SAFE EXPLOITATION OF HIGH POTENTIAL

The Mexican sunflower (tithonia diversifolia), originating from Central and South America, is a vivid example for the dualistic nature of many plants. This plant is high in proteins and other nutrients and produces a considerable amount of biomass. Therefore, in South America efforts for the use of this plant as forage crop are on the way. In traditional medicine, the Mexican sunflower was successfully applied in fighting gastro-intestinal parasites. A hinderance for its wide usage is the high concentration of sesquiterpene lactones, above all tagitinine C, which are dangerous liver toxins. On the other hand, it is just because of these very compounds that the plant is subject to medical research for various application. This illustrates nicely the importance of good characterization of all active compounds for a safe application of plant products and of precise dose adjustment.

INTERNATIONAL SAFETY EXPERTISE.

PYRROLIZIDIN ALKALOIDS

Based on his special expertise in this field, Prof. Bonn was invited by the Ministry of Health to join the working party for pyrrolizidin alkaloids (PA) of the European Pharmacopoeia Commission under the European Directorate for the Quality of Medicines & HealthCare, Council of Europe.

Pyrrolizidin alkaloids (PA) are secondary plant components. Most of them represent a health risk for humans and animals, but they protect the plants from herbivores and insects. Because of their protective effects, they are widespread among plant species, and are also present in many food crops and healing plants. For producers of plant products, consequently, it is of high importance to ensure through appropriate measures, that the final products do not contain any PAs.

  • Presumably 3% of all flowering plant species worldwide contain toxic PAs.
  • More than 660 PAs und PA nitrous oxides (PANO) have been found in 6.000 plant species, so far. Roughly 50% of them are toxic to the liver.
  • PAs can trigger coronary heart disease and induce mutations which may cause cancer.

We possess the skills and the machinery to provide state-of-the-art support for the development and production of safe products of consistent high quality.

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