In vitro analysis

I am Dr. Lars Rüther and I  take care of in vitro analysis here at Dermatest.

In vitro testing allows products to be tested for tolerability and efficacy before or instead of testing on a human subject. Based on many years of experience with this type of analysis and our state-of-the-art laboratory, in vitro analysis at Dermatest has several benefits to offer:

  • using physical, histological and biochemical techniques, specific claims can be made regarding the effects of a product on biological processes in human skin.
  • 3D models of the skin, grown from primary human cells, adequately reflect the natural properties of native human skin including all tyical skin layers as well as expression of characteristic markers.
  • comprehensive quantitative and qualitative assessment of various parameters is available
  • aspects which cannot be tested on human subjects, such as irritation tests, wound healing studiesinflammation or penetration/permeation can still be investigated
  • techniques can be adapted to the individual product and matter at hand, so that almost every aspect of tolerability and safety can be addressed
  • testing can often be done rapidly, as no human subjects are involved in the study

In vitro analysis

Tests on human subjects are unsuitable or even unable to address many issues or questions. Such testing is often associated with health or safety risks for the test subjects, hence, it is banned on ethical grounds or impossible in practice. This is why here at Dermatest we also use primary skin cells and 3D models of the skin when looking at complex issues. We can offer the following tests which meet validated OECD and DIN EN ISO (for medical devices) protocols:

Medical products

For medical products (MP) with contact to human skin, assessment of Cytotoxicity, Irritation and Sensitization is recommended according to DIN EN ISO 10993:2006 depending on classification of MP tested.

Difference between DIN EN ISO 10993-10:2013 and DIN EN ISO 10993-23:2021

DIN EN ISO 10993-10:2013 DIN EN ISO 10993-23:2021
neat medical products extracts (polar and non-polar vehicle)
15 min exposure + 42 hours post-incubation 18 ± 2 hours incubation
25 µl / 25 mg product used 100 µl product extract used
skin and other models (e.g. vaginal) are possible only skin models

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Measurement techniques

In vitro analysis is of great importance in the field of product testing, as certain tests cannot be carried out on human subjects. Depending on the particular study design, in vitro analysis can also precede an application test. Here at Dermatest, we offer a wide range of testing options, allowing you to focus on the potential of your product and showcase its properties. We would be delighted to prepare an individual, tailored quote for you.

3D model of the skin

In order to provide you with the best possible testing methods for your product, our in vitro work is done using Phenion® skin models from Henkel® as well as EpiDermTM models from MatTek. The models are composed entirely of human skin cells (keratinocytes and fibroblasts). The design is modelled on human skin which it resembles in both anatomical and physiological properties. It consists of a fully differentiated epidermis and underlying dermis, containing connective tissue made from natural collagen synthesized by human fibroblasts. These highly specific human skin tissue models can be used to broaden our basic cosmetic research and assess the safety of raw materials and products. The investigations and tests which we perform on these models are as close as possible to native human skin and you get meaningful, marketable results.

FAQ

The start and duration of an application test is strongly dependent on the study design and availability of appropriate skin models. Usually it takes 3-4 weeks after product arrival to conduct the study and finalize the expert opinion.

Unlike in vivo studies in vitro only needs a very small amount of a product (5 ml or 5 g) or substance. The amount of product for application ranges between 1- 100 µl or 1 – 50 mg  depending on the study design. Frequency of use should be taken into account. We do not need a retention samples or spare samples.

Besides the product samples, the qualitative INCI names or composition of the test product is needed for all testing. As an order confirmation, we need the study protocol to be returned to us, signed (digital format is sufficient).

We offer various tests design which can always be adapted by the customer to suit the preferred test design or needs.

No. In addition to cosmetic products, we also test consumer goods, medical devices and biocides for skin tolerability according to currently valid OECD testing guidelines or DIN EN ISO protocols.

Test methods

Vitality, cell renewal and anti-aging effects

Integrity of the skin barrier/regeneration and protection from damage

Antioxidant potential

Wound healing & inflammation

Penetration/permeations testing

TEER

transepithelial electrical resistance

ELISA

Enzyme-linked Immunoabsorbent Assay

Phototoxicity testing

OECD TG 498

Skin corrosion testing

OECD TG 431

Skin irritation testing

OECD TG 439

Eye irritation testing

OECD TG 492

Cytotoxicity testing

DIN EN ISO 10993-5:2009

Irritation testing

DIN EN ISO 10993-10:2013

Irritation testing

DIN EN ISO 10993-23:2021

Our team is at your disposal

Dr. Lars Rüther

Dr. Lars Rüther

Head of In Vitro Analyses and Research projects

Schnellkontakt

Rufen Sie uns unter 0251 481637-0 an oder senden Sie eine Nachricht. Wir melden uns umgehend bei Ihnen.
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