2D AND 3D CELL CULTURES
During the manufacturing process, the monitoring includes a series of tests, in order to ensure product efficacy and safety. These comprise testing of raw materials as well as monitoring the intermediates and the final formulations. Many of those quality control tests are mandatory for application to clinical trials and for product certification. The requirements for the filing data also include stability data documenting the products’ shelf life.
For herbal raw materials and final products high purity standards apply because of their special nature as natural substances. Precise documentation of the concentration of the specific lead substances is obligatory. Furthermore, it must be proven, that pollutants such as aflatoxins, heavy metals, pesticides and microbial parameters do not exceed the respective maximum levels.
Controls for Raw Material
The fact, that the concentration of individual compounds, and their composition in plant extracts, may considerably vary between different batches of raw materials, is a challenge in the manufacturing of natural products. Customized quality control tests enable manufacturers to check whether the purchased material is of appropriate quality.
B2B: Controls of Distributors
Many manufacturers of branded products cooperate with distributors to market their goods. Appropriate quality control tests allow you to make sure that materials bottled by packaging service providers or marketed by contractors, maybe via vending machines, are the original ones of the respective label (and not just similar products of lower quality).
2D and 3D Cell Culture Systems,
e.g. for the exclusion of harmful properties
In our laboratories we have established test systems based on 2D and 3D 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 save time and money when assessing enormous numbers of samples.
Examples for the exclusion of harmful properties:
- Safety assessments (skin corrosion, irritation OECD TG 439, OECD TG 431)
- Identification of skin sensitizers (IL-18 release)