Glass as a Critical Player in the Pharmaceutical Industry
For over 40 years, EAG has been involved in the entire glass value chain, from raw starting materials to final products.
Principles and Strengths of In Vitro Testing
Principles of In Vitro Testing
In vitro is the Latin term for “in glass,” meaning that the testing is performed in a container that is outside of a living organism. This testing uses cell-based biological models instead of animals or humans. In vitro efforts help fulfil the FDA’s “3Rs approach” to replace, reduce, and/or refine animal testing.
Replace
- Develop and explore tests that replace the need for animal models.
Reduce
- Minimize the number of animal models in experimentation.
Refine
- Reduce the suffering and stress of laboratory animals and improve their wellbeing.
In Vitro model systems can be specified to the test sample’s intended use. 2D cell cultures are grown rapidly for high-throughput or multi-sample analysis with minimized variation between treatments. Cell cultures can also be made into 3D tissue models. These models contain differentiated cell layers to physiologically represent complex tissues and evaluate specific endpoints. Using specific geometries, in vitro cell culture models can be used to evaluate simple and complex biological responses.
To assess different biological endpoints, various forms of analytical methods may be implemented. Measurable responses of the in vitro models include cell death, growth inhibition, genetic alterations, changes in surface marker expression and altered metabolism.
Technical Specifications
- Cytotoxicity
- Qualitative evaluation of cell cultures under a microscope
- Quantification of cell morphology and growth via automated cytotoxicity scoring
- Quantification using a cell viability reagent, measured by a spectrophotometer
- Irritation
- Quantification using a cell viability reagent, measured by a spectrophotometer
Strengths of In Vitro Testing
- Rapid results
- Suitable for high throughput testing
- Economically and ethically favorable compared to animal testing
- Minimized presence of biological variables
- 3D tissues results include the effects of cell-cell interaction
- Several endpoints can be measured
- Customization of study details during early-stage sample development
Limitations of In Vitro Testing
- Not all models account for the impact of complex physiological systems such as hormones and immunity
- Some in vitro models for biological endpoint assessment may not be accepted by all regulatory bodies
- Cannot identify mechanisms that lead to adverse biological results without further testing or chemical characterization
Related Resources
- Brochure: In Vitro Biocompatibility Testing
- Service: In Vitro Biocompatibility
- Service: In Vitro Skin Irritation Testing
- Service: In Vitro Cytotoxicity Testing
- Industry: Medical Devices
- Blog: Frequently Asked Questions About In Vitro Irritation and Cytotoxicity Testing
- Blog: The Conspicuous Case of the Missing T0 in ISO 10993-5 Cytotoxicity Testing
- Application Note: Next Steps After Receiving a Cytotoxic Result
More content you might like...
The Power of SEM-EDS in Imaging and Elemental Analysis
SEM equipped with EDS can capture detailed images and identify elements simultaneously on the surface of samples.
Characterization of Crystalline structures – SEM-EBSD vs TEM-PED
Besides images provided by SEM and TEM, different attachments can be added to reveal crystalline information, including (SEM-EBSD) and TEM (TEM-PED).
Essentials of Particulate Testing: USP <788> and AAMI TIR42
Essentials of Particulate Testing: USP <788> and AAMI TIR42 While there are many standards available for particulate testing, USP <788> and AAMI TIR42 are the most important. This is especially