Two Key Guidelines for the Assessment of Skin Irritation: OECD TG 404 and ISO 10993-23:2021In the biocompatibility assessment of c...
Comprehensive Biosafety Assessment for Safe Product Development
Biosafety studies focus on evaluating the potential risks that biological materials, chemical substances, or medical products may pose to human health and the environment. These assessments are essential for ensuring that products are safe for intended use and comply with regulatory safety requirements.
Our laboratory performs biosafety-related evaluations within a structured quality system aligned with OECD Good Laboratory Practice (GLP) principles when required, ensuring reliable, traceable, and internationally acceptable data.
Scope of Biosafety Evaluation
Biosafety assessment is a multidisciplinary process that examines the interaction between test substances and biological systems. Depending on the product type and regulatory expectations, studies may include:
- Cytotoxicity and cell viability assessments
- Irritation and sensitization potential
- Systemic exposure evaluation
- Microbiological safety assessments
- Contamination and sterility-related evaluations
- Risk characterization of biological hazards
Each assessment is designed to support safe product development and regulatory decision-making.
Risk-Based Scientific Approach
Biosafety evaluations are performed using a risk-based strategy that considers:
- Intended product use
- Exposure route and duration
- Target population
- Chemical and biological properties of the substance
- Existing toxicological data
This approach ensures that testing strategies are scientifically justified and aligned with international regulatory expectations.
GLP-Compliant Study Framework
When required, biosafety studies are conducted under OECD GLP principles with full documentation and quality assurance oversight. This includes:
- Controlled study planning and protocol approval
- Standardized experimental procedures
- Independent Quality Assurance Unit review
- Complete traceability of raw data
- Secure archiving of all study materials
This ensures that biosafety data is suitable for global regulatory submissions.
From Repeated-Dose Toxicity to Carcinogenicity: Long-Term Safety Assessment Using OECD Test Guidelines 407, 408, 452, and 453Under...
OECD Guidelines for Acute Inhalation Toxicity: The Right Testing Strategy Using TG 403, TG 433, and TG 436The respiratory tract is...