Biotechnology Testing

Ensuring Safety

Iskon Biotech specializes in biotechnology testing in the United States. Biotechnology testing is crucial to various industries due to the fact that it assists with quality control, research and development, genetic analysis, environmental monitoring, disease diagnosis and treatment, and food safety and agriculture. Without biotechnology testing, sponsors may not have access to valuable information and insights that would enhance safety and quality standards for their products. Our biotechnological testing services allow companies to have peace of mind knowing their products are safe.

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What Do We Do?

When it comes to biotechnology testing, our team stands at the forefront of your options. We are extremely thorough and well-organized when it comes to testing your products. We will ensure your product has undergone the necessary testing procedures to confirm its safety.

To ensure that products are virus-free, viral clearance studies are required. These studies provide safety data for biopharmaceutical products or medical devices that are derived from human or animal tissues. Our team designs viral clearance studies that comply with the relevant guidelines and standards. For example, our studies follow and use the guidance of the European Note, the Q5 Viral Safety Evaluation, and the ISO 22442-3. These resources are used to verify and provide safety data for biopharmaceutical products or medical devices that are derived from human or animal cells. This data is vital to ensure the removal and inactivation of viruses from the product being tested. Our viral clearance studies will verify the removal or inactivation while confirming the safety of manufacturing processes and final products.

Viral Clearance Services
Viral Clearance Studies
Viral Clearance Kits

An adventitious virus is a virus that unintentionally contaminates a product. Adventitious agents can complicate biopharmaceutical manufacturing significantly. Agents that are adventitious include a variety of lifeforms, such as bacteria, fungi, viruses, mycoplasma, and other lifeforms that are accidentally introduced into biological systems. These agents pose risks and problems for the stability of the cells and the sterility of the manufacturing products.

Virology Testing
In-Vitro Assays
Rodent Virus Testing
Retrovirus Testing
Quantitative PCR Testing for Detection of Adventitious Virus
Electron Microscopy Services

Disinfection qualification is a formal process where the success of cleaning methods and products is tested and checked. This is to ensure that the manufacturing environment is sanitary and sterile so that contamination does not occur by the presence of microorganisms and viruses.

Disinfectant Efficacy and Disinfectant Qualification for Controlled Manufacturing Environments
Disinfectant Qualification Test Methods
Disinfection Qualification for the Pharmaceutical Industry

The Peace of Mind That You Deserve

The importance of biotechnology is undeniable. Due to the fact that biotechnology is a vital component of our everyday lives, it is necessary to have access to biotechnology testing. Our testing services allow you and other sponsors like you to confirm the safety and quality of your product. We follow all necessary and required regulations and guidelines to ensure that your product is free from viruses, bacteria, and other potentially harmful agents. Our team of experts is prepared and equipped to give you the peace of mind you deserve when it comes to your product.

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