Safety Evaluation

The nonclinical safety evaluation of oligonucleotide therapeutics is basically similar to that of small molecule chemical drugs, mainly including genotoxicity, immunotoxicology, reproductive toxicity, and safety pharmacology evaluation. The reference technical guidelines include the relevant guidelines for drug safety evaluation of The State Drug Administration, United States Food and Drug Administration (US FDA) and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). However, oligonucleotide therapeutics also have their own characteristics. Their toxicity comes from both on-target toxicity caused by pharmacological amplification, and off-target toxicity caused by binding to homologous RNA sequences or their own physical and chemical properties. Therefore, the toxicology study of oligonucleotide therapeutics cannot completely replicate the requirements of the safety evaluation of biological products or chemical drugs.

Alfa Chemistry has a dedicated technology platform for safety evaluation of oligonucleotide therapeutics, providing customers with safety evaluation services, including genotoxicity, immunotoxicology, reproductive toxicity, safety pharmacology evaluation. If you are interested in safety assessment of oligonucleotide therapeutics, please click the link below to learn more.

Genotoxicity Evaluation

Alfa Chemistry attaches great importance to the genotoxicity evaluation of oligonucleotide therapeutics.

Immunotoxicology Evaluation

Immunosuppression, immunostimulation, hypersensitivity, and autoimmunity are the four main aspects of immunotoxicology evaluation.

Reproductive Toxicity Evaluation

Reproductive toxicity evaluation is conducted to identify the hazards of oligonucleotide therapeutics for pregnant and lactating women, as well as women and men of childbearing age.

Safety Pharmacology Evaluation

We have extensive experience in the details of safety pharmacology evaluation of oligonucleotide therapeutics.

Our products and services are for research use only and cannot be used for any clinical purposes.

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