Biologics, or biopharmaceutical drugs, are promising treatments for several diseases including cancer. Following patent expiry of many biologics, biosimilars have been developed to provide patients more access to lower-cost, life-saving medicines. Each year Thailand imports approximately 500-1,000 million Bath of these products from many foreign sources. The quality of biosimilars may not be the same as structures of biological molecules are highly complex, and slight variations in manufacturing processes can cause alteration in efficacy and toxicity of the drugs, potentially leading to serious health complications.

    As our country is progressing towards establishing biopharmaceutical industry, the main objectives are to build capabilities critical for production of quality drugs that are safe and become available as less-expensive alternative drugs for Thai patients, and develop knowledge for quality assessment of biopharmaceutical drugs sold in Thailand.

    Stringent quality control process is key to the success of drug development. Optimization of parameters in the upstream & downstream processes and pre-clinical testing of safety, toxicity, purity, potency, efficacy and physicochemical properties are to ensure safety of a drug prior to clinical trial phase. As Good Laboratory Practice (GLP)-compliant facilities, Laboratory Animal Unit (AAALAC accredited GLP) and Food and Drug Quality Unit (FDQ) are established with standardized and validated techniques for quality control of biopharmaceutical drug development process.