The case for biologics

For most women, a diagnosis of breast cancer means weeks of chemotherapy, radiation and in many cases a lumpectomy or mastectomy with no guarantee that the disease won’t return down the line.
For those with HER2-positive metastatic breast cancer, the prognosis is particularly worrying, as the drug of choice, trastuzumab, used both with and without chemotherapy, is often too expensive for the patient to afford. 
However, under the leadership of Her Royal Highness Princess Chulabhorn, Thais afflicted by HER2-positive breast cancer will soon be able to receive a biologic trastuzumab monoclonal antibody treatment at an affordable price as Thailand moves towards industrial-scale production of the treatment. It is expected to become widely available within the next three years.
For the past decade, dedicated scientists with the Biotherapeutic Research Centre of the Chulabhorn Research Institute (CRI) have been focusing on the development of biologics and establishing know-how in the design and construction of recombinant DNA, cell line engineering and process development on a commercial scale. 
For the first product in the pipeline, CRI has developed a biologic for the treatment of breast cancer patients who are HER2-positive. 
The biologic is bio-similar to the trastuzumab monoclonal antibody, a man-made antibody that has proved effective in women over-expressing the HER2 protein in the tumour cells. About 25 per cent of breast cancer patients carry this gene and are considered HER2-positive. 
The institute started from the design of the DNA encoding trastuzumab and achieved a cell line that produces a highly similar monoclonal antibody to trastuzumab and with good yield. 
Now the institute is ready to boost the process to an industrial scale. For this it will partner with the National Biopharmaceutical Facility at King Mongkut’s University of Technology Thonburi, which has experience in the process development of biologics at an industrial scale and also boasts a production facility that complies with Good Manufacturing Practice standards. Clinical studies will follow to ensure the biologics are indeed safe for human use. 
Extensive quality control assays are implemented at every production step to ensure the productivity, recovery and quality of biologics and that the product meets relevant international standards and guidelines. 
Thailand currently imports most biologics and in 2012 spent Bt20 billion on them. For this reason alone, the successful production of the trastuzumab monoclonal antibody will play an important role in firming the country’s national drug security while also reducing the cost of biological drug treatment. 
A biological product is defined as a product that contains bio-molecules, especially protein and carbohydrate. Such products include vaccines, blood product, cell or gene therapies, and recombinant protein. 
Princess Chulabhorn, herself a prominent scientist, founded the Biotherapeutic Research Centre to focus on developing biological products. For this, she sought collaboration with the Massachusetts Institute of Technology (MIT) in the United States and has since led researchers and senior officers to study the work of MIT and other leaders in the production of biological drugs in India and the US. 
Products in the pipeline at CRI include novel biologics for the treatment of many cancers, as well as infectious and rare diseases.