Center for Biologics Research and Development
CRI’s Center for Biologics Research and Development (CBRD) was founded with the intention to bridge the gap between drug development at laboratory scale and the clinical use, i.e., from bench to bedside. The development of biologics starts from the generation of cell line that produced biologics of interest, product. characterization, proof of the efficacy in vitro and in vivo, toxicity testing, and clinical studies. The process development and scale up to the production of biologics for clinical use with GMP-compliance is also an important step in the drug development.
The ultimate goal of CBRD is to improve the quality of life of Thai people by enabling accessibility and affordability to high quality biotherapeutics. The disease scope includes cancers, infectious diseases, and rare diseases. The first success case is the development of trastuzumab biosimilar from basic cell line engineering to pilot scale production and preclinical (animal) study. The production scale and clinical study are in the process. Another goal of CBRD is to be a training center for biopharmaceutical industry for CGI students as well as external researchers who interested to re-skill and up-skill in this arena. Collectively, CBRD contributes a supportive role in building research knowledge, develop human resource as well as provide infrastructure capability in an emergency situation to drive Thailand economic growth and pertain biosecurity for a good health and well-being society of Thai people.
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Research & Academic Activities
31 Jan 2023
Biologics, or biopharmaceutical drugs, are promising treatments with low side effects for several diseases including cancer, immunological disorder and infectious disease. The high cost of biologics treatment causing the low drug accessibility and affordability. Each year Thailand imports approximately 500-1,000 million Baht of these products from many foreign sources. CBRD is focusing on translating fundamental scientific research to solve national and global health issues using multidisciplinary cutting-edge technology. Since the pandemic of bird flu in 2004 in Thailand, Her Royal Highness Princess Chulabhorn realized that Thailand was in an urgent need of national health security for self-reliance on therapeutics. Biologics or biological products consist of variety classes of bioactive agents including vaccines, blood products, tissue therapy, cell therapy, gene therapy, and recombinant proteins. CBRD main focus is currently on development of recombinant proteins and biologics with potential to be therapeutics, vaccines, diagnostics, and research reagents. Current focus is primarily but not limited to monoclonal antibody, virus like particle, and recombinant peptide hormone. To ensure the seamless transition and preparation of product pipeline, CRI has integrated all necessary steps required for biologics drug development, which are lead screening, lead identification, lead optimization, characterization assay establishment, efficacy demonstration, process development, and proof of concept study. With the lighting speed of technology shift nowadays, CRI has been invested in state-of-the-art technology for...
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31 Jan 2023
A variety of large bioreactor scales have been utilized ranging from pilot-scale 50L and production scale 200L and 1000L. The downstream process optimizations including chromatography, virus inactivation, tangential flow filtration and normal flow filtration are performed in parallel with upstream process optimization to expedite the timeline for the best benefit for Thai patients.
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Research
Below are the research focuses of Lab Immunology:
1. Development of simple diagnostic tests for antigens/antibodies relevant to health problems in Thailand and other countries.2. Development of in vitro assays to reduce and/or replace the use of experimental animals.
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Activities
23 Feb 2017
Development of a GNA-lectin based immunochromatographic test for rapid diagnosis in human penicilliosis marneffeiPenicillium marneffei is classified as an important emerging opportunistic fungal infection. It has been recently renamed as Talaromyces marneffei. It is the most prevalent systemic mycotic infection in patients infected with human immunodeficiency virus (HIV). This infection is endemic in tropical Asia including Thailand, northeastern India, southern China, Hong Kong, Vietnam and Taiwan. The microorganism is the only known temperature-dependent dimorphic fungus of the genus Penicillium.In the purpose of this study, a novel sandwich ICT for screening P. marneffei antigen in urine and/or serum samples will be developed. The monoclonal anti-P. marneffei antigen gold conjugate will be used as specific signal developing agent and Galanthus nivalis agglutinin (GNA), (or polyclonal anti- P. marneffei antigen) immobilized at test line zone will be used as capturing molecule acting as polyclonal anti-terminal mannose. The diagnostic performance of the novel sandwich ICT strip will be evaluated in comparison to that of the hemoculture-confirmed penicilliosis marneffei which is used as the gold standard laboratory diagnosis of penicilliosis marneffei.
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03 Apr 2014
Recently, there is an urgent need for rapid diagnostic tests for new infectious agents in man and animals. Conventionally, these infectious agents are identified either by culture or by using molecular biology techniques, e.g. PCR. These processes are costly and usually take several hours or even days. We have produced luminol encapsulated biotinylated liposome and used it as a generic signal generator, capable of conjugation to biotinylated biomolecules, such as specific microbial oligonucleotides, antibody and antigen. The system has been used to detect specific oligonucleotide hybridization and specific antigen-antibody interaction, and the results have been published.
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03 Apr 2014
Human pythiosis is an emerging and life-threatening infectious disease caused by the fungus-like organism Pythium insidiosum. It is endemic in Thailand where about 80% of the cases are reported. The disease has high rate of morbidity and mortality, due to lack of early diagnosis and effective treatment. We have developed a convenient and reliable immunochromatographic test (ICT) for rapid detection of human anti-P.insidiosum IgG, for use in early diagnosis and monitoring of pythiosis patients, resulting in saving of limbs and lives. The test kit has been mass produced for free distribution to 6 hospitals with medical schools throughout the country. This research has been published and a patent application has been submitted. In collaboration with researchers from the Department of Pathology, Ramathibodi Hospital, the ICT has been used to study the seroprevalence of P.insidiosum infection in high-risk hematological patients, and a multi-host ICT for the detection of P.insidiosum infection in human, horse and dog has been developed.
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03 Apr 2014
Development of immunochromatographic tests for simple diagnosis of human gnathostomiasis caused by Gnathostoma spinigerumGnathostomiasis is a parasitic infection caused by the third stage larvae of the helminthes Gnathostoma spp., and is found mostly in tropical and subtropical regions. It is a food-borne zoonosis and is endemic in areas where people eat raw freshwater fish or shellfish, especially Thailand and other parts of Southeast Asia, Japan, and increasingly Latin America, particularly Mexico. The common clinical features include an intermittent cutaneous or subcutaneous migratory swelling that may persist for many years. In some cases, the parasite can enter other tissues such as the liver, and the eye, resulting in vision loss or blindness, and the nerves, spinal cord, or brain, resulting in nerve pain, paralysis, coma and death.In this project, we propose to study to produce a recombinant protein from a specific antigen and/or synthesize a specific peptide which will be used as a specific antigen of G. spinigerum and to develop a highly specific and sensitive immunochromatographic test for gnathostomiasis.
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23 Jan 2015
Most antivenoms (AVs) are obtained from the immunization of a large animal (e.g. horse) with only one single venom which resulting to the specific against only a venom, namely monospecific AVs. In case of this AVs, we need to know accurate identification of the culprit snake be bitten. Thus, misdiagnosis could lead to treatment failure and wastage of the expensive AV. To solve this issue, the production of polyspecific antivenom by the immunization with a mixture of venoms from different species of snakes would be useful. Until now, the research on venoms has been continuously developed the efficiency and high dose potency AVs by combination of conventional immunology and advances technology. Therefore, proteomic approach is required for exploration of venom profiles or investigation of the neutralizing toxin by AVs. The challenge of generating effective AVs is universal AV with coverage of all type snakes in a wide geographic area and high efficiency. Furthermore, such AVs would be produced cheaply as a result of economy of scale.
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03 Apr 2014
Snake venoms are produced by snakes for digestion and to rapidly immobilize their prey. Venoms contain various hydrolytic enzymes and toxins e.g., neurotoxins and cytotoxins. Neurotoxic venoms are mainly produced by elapid snakes (cobra, krait, mamba) and sea snakes. These toxins cause neuromuscular blockage, leading to respiratory failure and death. Postsynaptic neurotoxins (PSNTs) from different elapids, although chemically and pharmacologically similar, are immunochemically distinct, so antivenom (AV) against venom from one elapid usually fails to neutralize venom of another elapid, even from the same genus. Thus, each country or region needs to produce its own AV, which is not economically or technically always possible. The lack of effective AVs has resulted in numerous deaths of snakebite victims. Our aim is to produce a pan–specific antivenom against venoms of Southeast Asian elapid snakes. Previously we have established an immunization protocol (WHO Guidelines, 2010), which is highly effective in producing high titer and high affinity antibody against PSNTs of various snakes. Potent polyspecific antivenom has been produced against 3 elapids from Thailand with ED50s comparable to the corresponding monospecific antivenoms. Using this immunization protocol with selected neurotoxins from various elapids, we are studying the preparation of a pan-specific antivenom against elapids of SE Asian countries. If successful, this antivenom could be produced for wide distribution and, with economy of scale, should...
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