Monoclonal Antibodies


7.3 Identification of R&D centers to transfer the developed technologies to industry

The following institutions could be entrusted the responsibility for producing monoclonal antibodies to be subsequently transferred to the pharmaceutical / biotech industry for packaging and sale.

1) Cancer Research Institute, Bombay: Monoclonals against cancer markers CEA, AFP.
2) NII, New Delhi: Monoclonals against enteric fevers, pregnancy, hepatitis B virus and blood group antigens.
3) Cancer Research Institute, Madras: Monoclonals against cancer markers AFP.
4) Hinduja Hospital and Medical Research Centre, Bombay: Monoclonals against haemopoietic lineage associated markers and thyroid antigens.
5) BAIF Development Research Foundation, Pune: Monoclonals against FMD, RP, IBR
6) MKU University, Madurai: MAbs to detect leprosy.
7) P.G. Institute of Biomedical Sciences, Madras: Monoclonals against hepatitis B virus.
8) TIFR, Bombay: MAbs for large scale therapeutic use with the aid of r-DNA technology.
9) ICGEB, Delhi and CCMB, Hyderabad to develop transgenic plants and human monoclonals.

IMTECH, Chandigarh and NCL, Pune can be asked to develop bioprocess engineering technologies and mAbs for industrial purification. NII, Delhi should be assigned the task of doing basic research in hybridoma technology in order to overcome the technical problems associated with the technology.

BAIF Development Research Foundation, Pune may be considered for taking up large scale production of monoclonal antibodies in their Animal Health Division where fermention and laboratory space with back-up equipments are available. Besides the expertise and learning experience in handling cell lines can be exploited to a tremendous advantage.

7.4 Policies to promote the implementability of the preferred options

(i) Import, technology transfer and joint ventures

Government should encourage imports of patented ENCAPSEL or Hollow fiber continuous flow mass culture technologies and also reduce import duties on encapsels/hollow fibers. This will facilitate large scale production of monoclonal antibodies and r-DNA products. Technology transfer from research centers in India need to be encouraged. This can be done through venture financing (low interest rates on loans), special tax concessions, reduction in import duties on equipment, raw materials and plastic ware, increase in duties on imports of diagnostic kits, and canalization of imports of raw materials (fetal calf serum) and plastic ware through a government agency. Joint ventures with existing companies aboard for particular products or process can also be considered.

(ii) Internal R&D

Government would need to fund basic research to i) develop human monoclonals for use in therapy ii) produce transgenic plants for large scale production of monoclonals iii) develop efficient, indigenous bioprocess engineering technologies and iv) overcome problems faced in existing hybridoma technology. For this a yearly investment of 5 crores of rupees need to be set aside by the government. Secondly, government funded R&D units should be allowed to patent the technology developed. These proprietary technologies can be transferred to industry at a transfer fee and some royalty on sales. Income so obtained can then be used to update the technologies. This would encourage closer links with industry.

Government may also fund applied research. Such research institutions would need to evolve a comprehensive research strategy for development and transfer of technology to biotech firms in the industry. However, it would be desirable if such research is sponsored by firms in the industry and strengthened by close interaction with technical and marketing consultants who will provide marketing, research and technology evaluation inputs. Scientific researchers assigned the projects should be given complete control of projects and finances.

(iii) Regulatory frame work

The government should draw up a regulatory framework and appoint agencies which will have representation from research institutions, users and industry to enforce strict safety and quality guidelines at all levels of development and manufacture of mAbs (raw materials, clinical trials, scaling up, quality control). Safety guidelines should be linked to the updation of the laboratories and penalties need to be raised b the inspecting authority.

(iv) Inter-organizational linkage

It will be necessary to establish closer links between hybridoma laboratories, hospitals/clinics and government approved regulatory organizations to ensure product development, commercialization and its continuous improvement. Joint collaborations between laboratories and industry would need to be set up for the purpose of up scaling and updating technologies developed by such centers. It would also be necessary for research institutions involved in basic and applied research to define and strengthen relationships with international research institutions by publishing research papers aboard, inviting scientists for seminars and workshops and making periodic visits to key research institutions abroad. There is a strong need to encourage scientific interaction among clinicians, pathologists, biochemists and immunologists.

In order to avoid duplication of work at various research centres in India and also to facilitate a kind of coordinative and co-operative mechanism, a study needs to be commissioned by TIFAC or DBT aimed at examining and compiling data on the ongoing work at all te active research centres in the field of veterinary and human disease diagnostics. It is also necessary that an expert committee be formed to resolve issues of cooperation and coordination inn this highly specialized field.

(v) Development of supporting ancillary industry

The ancillary industries need to be geared up to supply packaging material, plastic ware (for example polystyrene ELISA plates, micropipettes) and fetal calf serum. Special tax incentives should be provided by the government to such entrepreneurs involved in providing support services to the biotech firms producing monoclonal kits at an economical price.

(vi) Development of human resources

It would be necessary for some established research institutes like MKU, Madurai, NII, Delhi, CRI, Madras and Bombay to conduct comprehensive training programmes in order to equip technicians and scientists with skills that would enable themselves to confidently handle any problems concerned with the development of monoclonal antibodies and preparation of the diagnostic kit. Training would also be required for medical personnel at primary health centres and clinics/hospitals in order to perform the ELISA test and thereby use the diagnostic kit at their respective units. ELISA READER, microscope and reference album will have to be provided to these centres to facilitate ease of use of the kits.

(vii) Role of financial institutions

Financial institutions should come forward with major equity participation in financing of risk capital projects to enable scientists entrepreneurs to set up biotech firms with indigenous technology for producing diagnostic kits. Long term loans could also be provided at a concessional rate of interest. Equity of financial institutions could be diluted after the project realizes its full economic potential. Any gains that accrue from such an association could be reinvested in centers that would promote utilization of indigenous technology or in providing funds to research institutes for updating technologies.

(viii) Role of pharmaceutical industry

Firms in he industry should have its own R&D and/or would need to sponsor R&D in research laboratories on a continuing basis. Technologies development or acquired need to be productionised by industry in close collaboration with research and regulatory organizations and end users.

(ix) Role of professional and trade associations

Biotech seminars and trade exhibitions can be organized every year to bridge the gap between laboratory, industry end users (clinics, dispensaries) and ventures financiers. Association of the pharmaceutical industry could help in drawing up safety and quality guidelines and in providing a representation to a government cum industry sponsored agency.