Monoclonal Antibodies

5.0 Strategic Policy Options

In order to implement the technological alternatives suggested earlier for construction of cell lines and mass production of mAbs, we need to examine some strategic policy options. They are presented below:

Establish a closer linkage between hybridoma laboratories in research institutes, hospitals/clinics and Govt. approved regulatory organizations.

Create a product development cell within established research institutes (having hybridoma labs) to transfer the technology to biotech firms in the industry.

Develop proprietary technology rights and patent rights in order to encourage competitive advantage in organizations.

Fund applied research that would evolve a comprehensive research strategy for the development and transfer of the technology to biotech firms in the pharmaceutical industry.

Canalize imports of raw materials (fetal calf serum) and plastic ware, through central body or institution who will ensure adequate stocks of quality materials acquired at a special price.

Encourage indigenization of technology or import of technology with subsequent indigenization in the area of bio process engineering, raw materials and plastic ware manufacture.

Fund basic research to develop human monoclonals for use in therapy and diagnosis and to overcome technical problems faced in hybridoma technology.

Set up joint collaboration between research laboratories, pharmaceutical companies and Government for upscaling and updating technology especially in mass scale production of monoclonals.

Develop skills of scientists and technicians through a comprehensive training programme at well established research centre.

Foster scientific interaction among clinicians, pathologists, biochemicals and immunologist. This interaction would be necessary to indicate in which are mAbs should be developed and to identify research laboratories that can handle such projects.

Reduce import duties on raw materials and plastic ware used for development and production of diagnostic kits with a condition that supplies to Government hospital for mass screening be charge a special discount price.

Draw up a regulatory framework within which laboratories would be required to enforce strict safety and quality guidelines starting with raw materials used to development of final end product for commercial use in hospitals, clinics and dispensaries around the country.

6.0 Evaluation of the technological options

6.1 Impacts Associated With Hybridoma Technology

An immediate gain will be the replacement of variable and sometime scarce animal antisera. The impacts will be better standardized immunoassays and eventually more economical products.

Rapid diagnosis and subsequent early treatment in the clinic is therefore one of the significant impacts of the hybridoma technology. Rapid diagnosis will enable early treatment thereby saving man hours.

The availability of a large number of specific diagnostic kits will facilitate the task to the general practitioner who will now be able to precisely determine many types of disease, thereby formulating specific therapy without the laborious routine which requires that the patient first be referred to a specialist and then to a pathological laboratory.

The shift in emphasis from therapy (hospitals and drugs) to mass-diffused diagnosis (diagnostic kits) and prevention (vaccines) would lead to reduction in public health costs. According to Prof. Johri, Molecular Biologist at TIFR Bombay, the health costs will rise initially but subsequently decline.

The rapidity, specificity, sensitivity to small quantities of test material (blood, urine), ease of use and low costs will enable the new diagnostic kits to conduct periodic check-ups of individuals and their use can be extended to the entire population.

The hybridoma technology could substantially reduce the cost of developing diagnostic kits if laboratories within the country apply themselves to the task of raising mAbs against specific antigens (especially pathogenic organisms).

The overall impact of early and specific diagnosis coupled with an effective monitoring of therapy will greatly improve the quality of life and have substantial, indirect macroeconomic as well as private economic benefits due to reduction in the number of working days lost through sick leave and the likely prolongation of working life. Improvements in new health-related diagnostics, particularly by monoclonal antibodies which are faster, safer more precise and cheaper than conventional tests, represent a significant improvement in service. The conventional widal test to detect typhoid fever costs around Rs. 30-40/-. However, this test is positive only after seven days of fever and lacks specificity. Moreover, because of high endermicity of the disease, many false positives are also diagnosed.

The diffusion of mass health screening would lead to automation of instrumentation, development of data processing systems and use of telecommunications for transmission of data from laboratories to data processing centers.

The monoclonal antibody technology will have its earliest and greatest impact on the pharmaceutical and health care industry. The market in India by 1991 for monoclonal diagnostic kits is estimated around 100 crores of rupees. This requirement is based on the need for monoclonals to be produced to detect hepatitis B virus, filarion parasites, enteric fevers, pregnancy and cancer.                                                                                                                                                               Back