DEVELOPMENT OF BIOLOGICALS FOR IMMUNO-PROPHYLAXIS AND IMMUNO-DIAGNOSTIC

Background

Recently the livestock sector has emerged as a priority sector. Livestock has been subsistence sector dominated by smallholders to meet their needs of milk, food and cash income on a daily basis. In rural areas, livestock is considered a more secure source of income for the small farmers and landless poor. It has become an important source of employment generation in rural areas. The poverty incidence in Pakistan is determined by income variability and thus livestock is the best hope for poverty reduction as it can uplift the socio-economic conditions of our rural masses.

The agriculture sector provides a livelihood for two-thirds of the country’s population, contributes 19.8 percent to GDP, 60 percent to exports and 42.3 percent to the labor force. Most of its contribution comes from crops and livestock in almost equal proportions. Livestock and fisheries contribute 58.6 percent of the agriculture value-added and 11.6 percent to the national GDP. Historically, it has been a subsistence sector dominated by small and landless farmers to meet their needs for food, draft animals, and some cash income. Nearly 8 million families involved in livestock raising driving more than 35 percent income from livestock production activities (Economic survey of Pakistan 2015-16).

The challenges in the 21st century will be doubling the output of several crops, livestock and fisheries production exclusively through productivity enhancement. It has been planned to apply biotechnology in the livestock sector for genetic improvement of animals in terms of milk & meat production, disease resistance, detection and prevention, vaccine and drug production, etc.

 

 

Description, Justification & Technical Parameters

Pakistan has an agriculture-based economy with livestock an integral part of it and that serves as an important segment of human life focusing on food source in developing countries; more than 70% population of the country is dwelling in the villages and is dependent on agriculture/ dairy farming. Agriculture farmers in villages are smallholders and income from farming is not sufficient to meet their daily requirements. Every family has therefore started a side business of rearing livestock that is highly profitable and is a good source to alleviate poverty amongst the villagers. More than 8.0 million families are directly or indirectly involved in livestock or poultry business. However, the poultry farmers are facing problems of diseases, fodder/concentrate, management, natural disasters, marketing, etc.

There are many infectious diseases that badly affect the profitability of poultry farming. Some of the viral diseases are Avian Influenza (AI) Newcastle Disease (ND), Infectious Bronchitis (IB), Infectious Bursal Disease (IBD), etc are endemic in this country.  All of the viral diseases are highly infectious and sometimes fatal that affects domestic, wild and commercial poultry. AI particularly subtype H5N1 is one of the major trans-boundary animal diseases that can attract international trade embargo to any country. The disease is highly contagious where the virus replicates and spreads rapidly. The serotypes “H7N3”, “H9N2” and “H5N1” of AI were found in Pakistan during the period 1995-2015 (Khawaja et al., 2009 Awan et al., 2009). Serotype ‘H9N2’ was found to be the most prevalent. The disease is characterized by the watery discharge from eyes and mucoid plugs making difficult for birds to respire. Gasping and gaping are the predominant respiratory signs reported in most of the Avian Influenza outbreaks. It causes a reduction in weight gain high morbidity, low mortality, lesions in the oral cavity. The prevalent disease causes heavy economic losses to the poultry industry and severs consternation to the poultry farmers. Sometimes the intensity of the loss is so irreparable that farmers become out of business. The loss is measured in terms of mortality, morbidity, poor feed conversion ratio and cost of treatment. The disease is controlled by stamping out of infected animals, biosecurity measures, homeopathic drugs, passive immunization, and mass-scale vaccination. Stamping out of infected animals is not possible due to the poor economic status of the farmers and the lack of interest of the government for compensation. The bio-security measure is not effective on account of the social behavior of the community. Homeopathic drugs have not yet experimentally proved as an effective way to eliminate the infectious agent. 
The disease status of livestock in any particular country or region may be considered as endemic, sporadic, or free; however, Pakistan is considered endemic to many of the poultry and cattle diseases. Some countries such as the UK, France, and Germany have eradicated these diseases, often following mass annual prophylactic vaccination campaigns and the stringent application of zoo sanitary measures following disease outbreaks.  In this regard, there is a dire need of a state-of-art biologics production unit where required manpower could be trained in the production of vaccine using indigenous isolates or FAO recommended strains and its evaluation, and ultimately that could be utilized or practiced in similar production units in Pakistan in future.

 

Importance of the Project

Livestock contributes a major share in the agriculture sector of Pakistan. The livestock population of Pakistan is 42.8 million cattle, 36.6 million buffaloes, 70.3 million goats, 29.8 million sheep, and 1.0 million camels. These animals are meant for two major categories i.e. production and draught and do yield 54,328 metric tons of milk and, together with poultry, 3,873 metric tons of meat (Economic Survey of Pakistan, 2015-16).  Presently Pakistan’s demand for the vaccine is have not been fulfilled however, together with the government and private sector has a limited annual production capacity. Further, there is an absolute lack of biological production unit that could be utilized as human resource development in Pakistan. So, there is a dire need for the establishment of a WHO-recommended based biological production unit for livestock.

Introduction

Institute of Molecular Biology and Biotechnology (IMBB) and Centre for Research in Molecular Medicine (CRiMM) have setup research innovation and commercialization center as a part of the University of Lahore. The Centre will undertake research and development in the following areas.

Vaccine production is particularly related to disease-causing bacteria and viruses of animal origin.

Production of bacterial and viral antigens and antibodies.

Animal Diagnostics.

Evaluation of the antiviral activity of noval herbal and synthetic products

This activity has been undertaken on the behest of the Higher Education Commission which is motivating all the universities to get involved in research and development particularly in economically important areas for the industrial development of the country. The mission is to promote research activities in the universities for enhancing the quantum of knowledge-based economies in the country. The University of Lahore is fully committed to promote such activities. For this purpose, the university has made a rich investment in purchasing high-quality equipment needed for undertaking research at the highest level. In all the sections of IMBB as well as CRiMM, MPhil and Ph.D. research is being carried out. During the last few years, a substantial number of students have graduated at MPhil and Ph.D. levels in the fields of Microbiology, Molecular Biology, Biotechnology, Biochemistry, Physiology, and Forensic Science. All these disciplines have ramifications for the advancement of Biotechnology.
The university now has the plan to devote substantial resources especially in terms of available manpower and equipment for advancing research projects in such areas which may have a direct bearing on the development of research projects of economic importance. The Institute has a human resource comprising 26 PhDs in various disciplines of modern biology.  In one particular area that is microbiology and immunology, the university is proposing to invest its resources for completing the projects as specified below.
The technologies available for the production of various industrial materials relevant to these technologies will be linked to the website of The University of Lahore.

Projects

Following is the list of industrial projects available for launching by the industrial units interested in acquiring the technologies with the full support of CRIMM, The University of Lahore.

Each technology as specified shall be available to the interested parties on the following conditions:

The university shall be responsible for providing full details of the technology available with the university.

The experts of the university shall be available on request for launching the production of the technology.

All SOPs related to the specific technology shall be provided with full instructions and details.

The products available with the University of Lahore for purchase by the interested parties on such conditions have to be mutually agreed shall be fully supported by the requirements applicable by the Drug Regulatory Authority of Pakistan (DRAP).

All specifications for quality control and quality assurance shall be provided by the university.

Available Technology

Currently available technologies include the following:

Live new castle disease virus-cell culture-based vaccine.

Live new castle disease chicken embryonated adapted virus vaccine.

Inactivated avian influenza H9 oil-based vaccine.

Live infectious bronchitis virus-cell culture-based vaccine.

Inactivated infectious bronchitis disease virus-cell culture-based vaccine.

Inactivated new castle disease virus vaccine.

Inactivated avian influenza bivalent (H7+H9) oil-based vaccine.

Inactivated the whole culture Pasteurella multocida (Type A:1) oil-based vaccine.

Inactivated capsule free fractioned Pasteurella multocida (Type A:1) oil-based vaccine.

Any relevant technologies in this area can be provided by the university on request and at negotiated cost.

 

 

Available Biologics

Following antigens can be made available for use in immunodiagnostics
• New castle disease virus antigen
• Avian Influenza subtype H7 and H9 antigens
• Pasteurella multocida Type A:1 indigenous antigens 
Infectious bronchitis virus Type H:120

Available Facilities

Facilities for the following diagnostic tests are also available
• Haem-agglutination inhibition (HIT)
• Fluorescent antibody technique
• Enzyme-linked immunosorbent assay (ELISA)
• Polymerase Chain Reaction (PCR)
• Complement fixation test (CFT)
• Detection of antigen/antibody through modified techniques of agar gel immunodiffusion (AGID) and virus neutralization test (VNT)  
• Characterization of indigenous wild antigen through PCR using common oligos
• Invitro evaluation of antiviral activity of novel synthetic, natural allopathic and herbal compounds     

Following anti-sera can be made available for use in immunodiagnostics
• New castle disease virus antiserum
• Avian Influenza subtype H7 and H9 anti-sera
• Pasteurella multocida Type A:1 indigenous antiserum 
• Infectious bronchitis virus Type H:120 anti-serum



Centre for Research in Molecular Medicine 
The University of Lahore
1-km Raiwind Road off Defence Road 
Bhoptiyian Chowk, Lahore