Vaccine Research and Production in Pharma Franchise

The function of the vaccine is to enable the body's immune system, to fight and defend our body against a disease. A vaccine is a biological preparation that provides active acquired immunity to a particular disease. Vaccines can prevent or ameliorate infectious disease.

Vaccine development is a long, complex process scientists and medical experts from around the world, it requires years of research and involving a combination of public and private involvement before the vaccine is made available to the general public.

The Pharma PCD adds that general stages for vaccine research and development are:

Exploratory Stage 

This stage involves basic laboratory research and often lasts for several years. Vaccine research is extensive process in which scientists and researchers identify natural or synthetic antigens that might help prevent or treat a disease. Antigens are substances, often a protein, that stimulate the body to produce an immune response to protect itself against attacks from future actual disease exposure.

Pre-Clinical Stage 

Pre-clinical studies involve the antigen testing on animal testing to assess the safety of the candidate vaccine and its ability to provoke an immune response. The test subjects may include monkey and rats. These studies give researchers an idea of reaction expected in humans and suggest the starting dose of the vaccine.

Clinical Development

This involves different phase processes that actually test in humans.

Phase I, small groups of people receive the trial vaccine. 

Phase II, the clinical study is expanded and the vaccine is given to people who have characteristics similar to those for whom the new vaccine is intended.

Phase III, the vaccine is given to thousands of people and tested for efficacy and safety. 

Regulatory Approvals 

Vaccines are tested by the regulatory bodies before actually given to the people for the approval and safety of public. Also, it keeps the track of side effects occurred by the Vaccine. The primary purpose of these bodies is to govern the medicinal products is to safeguard public health. Some of them are USFDA (USA), EMEA (European Union), CDSCO (India).

Manufacturing and Delivery

Vaccines are produced in large scale after the testing and approval to administer the large populations of children and adults. Being a third party manufacturing unit as well , we postulate Good Manufacturing Practices that will involve several quality controls and an adequate infrastructure and separation of activities to avoid cross-contamination. These are then delivered to various clinical stores.

The below steps clearly showcase the vaccine and research production process in a pharmaceutical company.