1. Introduction

Biological Production Division is the sole producer of life saving vaccines and anti-sera for immunization and therapeutic use to control the communicable diseases in the country. This division is one of the major revenue-generating components of NIH. Through these revenues the institute not only supports the significant expenditures of this division but also operational expenses of its various other divisions and sub-divisions.

The vaccines produced here are the major tools used for the prevention of communicable diseases such as Cholera, Typhoid, Measles, Rabies and Tetanus etc. and are available at affordable prices to the people of Pakistan. Similarly anti sera produced are used for the treatment of snakebite and animal bite. Oral rehydration salt is produced to counter the diarrheaal diseases.

2. Objectives / Targets:

	To produce vaccines and anti sera of assured quality for the people of Pakistan at affordable prices.
	To achievement self-sufficiency and self-reliance in vaccine and sera production to fulfill the requirements of the country.
	To be in line with the current good manufacturing practices (cGMP) and to achieve these targets, work is underway to improve the production facilities through equipment up-gradation, capacity enhancement, manpower training, human resource development and commercial approach.
	In order to update knowledge of its staff regarding the ever-changing requirements of high tech vaccine production, the division holds lectures and officers / technicians are sent abroad for training through IDB, WHO and JICA. In addition, the officers and officials of the institute  also participate in the capacity building workshops organized by other departments.

3. Mission

Manufacture of prophylactic vaccines, therapeutic anti-sera and Nimkol (Oral Rehydration Salt) for treatment and control of communicable and Diarrhoeal diseases and its supply to Government hospitals/dispensaries, Armed forces, EPI and other private organizations.

Name of Vaccines and Sera Produced:

Bacterial Vaccines:

	Tetanus Toxoid (Adsorbed)
	TAB: Typhoid-Cholera (Mixed)

Viral Vaccines:

	Oral Polio (OPV)
	Measles
	Rabies(Sheep Brain)

Anti-Sera Against:

Snake Venoms (polyvalent)

AAAA	Cobra (Naja naja). Echis Carinatus. Russel's Viper. Krait (Ceruleus Bungarus).

Rabies virus.

Other Products:

	Allergen Extracts (vaccine)
	Oral Re-Hydration Salt

3. Manufacturing Strategies

Shared Production:    Formulation, processing, filling and packaging from imported concentrates of Tetanus Toxoid.

Basic Manufacture:  From raw materials using seed virus and bacteria of Measles, Typhoid/Cholera;
Rabies, Snake Anti-venom, Rabies Anti-Sera and allergen extracts (vaccines)

4. Setup of Production & Related Departments

Quality Assurance Department: Independent Quality Assurance Department oversees the production and control activities along with implementation of current GMP, GLP, GDP etc.  

Quality Control Laboratory: It is responsible for testing of the raw materials and the manufactured vaccines and anti-sera.

Animal House: Experimental animals such as mice, rats, rabbits and guinea pigs are provided by the Animal House, which is self-sufficient having excellent breeding facilities.

Central Engineering Department (MSD): It is also available for operation, preventive maintenance and repairs of equipment, machinery and other services.

Human Resources:   About 26 officers and 212 supporting staff personnel are available for vaccine production, quality control, quality assurance and animal house activities.

Capacity of Vaccine, Anti-Sera & ORS

5. Performance / Achievements

	WHO assessment in January 2003 has declared production units as potentially viable.
	Independent Quality Assurance Department established in 2002 to check on GMP, GLP and GDP.
	Construction of new cGMP compliant Sera Processing Laboratory has been started this year (2009).
	An amount of Rs. 93.753 millions revenue is generated through sales of vaccine and anti-sera which is a major contribution towards the NIH budget.

6. Collaboration with International Organizations

BPD has working collaboration with following international organizations:

	WHO
	IDB
	JICA

7. Programs & Projects

	PC-I for the establishment of New cGMP Compliant Facilities for Vaccines at cost of Rs. 1198.705 millions has been prepared and submitted to Ministry of Health for approval.
	PC-I for establishment new Sera  Processing Laboratory is under implementation
	PC-Is  for  improvement and up-gradation of Measles Vaccine Production Laboratory and Cell Culture Rabies Vaccine Production Laboratory are under implementation

8. Future Plans / Goals 

	Implementation of current good manufacturing practices (cGMP), good laboratory practices (cGLP) and good storage practices (cGSP).
	Development of local expertise in vaccines and sera production with the collaboration of leading vaccine manufacturers such as China, Cuba, Indonesia, Iran and Egypt etc.
	Up-gradation and improvement of the available technologies and strengthening of Quality Assurance capacity.
	Acquisition of new vaccine production technologies.

Production & Supply of Vaccine & Anti-Sera From July 2008 to June 2009: