HLL’s Experience:

Vaccine Plant

-in Public Sector-

Raman K Ramachandran,

CEO, HLL Biotech Limited

5th Annual Vaccine World India Summit, Pune

The starting Point

Purpose

“To Provide High Quality

Healthcare Products & Services

at Affordable Price”

Business Purpose

48 years of existence

Hindustan Latex Ltd. incorporated in 1966 – mandated to supply condoms for the National Family Welfare Program

Condoms till 1980

Other contraceptives by late 1980’s

Medical Devices by

1990’s

Innovation & Marketing – Key strategy to growth

Transition

Services 2000’s

Business Overview

IUD

Blood bags

OCP/ ECP

Healthcare

Services

Procurement Consultancy

Condoms (Male & Female)

Hydrocephalus Shunt

Sutures Infrastructure Consultancy

Diagnostics Services

Vaccines / Injectables

Tissue Expander

Tubal Ring Rapid Test Kits

Hospital

Products

Contraceptives

& Pharma

70 plus Powerful Brands

HLL Group

Issue dated Nov 14TH – 20TH 2009

“the rebranded Hindustan Latex shows how public enterprises can evolve, if given the freedom to do so…...”

“ Its concern for customer choice resembles that of private company”

HLL ENTRY - VACCINES

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HLL entry in to vaccine based on Corporate Vision Plan prepared by

E&Y.

Phase wise entry

Phase I : Marketing of vaccines

• Marketing of Hepatitis B , Typhoid and Rabies vaccine procured

from other manufacturers.

• Procurement agency for supply of JE vaccine for GOI

program.

Phase II : Filling & packing of vaccine bulk procured from other

manufacturers.

Phase III : Manufacturing of bulk vaccines

HLL IN VACCINES

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PROJECT MANAGEMENT & ENGINEERING

HLL as Project Management Consultant for revival of Government

vaccine Institutes to cGMP compliant.

CRI , Kasauli –DPT group of vaccine

BCG vaccine Laboratory, Guindy :BCG vaccine

Pasteur Institute of India, Coonoor : DPT group of vaccine.

REVIVAL OF CRI, KASAULI

• 100 yrs old vaccine research and production unit for DPT and other

vaccines under Ministry of Health & family welfare, GOI

• Revival of the existing facility for DPT group of vaccines as per

cGMP compliance.

• HLL – Project Management Consultant

• Concept to Commissioning & Validation

• Engineering & GMP consultant : NNE Pharmaplan

• Established new cGMP compliant facilities.

• Certification from National Regulatory Authority – GMP compliance -

Received

• Installed Capacity : 100 Million Doses/annum

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New cGMP facility for DPT group of vaccines

3/9/2015 16

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Clean room facility Microfiltration System

WFI generation systems Bioreactor

PASTEUR INTITUTE OF INDIA, COONOOR

• Pasteur Institute of India, Coonoor- started functioning as Pasteur

Institute of Southern India on 6th April 1907.

• Registered as a Society under the Societies Registration Act, 1860

Renamed as Pasteur Institute of India- started functioning as an

autonomous body under the Ministry of Health and Family welfare,

GOI from 10th February 1977.

DPT GROUP OF VACCINES – cGMP FACILITY

• HLL - Project Management Consultant

• Engineering consultant : NNE Pharmaplan

• Revival of DPT group of vaccines manufacturing facility.

• Existing facilities for production & support units very old.

• New facilities for production, formulation, testing and etc – Green

field project.

• Turn key services – from concept to commission & validation.

• Installed Capacity : 135 Million Doses/annum

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GMP FACILITIES – UNDER CONSTRUCTION

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REVIVAL OF BCG VACCINE LABORATORY, CHENNAI

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New cGMP Facility - BCG vaccine : final stage of mechanical completion

• HLL - project management consultant

• New facilities for production & formulation of BCG vaccine as per

cGMP compliance.

• Installed Production capacity : 80 Million Doses/annum

• Turn key services – concept to commissioning & validation

• Mechanical completion : March 2015

• Procurement & installation of equipment- nearing completion

• Facility Validation - Initiated

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• State of the art vaccine manufacturing and research facility to

strengthen vaccine security.

• GOI approval for IVC project : Received on 4th May 2012

• Declared as “ A Project of National Importance” by GOI

• Objective: “To make cost effective vaccines available for the

immunization program”

• Project Funding : GOI

• Project Location : Chengalpattu, near Chennai, Tamil Nadu

INTEGRATED VACCINES COMPLEX (IVC)

• HLL Biotech Limited (HBL) formed on 12th March 2012 to implement

IVC.

• 100% subsidiary of HLL .

• Corporate office : TICEL Biopark , Chennai

• Strives for Affordability, Availability & Accessibility of vaccines.

HLL BIOTECH LIMITED

HLL- Strengths

• Expertise in project management & engineering

• Execution of 3 vaccine projects

• Marketing of vaccines

• Engineering & GMP consultant – in place

• Concept to commissioning & validation

•GOI allotted 100 acres of land at Chengalpattu , near Chennai for setting

up IVC.

•Project execution as per cGMP requirements.

•Lab scale process development : In progress.

•Project Completion including validation : September 2016

•Project Consultant : NNE Pharmaplan India Ltd

IVC

PRODUCT MIX

IVC- SITE PLAN

DESIGN FEATURERS

• Dedicated production suits for each bulk- vaccine

• Formulation blocks - bacterial & viral vaccines

• BSL II design

• Spine concept of construction - connecting different blocks/units

• Support facilities – Dedicated units

• Animal breeding & experiments- Dedicated facilities

• Centralized change room facility

• Centralized QC lab facility

• Dedicated QA unit

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PUBLIC –PRIVATE PARTNERSHIP

• Public-private partnerships- successful model for growth

• Introduction of new technologies in public sector

• Make available cost effective vaccines

• Support immunization program of Governments

• Increase vaccination coverage

• Self sufficiency – vaccine capacities

• Assimilation of technologies & technology transfer

• Procurement of bulk- filling & packing

PARTNERSHIP MODELS-IVC

Partnership : Public – Public partnerships

•Synergy with other government vaccine institutes.

•Supply of bulk to IVC for formulation.

•Technology transfer- bulk manufacturing

Partnership : Public- Private (domestic & international) partnerships

•Technology transfer : vaccine bulk manufacturing

•Loan license : manufacturing

•Procurement of bulk : Filling & packing.

THANK YOU