hll’s experience - imapac · hll’s experience: vaccine plant -in public sector- raman k...
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HLL’s Experience:
Vaccine Plant
-in Public Sector-
Raman K Ramachandran,
CEO, HLL Biotech Limited
5th Annual Vaccine World India Summit, Pune
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
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 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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• 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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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
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.