building a world class vaccine manufacturing plant in ... · difference between vaccine &...
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Building a world class vaccine manufacturing plant in Bangladesh: Challenges and Opportunities
Abdul Muktadir Secretary General
Bangladesh Association of Pharmaceutical Industries
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Abdul Muktadir Managing Director Incepta Vaccine Ltd
Incepta Vaccine Ltd
B. Pharm (Hons), M. Pharm from University of Dhaka M.S. in Industrial Pharmacy, Long Island University, USA
Research experience on –
1. Anti-tumor antibiotic, University of Dhaka & IPGMR (BSMMU) 2. Dosage Form Design, Long Island University, USA 3. Special research interest on Aerosol, Nanotechnology, Sustain release drug, Lyophilyzation, Design of Pharmaceutical Factory
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What is a pharmaceutical product?
Pharmaceutical products are usually small chemical compounds which have been developed into a dosage form according to route of administration intended for use in -
• Diagnosis, • Treatment, or • Prevention of disease
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Incepta Pharmaceutical Ltd Dhaka, Bangladesh
A private limited company having about 5,000 employees which produces such pharmaceutical products
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GMP approval from various Authorities
UK MHRA GMP
Turkey GMP
UK MHRA GMP certificate
European GMP certificate
Turkey GMP certificate
Kenya GMP certificate
Ethiopia GMP certificate
Uganda GMP certificate
D R Congo GMP certificate
Yemen GMP certificate
Sudan GMP certificate
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Fact Sheet: Incepta Pharmaceuticals Ltd
• Year of Establishment : 1999 • Year of Business Operation : 2000 • Turnover : ~120 million USD • Exporting to : 47 countries
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What is a Vaccine?
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains -
• Weakened or killed forms of the disease-causing microorganism,
• Its toxins or • One of its surface proteins • Others
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Difference between Vaccine & Pharma products in technology
Pharmaceutical products
vaccines
Small chemical molecules
Heat stable (more or less)
Can be processed by terminal sterilization
Large protein molecules Heat labile
Can not be processed by terminal sterilization
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Similarities between Vaccine & Pharma products in technology
• There are some similarity in manufacturing process with pharmaceutical injectable products
• Injectable products which are produced in aseptic filling process requires similar stringent environmental control, i.e class A
• Also, gowning requirement, microbiological testing etc. are somewhat similar
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I N N O V A T I V E C O N C E P T I N T O P R A C T I C E
Incepta Vaccine Ltd
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Incepta Vaccine Ltd
• For catering global need and that of Bangladesh, Human vaccine division “INCEPTA VACCINE LIMITED” emerged.
• It will provide vaccine to vast majority of
population at an affordable cost. • It has state of art facility fully compliant with
WHO-GMP & International Standard • It is a self sufficient unit with its own dedicated
technical manpower, utilities and Animal house.
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Research and Development Block
Antigen Production Block Fill Finish Block Microbiology Lab Chemistry Lab Animal House Day Store Dispensing Area
Incepta Vaccine Ltd has state of the art facility with following areas:
Clean Utility Area Packing and Storage
Area Ancillary Utilities Area Laundry Stability Area & Retained
Sample Area Central Ware House and
Central Power Plant
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Vaccine Production Requires
• Lab for viral & bacterial vaccine development
• Pilot scale GMP facility
• Antigen manufacturing
• Fill Finish
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Research and Development Block
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Lab & Pilot scale GMP Facility
• Fully equipped with production and QC
• Cell Culture for Viral Vaccine
• Fermentors for Recombinant & Bacterial vaccines
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Lay out of R & D Area
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V a c c i n e R & D
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Cell Culture
Lab
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Inverted Microscope
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• Incepta Vaccine Ltd has already launched 3 vaccines:
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Viral Particle analyzer (q-viro-X)
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Mammalian Cell Culture bioreactor
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AKTA analyzer
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Gel Doc XR+
(Gel Electrophoresis)
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Bacteria Handling
Lab
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Fermentation
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Centrifuge & Purification
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Spectrophotometer
Tangential Forward Flow (TFF) system for Filtration
of Protein
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Antigen Production Block
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Antigen Production
• Bacterial Line with 1500 L Fermentor
• Bacterial Line with 750 L Fermentor
• Viral Line with 450 L Bio-reactor
• Each Line is equipped with individual down-stream process
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Challenges
• Lack of Trained Manpower
• Highly Expensive
• Long development process
• Cumbersome approval process
• Cumbersome public purchase process
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Lay-out of Antigen
(Bacterial)
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Lay-out of Antigen (Viral)
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Fermentor for Antigen production (for Bacterial line)
Under construction
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Fermentor for Antigen production (for Rabies) Under construction
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Fill Finish Block
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• Incepta Vaccine Ltd can produce any dose size from 0.1ml to 15 ml, with 4 different products simultaneously and has capacity to fill more then 2,40,000 ampoules and 3,60,000 vials per day.
Incepta Vaccine Ltd - Capacity
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The yearly capacity is 180 million vials and ampoules.
Capacity / Hour
Capacity / Day
Capacity / Year
Vials 18,000 360,000 108,000,000
Ampoules 12,000 240,000 72,000,000
Total capacity per year 180,000,000
Incepta Vaccine Ltd - Capacity
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Fill & Finish
• Washing line
• Lyophilization line
• Filling line
• Packaging line
For fill & finish Incepta vaccine Ltd has 4
manufacturing lines which contains -
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• Four German filling lines have been provided, independent of each other so that four different products can be manufactured simultaneously.
• Each area has been provided with dedicated HVAC
system to prevent cross contamination. • All the filling area rooms are provided with terminal
HEPA filters, with required air changes so as to create Class A, B, C & D environment, as the requirement of GMP.
Incepta Vaccine Ltd – Filling Lines
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• Each filling line is provided with a sterilizing autoclave and decontamination autoclave.
• Each line is connected to
independent visual inspection and labeling machine so as to prevent the chances of cross contamination.
Incepta Vaccine Ltd – Filling Lines
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• The antigens are processed aseptically to produce the final liquid bulk which is then filled into individual vials or ampoules.
• The filling is done as required and vials are stoppered
and sealed automatically and passed to visual inspection and labeling Area.
• Once the QC and QA have released the batch, the material is sent to central depot for further distribution.
Incepta Vaccine Ltd – Process
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• Big packing area, covering around 9,000 square feet.
• Material air lock. Provided with Access control.
• Day cold room with 5 3˚C temperature is provided so as to maintain cold chain during Packing.
Incepta Vaccine Ltd – Packing Area
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• Two -20˚C cold rooms are provided to store finished products and Bulk separately.
• Three 5 3˚C cold rooms are provided. One for storage
of bulk and two for finished product. • All the cold rooms have 5 temperature sensors and two
sensors for Data loggers, so as to monitor Cold chain every minute through wireless receivers.
• Total Capacity to store 500 million doses at 2˚C - 8˚C is
available.
Incepta Vaccine Ltd – Storage
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Quality control is done in 3 steps:
Incepta Vaccine Ltd – Quality Control
• Microbiology
• Chemical Lab, and
• Animal Tests
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• Divided in Infectious and Non-Infectious Area • This Microbiology area is dedicated for Sterility
testing, Endotoxin testing, Bio-burden testing, cell culture testing and all other microbiological testing.
Incepta Vaccine Ltd – Microbiology
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Lay-out of Fill Finish
Production Area
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Lay-out of Packaging
Area
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Lay out of Micro-biology area
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Production area
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Ampoule washing machine, Germany
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Vial washing machine, Germany
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Vial washing machine, Germany
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Rabies filling machine, Germany
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Rabies lyophilizer machine
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Vial filling machine, Germany
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Vial sealing machine, Germany
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Ampoule filling machine, Germany
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Dry heat sterilizer, Italy
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Roll label machine
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Fill Finish Facility, Challenges
• Requires processing of Heat Labile substances
• Aseptic Procedure
• Does not allow long room temperature exposure
• Some products require Lyophilization
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Fill Finish Facility, Challenges (Cont.)
• Small Fill volume requires Precision filling 0.01 ml level
• Huge quantity of WFI
• Class 100, 10,000, Clean Room
• Highly Expensive
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• Largest lab animal house in Bangladesh covering around 24,000 square feet area.
Animal House
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Rabbit Guinea pig
Animal House
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• The Animals are provided with 12 hour day light and 12 hour dark cycle and are maintained at comfortable temperature at 23 2 C and Relative Humidity at 50%.
• All area are supplied with dedicated HVAC system to prevent cross contamination.
• Bio safety level 3 standard lab for testing various vaccines which involve challenge with infectious organisms.
Incepta Vaccine Ltd – Animal House
• Can hold 6 various species of lab animals without any cross contamination.
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• Incepta Vaccine Ltd has already launched 4 vaccines:
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1. Tetanus immunoglobulin
2. Haemophilus influenzae b (HIB)
3. Meningococcal
4. Measles & Rubella
5. Polio
6. Pentavalent (DPT,HIB,HB)
DPT: Diphtheria, Pertussis, Tetanus HIB: Haemophillus influenzae b
HB: Hepatitis B
A number of exciting vaccines are in pipeline:
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Incepta Vaccine Ltd can become a global supplier of high quality vaccine
90 M
180 M
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Yearly Requirement ofBangladesh
Incepta vaccine Ltd'scapacity
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Every year Bangladesh Government has to purchase more than 90 million doses of different vaccines for Expanded Program on Immunization (EPI) for children of 0-1 year.
In private sector other than EPI, every year more than 30 million doses are required.
Incepta Vaccine Ltd is poised to supply world class vaccine at affordable price
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Thank You