Vaccine Formulation Plant

Lalru, Punjab, India

This facility has been set up to manufacture recombinant Hepatitis B Vaccine along with other products
using recombinant DNA technology for filling, packing and final processing. This facility is spread over 50
acres and the complex also houses facilities for Research and Development Laboratories, Animal House
and Effluent Treatment Plant.

The manufacturing facility includes physically segregated Upstream processing area, Down stream
processing area, Formulation area, Cold rooms and Critical systems & utility area. The premises is
designed, constructed, adapted and maintained to suit the production of recombinant vaccines following
current Good Manufacturing Practices (cGMPs). The layout and design aims to minimize the risk of errors
and permit effective cleaning and maintenance in order to avoid contamination, mix-up, and unidirectional
personnel and material flow. Separate cold rooms are provided for the storage of in process and the
finished products under quarantine and release.

Upcoming Facilities

 State-of-the-art manufacturing facilities for Bacterial Product vaccines.

 Facility for Cell Culture based vaccines.
 Upcoming Fermentation based Pilot Plant for scale-up studies of new vaccines and
biopharmaceutical
 A new Vaccine Formulation and Filling Unit under construction to meet requirement of
final product filling and packaging.

 Manufacturing

Overview

Facilities

Services

Capacities
 Quality

Partnering

Contact Us

Panacea Biotec is a leading research driven health management company manufacturing and marketing
vaccines, pharmaceuticals and biopharmaceutical products. We have dedicated R&D centre(s),
manufacturing plant(s) and marketing team(s) for the above businesses.

We provide complete product development, manufacturing and packaging services for solid, semi-solid
and liquid finished dosage forms as well as specialized forms in controlled/sustained release and soft
gelatin finished dosages.

We have state-of-the-art infrastructure and our plants are built to meet EU, US and Japanese market
standards. With a manpower of 2000+ staff we are geared to provide quality products, on-time delivery,
flexible manufacturing and excellent responsiveness to customer’s needs.

We have a proven track record in

 Product development, novel drug delivery system based products, peptides, vaccines, OTC
products and branded generics
 Technology transfer aided by skilled scientific personnel and experienced manufacturing teams
 Manufacturing of finish dosage forms using various technologies – bilayered, tablet in tablet, film
coated, enteric coated, sugar coated, sustained released, chewable, mouth dispersible tablets,
tablet in capsule, gels, liquids, soft gels, hard gelatin capsules
 Joint venture operations/Strategic alliance, research collaborations, technology transfers,
licensing

MANUFACTURING
   

SERVICES  Manufacturing

 Research & Development Overview

 Pharmaceuticals Facilities
 Vaccines
Services
 
Capacities

Research & Development Quality

Partnering
At Panacea Biotec, the quest for the unknown never ends. The belief
that there is a newer therapy or a better drug delivery system just Contact Us
waiting to be discovered is the entrepreneurial spirit behind every
business decision we take.
A significant portion of our turnover is invested in Research & Development
and our current R&D infrastructure is spread across three state-of-the-art
R&D centres driven by the intellectual capabilities of 200 scientists. Our
research facilities are self-reliant with all requisite infrastructures for
research in drug delivery, synthetic chemistry, natural products, animal
studies, analytical and stability testing. A government approved ultramodern
animal house facility is available in-house for pharmacological studies.

Panacea Biotec is supportive of research collaborations with both academic

institutions and research oriented pharmaceutical / biotech companies. Our
contribution to collaborative research projects are focused on areas like:

 Formulation design & optimization based on in-vitro & in-

vivo studies
 Analytical and bio-analytical method development and
validation
 Pharmacokinetic & pharmacodynamic studies in animals
 Stability studies, impurity profiling & synthesis
 Development of synthetic processes and custom synthesis
of molecules

Pharmaceuticals

Our manufacturing expertise lies in various solid, semi solid & liquid dosage
forms such as :

Oral/Solids:

 Conventional tablets/capsules
 Controlled/delayed release / enteric coating tablets and
capsules
 Tablet in Tablet
 Tablet in Capsule
  Multi Layered Capsules
 Hard gelatin/Soft Gelatin capsules
 Mouth Dissolving / Chewable Tablets
 Over-encapsulation
 Coating: film, sugar and functional
 Taste masking, fast-dissolving tablets

            
 
Semi-solids and Liquids:

 Ointments/Creams/Gels
 Suspensions/Syrups/Solutions

Capabilities include large capacity granulation, fabrication and blending,

tableting (chewable, coated, enteric, slow release, bi-layer), coating,
packing, encapsulation as well as automatic filling & packing for liquid orals
& semi solid dosage forms.

At Panacea Biotec, we have dedicated a team of packing experts who look

into every aspect of this final stage before the products leave for their
destinations. The packaging section in the pharma unit houses seven high
speed, versatile packing lines to run on various materials like ALU/PLC,
ALU/ALU, ACLAR, triple laminate, ALU/PVDc coated PVC etc. In blister
packing both types of machines are provided i.e. flat forming / flat sealing
and rotary forming / rotary sealing. Online camera systems are installed for
detection and rejection of empty pockets / broken tablets along with online
pinhole detection, pharma code readers and integrated cartonator
machines, online batch coding, check weighers and BOPP taping machines.
We also have the provision for strip packing and bulk packing.
Ointment department is equipped to handle various formulations e.g.
transdermal drug delivery system in the form of gel and other external
preparations. It is provided with fully automatic lami tube filling line inbuilt
with tube cleaning, filling, sealing and embossing stations integrated with
online cartonator, online batch coding and checkweighing system. All the
manufacturing and filling operations in ointment section are carried out in
class 10000 area.

Similarly, our liquid line is provided for syrup/ suspension/ solution with fully
automatic line for bottle washing, filling and capping and with self-adhesive
label, with online batch coding for Glass / PVC / PET bottles.
 

Vaccines

Panacea Biotec currently manufactures the following vaccines

Recombinant vaccines

 Recombinant Hepatitis B vaccine (Hepatitis B surface

antigen) manufactured using recombinant Pichia pastoris
yeast.

Combination vaccines

 Easyfive - Pentavalent vaccine (Diphtheria Toxoid +

Tetanus Toxoid + Inactivated W.B Pertussis + Hepatitis B
surface antigen + Human Influenza Type b oligosaccharide)
  Ecovac4 - Quadruple vaccine (Diphtheria Toxoid + Tetanus
Toxoid + Inactivated W.B Pertussis + Hepatitis B surface)
 Easyfour - Tetravalent vaccine (Diphtheria Toxoid +
Tetanus Toxoid + Inactivated W.B Pertussis + Human
Influenza Type b oligosaccharide)

Cell culture based vaccines

 Oral Polio Vaccines (Trivalent, Monovalent – Type I & Type

III)

We can offer our services for manufacturing Cell Banks of Bacteria and
Yeast in a cGMP facility. We also manufacture bulk recombinant vaccine
where the antigen is expressed on bacteria or yeast. We have state of the
art facilities, equipped with qualified equipment where Upstream Processing
as well as Downstream processing of any recombinant product can be
carried out under controlled environment.

For filling operations, we have a WHO pre qualified facility at New Delhi
where we can fill any injectable preparation in vials. As a capacity building
measures, a new pilot plant is under construction for testing of new potential
fermentation based products.
Logistics

Besides this, we also have the expertise in cold chain management for the
storage and distribution of vaccines under monitored conditions using a
system of Vaccine Vial Monitors, Data Loggers, Ice Boxes, Coolant, Cold
Rooms & Refrigerated Vehicles.
Manufacturing

   

CAPACITIES  Manufacturing

Pharmaceuticals Overview

Facilities

Tablets 900 million tablets per annum Services

Capacities

Hard Gelatin Quality

120 million capsules per annum
Capsules
Partnering

Soft Gelatin Contact Us

120 million capsules per annum
Capsules

Ointments/Gel 12 million tubes per annum

Liquid Orals 1.2 million litres per annum

Herbal/Dietary 60 million tablets

Supplements 150 million capsules
Vaccines

 Existing capacity of 3.25 million vials per annum

 Upcoming capacity of 300 million doses of liquid vaccines
and 45 million doses of lyophilized vaccine doses per
annum.

Manufacturing

   

QUALITY  Manufacturing

Overview

Facilities

Services

Capacities

Quality

Partnering

Contact Us

Quality Control
Each facility in Panacea Biotec has a full fledged in-house Quality Control
facility comprising of various labs such as wet lab, instrumentation labs,
atomic absorption spectroscopy lab, dissolution lab, stability lab (with
incubators to carry out stability as per ICH guidelines) and packaging material
testing lab. Additionally the vaccine units have labs for molecular biology,
media preparation, sterility testing and radioactivity.

The Quality Control facilities also have a fully self-contained Microbiology lab
to carry out tests for microbial counts, testing of finished products,
microbiological assays and environment controls in the facility.

Each facility has the expertise in various analytical techniques aided by

sophisticated instrumentation, which are best in their class. HPLC from
Agilent, GC Headspace, Atomic Absorption Spectroscopy, FTIR, UV/Visible
spectrophotometers, walk in stability chambers with automatic controls,
Polarimeters and several automatic dissolution test apparatuses.

Quality Assurance
  
To ensure the consistent quality of the product & to continuously meet the  
customer's requirements, we have stringent Quality Assurance Systems in
place for monitoring and upholding the over all quality system. The control of
the product quality during production is maintained by in-process quality tests
and quality audits. A continuing employee training program, equipment and
process validation and a self-inspection program are part of the company’s
approach to Quality Assurance. Special emphasis is placed on thorough
documentation (SOPs, Master formulae, Specifications, validation protocols
etc.) and review of the entire manufacturing and control process. Our Quality
Assurance systems are supported by our Quality Policy and Quality Manual,
which have been compiled as per cGMP Directives and Guidelines and the
directives of various international regulatory bodies like the USFDA, UKMHRA
and the EC
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