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ON

Plot No. 2-D1, Obadenahalli, 3rd

Phase KIADB Industrial Area,

Doddaballapur taluk, Bangalore Rural District – 561 205, Karnataka State.

Table of Contents

1. EXECUTIVE SUMMARY

2. INTRODUCTION OF THE PROJECT/ BACKGROUND INFORMATION

3. PROJECT DESCRIPTION

4. SITE ANALYSIS

5. PLANNING

6. PROPOSED INFRASTRUCTURE

7. REHABILITATION AND RESETTLEMENT (R&R) PLAN

8. PROJECT SCHEDULE & COST ESTIMATION

9. ANALYSIS OF PROPOSAL (FINAL RECOMMENDATION)

1. Executive Summary

M/s STELIS Biopharma Pvt. Ltd., is setting up a new biopharmaceutical facility to manufacture

Monoclonal Antibodies and Therapeutic Proteins.

This industry is promoted by director Shri Joe Thomas.

The plant is proposed to construct in about 10 acres of land.

Products to be manufactured are

1. Monoclonal Antibodies

2. Therapeutic Proteins.

The Company requires 3500 KVA power for the proposed project. The company also proposes

to install 3 no’s of DG sets for standby arrangement during emergency only.

The source of water is from KIADB. The unit requires about 150 KLD during the operational

phase.

Zero discharge effluent treatment plant along with kill system is provided. The Company

proposes to have an Effluent Treatment Plant (ETP) within the premises.

The plant locational advantages regarding the infrastructural facilities like power, water, and

roads are fully developed and connected to National Highways.

The total estimated cost of the project is Rs. 248.00 Crores.

4

2. Introduction of the Project/ Background Information

2.1 Identification of project and project proponent

M/s STELIS Biopharma Pvt. Ltd., is located at Plot No. 2-D1, Obadenahalli, 3rd

Phase

KIADB Industrial Area, Doddaballapur taluk, Bangalore Rural District – 561 205,

Karnataka State. M/s STELIS Biopharma Pvt. Ltd. is proposing to construct biopharmaceutical

facilities to manufacture Monoclonal Antibodies and Therapeutic Proteins.

2.2 Promoters

The affairs of the company are being managed by the director Shri Joe Thomas.

Joe Thomas

Joe has worked with Strides for over 6 years and has over 28 years’ experience in Business

Development, Strategy formulation and Global Marketing Prior to joining Strides, has held many

significant positions in The STC of India, Procter & Gamble Asia Pacific and Bio Serve

Biotechnologies. He brings broad and in-depth domain knowledge in Life Sciences (Pharma

Biotech and OTC Health) and Strategic and General Management expertise. He has held senior

leadership level positions as Regional Director for P&G’s Asia Export Operations in Singapore

and MD/COO Global in Bio Serve India/US. Joe also serves on several Management &

Advisory Boards of start-up firms to help guide their growth strategies.

He is a Post Graduate in Chemistry with a diploma in Foreign Trade. At Strides, Joe leads

initiatives for identifying future value streams and building the capability and capacity to execute

strategic business initiatives.

He is a member of the Global Leadership Council (GLC) of the Company.

2.3 Brief description and nature of the project.

The proposed project will be manufacturing Monoclonal Antibodies and Therapeutic Proteins.

The installed capacity is 18.2 kg per month. The proposed project aims to meet the local &

global demand for contract manufacturing. The facility is intended to produce bio-chemicals and

therapeutic proteins on a campaign basis and is designed to meet both USFDA and EU

regulations in addition to the regional requirements of schedule M as per Indian Standards. The

process of manufacturing bio-chemicals and therapeutic proteins are produced from raw

materials like Sodium chloride, Potassium chloride, Sodium phosphate and Potassium phosphate

etc. The industry will mainly concentrate on zero discharge of effluents.

2.4 Need for the project and its importance to the country and/or region.

Products that are of Monoclonal Antibodies and Therapeutic Proteins will be utilized &

manufactured based on the requirement of domestic & export markets.

5

2.5 Export possibility

Products manufactured from this facility will be exported to cater to the requirements of

international market.

2.6 Employment Generation

Man power required for the construction of project building will be employed from nearby

places. Directly around 125 numbers of qualified, skilled and semi-skilled man power will be

recruited both on temporary and permanent basis from nearby places. Thus, the industry provides

an employment opportunity for local people.

6

3. Project Description

3.1. Type of project including interlinked and interdependent project, if any.

Not applicable

3.2. Location with coordinates.

Figure: Areal view of the proposed project site

3.3. Details of alternative sites, considered and the basis of selecting the proposed site

particularly the environmental considerations gone into should be highlighted.

Not applicable

3.4. Size & magnitude of operation

The proposed project envisages the production of following Products:

1. Monoclonal Antibodies

2. Therapeutic proteins

Total quantity: 18.2 kg per month

3.5. Project process details (a schematic diagram/flow chart showing the project layout, components of the project etc.) should be

given.

Process Flow Diagram : Drug- Substance

Raw Material Inputs Waste Output

Bioreactor -2000L

Centrifuge

W. Water: 1600 L

Step 1

Fermentation

Media - 32Kg

Glucose- 6400g

Sodium bicarbonate -3200g

Pluronic F68 -1600g

L-Glutamine - 480g

Water- 3600L

Seed Development

(10L – 50L - 200L-500L)

Cell Culture broth – 2000 L.

Protein – 3000gms

Step 2

Centrifugation

NaCl: 4000g

KCl: 100g

Na2HPO4:722g

KH2PO4: 120g

Water: 4000 L

NaCl: 800g

KCl: 20g

Na2HPO4: 144g

KH2PO4: 24g

Water: 3600 L

Cell Debris: 40 Kg

Protein: 2910g

NaCl: 3200g

KCl: 80g

Na2HPO4: 578g

KH2PO4: 96g

Water: 2400L

Working Cell Bank (Vial -l ml)

Media – 8kgs

Water - 400L Waste NIL

Media: Serum free media for

growing mammalian cells

(composition proprietary to the

manufacturer)

8

Lenticular Filtration + 0.2µm sterile

filtration

Purification - Affinity Chromatography

W.Water: 2000 L Step 3

Harvest

NaCl: 800g

KCl: 20g

Na2HPO4:144g

KH2PO4: 24g

Water: 2000 L

Protein: 2851.8g

NaCl: 4000g

KCl: 100g

Na2HPO4:722g

KH2PO4: 120g

Water: 2400 L

Step 4

Purification

NaCl: 112810g

Na2HPO4: 1966g

NaH2PO4: 1074g

Citric acid: 9093g

Sodium Citrate: 20794g

NaOH: 5148g

Ethanol: 44.9Kg

Water: 12000 L

NaCl: 116810g

Na2HPO4: 1796g

NaH2PO4: 1966g

Citric acid: 1714g


NaOH: 5148g

Ethanol: 44.9Kg

KCl: 100g

KH2PO4: 120g

Water: 13216 L

Protein: 142.8 g

Protein: 2709 g

Citric acid: 7379g


Water: 1184 L

Virus Inactivation W.Water : 1950 L Phosphoric Acid: 985.73g

Tris Base: 1137g

Water: 2000 L

Protein: 2709g

Citric acid: 7379g


Phosphoric Acid: 985.73g

Tris Base: 1137 g

Water: 1234 L

9

Lenticular Filtration

NaCl: 432g

Na2HPO4: 78g

KCl: 10.8g

KH2PO4: 13g

Water: 2000 L

Protein: 2709 g

Citric acid: 7379g



Tris Base: 1137g

NaCl: 432g

Na2HPO4: 78g

KCl: 10.8g

KH2PO4: 13g

Water: 1284 L

W.Water: 1950 L

Virus Inactivation


W.Water: 1950 L

Step 5

Virus Inactivation


Tris Base: 1137g

Water:2000 L

Protein: 2709g

Citric acid: 7379g



Tris Base: 2274 gm

Water: 1334 L

Nacl: 432g

Na2HPO4: 78g

Kcl: 10.8g

KH2PO4: 13g

Step 6


NaCl: 432g

Na2HPO4:78g

KCl: 10.8g

KH2PO4: 13g

Water: 2000 L

W.Water: 1950 L

10

Concentration & Diafiltration

Purification - 2

Anion Exchange Chromatography

Step 7

Concentration &

Diafiltration

HCl: 2906.59g

Tris Base: 8645g

Water: 5000 L

Protein: 2522g

HCl: 581.72g

Tris Base: 1730g

Water: 250 L

Step 8

Purification- 2

Tris Base: 22988g

HCl: 7729.2g

NaCl: 72219g

NaOH: 19000g

Ethanol: 49.77Kg

Water: 8000 L

Tris Base: 21270g

HCl: 7151.54g

NaCl: 55575g

NaOH: 19000g

Ethanol: 49.77Kg

Water: 7680 L

Citric acid: 7379g

Sodium Citrate: 2230 g


Tris Base: 8182g

HCl: 2324.86g

NaCl: 432g

Na2HPO4: 278g

KCl: 10.8g

KH2PO4: 13g

Water: 6134 L

Protein: 2471g

Tris Base: 3448g

HCl: 1159.38g

NaCl: 16644g

Water: 570L

Protein: 2655g

Citric acid: 7379g

Sodium Citrate: 2230 g


Tris Base: 1137g

NaCl: 432g

Na2HPO4: 278g

KCl: 10.8g

KH2PO4: 13g

Water: 1384 L

11

Viral Filtration

Purification - 3

Cation Exchange Chromatography

Step 9

Viral Filtration

HCl: 61.02g

Tris Base: 181g

Water: 1000 L

Protein: 2347g

HCl: 1362.78g

Tris Base: 3629g

NaCl: 16644g

Water: 600L

Step 10

Purification- 3

Sodium Acetate: 10293g

Acetic acid: 651.43g

Tris Base: 8052g

NaCl: 79192g

NaOH: 10860g

Ethanol: 47.1Kg

Water: 10000 L



HCl: 1464.48g

Tris Base: 3629g

NaCl: 69469g

NaOH: 10860g

Ethanol: 47.1Kg

Water: 9697 L Protein: 2300g



NaCl: 26367g

Water: 903L

W.Water: 970 L

Concentration Step 11

Concentration Water: 4000 L

Protein: 2277g


Acetic acid: 35.67g

Nacl: 4321g

Water: 200 L



Nacl: 22046g

Water: 4703 L

12

Formulation & Filling facility

Water consumption, KL

Per batch , kl No. of batches Per Month No. of days Per Day

Drug substance facility 58 8 464 25 18.56

Formulation and filling 21.25 15 318.75 25 12.75

Waste water generation, KL

Per batch , kl No. of batches Per Month No. of days Per Day

Drug substance facility 57.972 8 463.776 25 18.551

Formulation and filling 21.25 15 318.75 25 12.75

Step 12

Formulation and

Filling


Acetic acid: 94.41g

Sorbitol: 10 Kg

Water: 21250 L

Formulation and Filling into vials/

Cartridges/ Prefilled Syringes

W.Water: 21250 L

3.6. Raw material required along with estimated quantity, likely source, marketing area

of final products, mode of transport of raw material and finished products.

Raw materials required, for the production of Monoclonal Antibodies and Therapeutic Proteins

are Sodium chloride, Potassium Chloride, Sodium phosphate, Potassium phosphate, Citric acid,

Sodium Citrate, Tris Base, Sodium Acetate, Sodium Hydroxide, Glucose and Sodium

bicarbonate etc., are procured from the local markets.

A. Raw Materials Availability and Source of Market

Raw material availability and source of marketing will be from local market.

B. Raw Materials Requirement

S. No. Raw Materials Details Quantity per Annum, Kgs.

1 Sodium chloride 3358

2 Potassium Chloride 3

3 Sodium phosphate 80

4 Potassium phosphate 3

5 Citric acid 182

6 Sodium Citrate 416

7 Tris Base 659

8 Sodium Acetate 210

9 Sodium Hydroxide 700

10 Glucose 160

11 Sodium bicarbonate 80

12 Pluronic F68 40

13 Protien Free Media 640

14 L-Glutamine 12

15 Sorbitol 200

16 Ethanol 1200

17 Phosphoric Acid 12

18 Acetic Acid 14

19 Hydrochloric acid 210

3.7. Resource optimization/recycling and reuse envisaged in the project, if any, should be

briefly outlined.

The resource that are recycled and reused are shown in the above process details i.e., in material

balance.

14

3.8. Availability of water its source, Energy/power requirement and sources should be

given.

Water Requirement

The main source of water is from Karnataka Water Board,. The unit requires about 150 KLD for

its manufacturing and other activities.

Power Requirement

The Company requires 3500 KVA Electrical power and HSD is used in DG set. The company

also proposes to install 3 no’s DG sets of capacity 1500 KVA which is utilized during emergency

only.

3.9 Quantity of wastes to be generated (liquid and solid) and scheme for their

Management/disposal.

Quantity of water requirement and waste water generated from the proposed project activity is

listed below

ETP will be designed for 60 KLD. Total solid waste generated from the ETP as sludge will be

reused as manure for greenbelt development.

3.10. Schematic representations of the feasibility drawing which give information of EIA

purpose

Not Applicable

Activity Water requirement

KLD

Wastewater Quantity in

KLD

Process Water 31.3 32.0

Washings 10.0 4.5

Boiler/ Cooling tower 79.5 6.9

Domestic 10.0 9.0

RO Reject 15.0 --

Total 145.8 52.4

15

4. Site Analysis

4.1. Connectivity

The project site is located at Plot no: 2-D1, 3rd

Phase Industrial area, Obadenahalli,

Doddaballapur taluk, Bangalore rural district. It is 3.92 Km away from Doddaballapur towards

NW direction. The excess road of the site is connected to Nagadenahalli road which is connected

to NH- 207 in North direction and nearest highway is National Highway-207 at a distance of

1.06 Km towards North direction. Doddaballapur Railway Station is 3.09 Km towards West

direction from the proposed project site. Obadenahalli is at a distance of 0.21 Km towards SW

direction from the project site. Hence, no new routes or alterations are required in this regard.

4.2. Land form, land use and land ownership

The proposed project is located in Obadenahalli village nearer to Doddaballapur taluk. M/s

STELIS Biopharma Pvt. Ltd. has purchased the industrial area plot from KIADB.

4.3. Topography (along with map)

The Doddaballapur taluk is bounded by Tumakuru district on NW direction, Bangalore district

on South direction, Chikkaballapura district is at NE direction and Kolar district on SE direction.

The Doddaballapur lies at a distance of 27.6 kms from the Bangalore rural district. The ground is

mostly of rocky upland, plateau and flat- topped hills at an elevation of about 900m above MSL.

16

Figure: Location of the proposed project site with 10Km radius demarcation on topo sheet

4.4. Existing land use pattern (agriculture, non-agriculture, forest, water bodies (including

area under CRZ), shortest distances from the periphery of the project to periphery of the

forest, national parks, wild life sanctuary, eco sensitive areas, water bodies (distance from, the

HFL of the river)). In case of notified industrial area a copy of the Gazette notification should

be given.

Salient features Distance in Km

Obadenahalli 0.21 (SW)

Doddaballapur Railway Station 3.09 (W)

National Highway- 207 1.06 (N)

17

4.5. Existing Infrastructure

The proposed project is well connected by road. The approach road to the project site is National

Highway- 207. Water supply to the proposed project is from KIADB, in house bore well, outside

purchase. Electrical demand is from KPTCL and DG set will be used during the power cuts &

plant requirements. M/s STELIS Biopharma Pvt. Ltd. has a land comprising of following blocks:

1. Production block - Drug Product Formulation (DP block).

2. Ware house.

3. Utility.

4. Reception & lobby.

5. Canteen.

6. Security & Gate office.

7. Others- ETP, Tank farm area, Electrical substation & Fuel storage etc.

4.6. Climatic data from secondary sources

The climate in Doddaballapur district has max temperature is 33.50C and min. temperature is

150C. The Doddaballapur district receives lowest rainfall is 754 mm.

4.7. Social Infrastructure available

The approach road to the project site is NH- 207 which is in the North direction. KPTCL will

provide electricity to the industrial area & water requirement in the area is utilized from KIADB,

in house bore well & outside purchase. Government Hospital, Police Station, Fire Station,

Schools and Colleges are available at Doddaballapur which is located at 3.92 Km towards NW

direction from the proposed project site.

18

5. Planning

5.1. Planning concept (type of industries, facilities, transportation, etc.,) Town and

Country Planning Development authority classification.

The proposed project is M/s STELIS Biopharma Pvt. Ltd. manufacturing industry. Qualified and

Skilled man power is available in and around Doddaballapur & Bangalore both on permanent

and temporary basis. The company is planning to have good team of employees in all areas.

Looking in to long term planning, company will take all the necessary steps to develop a good

team of work force. The company will provide basic amenities to staff & employees.

The company will organize training classes for all the staff in the areas of Process up gradation,

Quality Control, cost reduction techniques, Environment & Safety aspects etc.

5.2. Population Projection:

Around 125 numbers of Qualified, Skilled and Semi-Skilled persons are employed in the

operation of proposed project. Hence, the population inflation in the area is negligible.

5.3. Land use planning

No. Type of Land Use Land Area in

Sq. mtrs

1 Actual Plinth Coverage (DP &

DS Block, Utilities, etc.) 12773.11

2 Actual Landscape 18849.29

3 Parking Area 1766.00

4 Internal Road 6294.00

5 Internal Pathways 790.60

Total Area 40473.00

5.4. Assessment of infrastructure Demand (Physical & Social).

There will not be any negative effect on the living conditions of people. Due to project activities,

the surrounding areas are expected to improve by way of socio-economic development due to

direct and indirect employment and the project will also lead to supporting utilities by improving

job & business opportunities in the locality.

19

5.5. Amenities/facilities

The company will provide all basic amenities to staff & employees such as Medical Health,

Children education, transport, canteen facility, clothing, family welfare etc. as per policy of the

company.

20

6. Proposed Infrastructure

6.1. Industrial Area (Processing area)

No. Type of Land Use Land Area in Sq.

mtrs.

1 DS Block (Ware House) 3500.00

2 DP Block 4442.70

3 Utility Block 835.11

4 Reception & Lobby 445.00

5 Canteen 881.70

6 Security & Gate Office 172.80

7 Others (ETP, Tank farm area,

Electrical substation & Fuel storage) 2495.80

8 Actual Landscape 18849.29

9 Parking Area 1766.00

10 Internal Road 6294.00

11 Internal Pathways 790.60

Total Area 40473.00

6.2. Residential Area (non-processing area)

No housing is provided with in the proposed project site.

6.3. Green Belt

Green belt with selected perennial plant species like Mango, Sapota, Custered, Coconut, Neem

tree, Lawn etc., are grown in and around the site.

6.4. Social Infrastructure

The proposed project is a located in KIADB industrial area, Obadenahalli village, Doddaballapur

taluk having good infrastructure facility.

6.5. Connectivity Traffic and Transportation Road/Rail/Metro/Water ways etc.

The project site is located in Obadenahalli Village, Doddaballapur taluk, Bangalore. It is 3.92

Km away from Doddaballapur. The approach road to the proposed site is Obadenahalli road at a

21

distance of 0.21 Km towards SW direction and National Highway- 207 is at 1.06 Km in North

direction. Doddaballapur Railway Station is 3.09 Km towards West direction from the proposed

project site. Obadenahalli is well connected to the major destinations by road. Hence, no new

routes or alterations are required in this regard.

6.6. Drinking Water management (Source & Supply of water)

The source of water is from Karnataka Water Board. 10 KLD of water will be utilized for

domestic purpose.

6.7. Sewerage System

About 9 KLD of waste water is generated from domestic purpose which is sent to the septic tank

to soak pit.

6.8. Industrial waste management

The industry shall adopt and follow an environmental management plan for abatement of

pollution and overall enhancement of the quality of environment in and around the unit. It is

mainly concentrating for zero discharge of effluents is concerned.

Treated effluent will be reused for green belt development and ETP sludge will be utilized as

manure for green belt development.

6.9. Solid waste management

Solid waste shall collected & stored in HDPE drums and disposed to TSDF facility.

6.10. Power requirement & Supply/Source

The company requires 3500 KVA power for the proposed project and it will be arranged by

KPTCL. The company is also proposing to install 3 no’s of DG sets with 1500 KVA capacity as

standby which is utilized during emergency only.

22

7. Rehabilitation and Resettlement (R&R) Plan

7.1. Policy to be adopted (Central/State) in respect of the project affected persons

including home oustees, land oustees, and landless labourers (a brief outline to be given).

Not applicable, since M/s STELIS Biopharma Pvt. Ltd. has purchased the property in KIADB

industrial area from KIADB for manufacturing Monoclonal Antibodies and Therapeutic

Proteins.

23

8. Project Schedule & Cost Estimation

8.1. Project Schedule

The company is planning to procure ancillary machinery and have its trial production in June,

2017. The commercial production is planned to start from Aug 2017.

8.2. Cost Estimates

The estimated cost of the project is Rs. 248 Crores. Investment breakups of the proposed project

are tabulated below:

Description Amount ( In Rs. in Lakhs )

Land & Building 680

Plant and Machinery 1550

Working capital margin & Contingencies 160

Capital Investment 2480

24

9. Analysis of proposal (Final recommendation)

9.1. Financial and social benefits with special emphasis on the benefit to the local people

including tribal population, if any, in the area.

Qualified and skilled man power is available in nearby places, both on temporary and permanent

basis.

The company is planning to have good team of employees in all areas. Looking in to long term

planning, company will take all the necessary steps to develop a good team of work force. The

company will provide all basic amenities to staff & employees such as Medical Health, Children

education, transport, canteen facility, clothing, family welfare etc. as per policy of the company.

The company will organize training classes for all the staff in the areas of process up gradation,

quality control, cost reduction techniques, environmental safety, etc.

Documents

ON€¦ · Advisory Boards of start-up firms to help guide their growth strategies. ... Fermentation Media ... Formulation and filling 21.25 15 318.75 25 12.75