Biopharmax Group www.biopharmax.com

Biopharmax Group
www.biopharmax.com
Introduction
Capabilities
Project examples
Summary
Biopharmax Group
www.biopharmax.com
Overview
A global design and construction provider of manufacturing
plants and systems for Biopharmaceutical companies.
Over 35 years experience exclusively in the Biotechnological,
API and Pharmaceutical Industries.
Over 140 engineers, programmers and technicians with diverse
experience in a niche segment.
In house multidiscipline capabilities for design, delivery and
validation.
Biopharmax Group
www.biopharmax.com
Overview
Biopharmax accumulated know how and turnkey approach
enable control of costs and timelines of the project, single point
of responsibility as well as minimal interference to the client
ongoing operations.
Over 70% of Biopharmax projects are done worldwide (outside
of Israel), FDA / EMEA compliant.
Projects in the pharmaceuticals and biotechnology industries
designed and executed in over 15 countries for the past
decades.
Biopharmax Group
www.biopharmax.com
Mission
Design, Build & Validate
Tailor made
Biotechnology / Pharmaceutical
Manufacturing plants
Biopharmax Group
www.biopharmax.com
Complete Plants
Greenfield
Existing structure
Scale up
Pilot plants
Plant expansion
Filling and formulation
Solutions
Process Lines
Sterile, Aseptic
Production Subsystems
UF, Fermentation
Chromatography
Critical Utilities
WFI/PW, CIP/SIP
Biopharmax Group
www.biopharmax.com
International
presence
Private Holding Company
Biopharmax Ltd. (Israel)
Biopharmax
Inc. (USA)
Biopharmax
Italy
Biopharmax Group
Biopharmax Group Ltd.
Biopharmax
Turkey
www.biopharmax.com
Biopharmax
Canada
Biopharmax
Ireland
Biopharmax B.V (Netherlands)
Biopharmax
India
Biopharmax
Puerto Rico
Biopharmax
China
Worldwide
activities
Netherlands
Italy
Ireland
Canada
CA
NC
NJ
Turkey
Israel
USA
Mexico
Hungary
Romania
India
Puerto Rico
Singapore
Biopharmax Group
www.biopharmax.com
China
Capabilities
Biopharmax Group
www.biopharmax.com
Multidiscipline
engineering
Biopharmax Group
www.biopharmax.com
Engineering Disciplines
Process
Civil
HVAC
Mechanical
Software &
Control
Industrial
Chemical
Electro
Mechanical
Validation
Fields of
expertise
Sterile production & filling
WFI, PW (USP, EU)
CIP/SIP
Clean rooms & laboratories
Software and Hardware
Complete validation
Biopharmax Group
www.biopharmax.com
Advanced
work methods
 Advanced CAD tools with 3D modules to shorten design and maximize
installations compliance
 Scale up and compliance to manufacturing scale, process optimization, yield
enhancement, reduction of cycle time
 Integration of utilities into the plant systems and automation
 In house programming department with specialized know-how according to the
needs of the Biopharmaceuticals industry
 Network of international suppliers with local after sale services and support
Biopharmax Group
www.biopharmax.com
Meet
international
standards
FDA, EMEA, cGMP and CE standards
Global standards and fabrication codes used
21CFR11, GAMP 5, S88 software compliance
ISO 9001:2000 and IQ NET approved
Biopharmax Group
www.biopharmax.com
Added Values
Lump Sum TK approach – based on diverse
engineering abilities, all in house
Cost effective – low labor costs and smart procurement,
while maintaining the highest standards
Fast delivery ability – minimizing time to market for
clients production, enabling competitive edge
Financially strong – references from international banks,
solid track record, consistent growth
Competent & professional management team with
international experience
Biopharmax Group
www.biopharmax.com
Project examples
Biopharmax Group
www.biopharmax.com
Project examples
Johnson & Johnson Omrix
Israel, Jerusalem
Biopharmax Group
www.biopharmax.com
Project examples
Johnson & Johnson Omrix
Israel, Jerusalem
Biopharmax Group
www.biopharmax.com
Project examples
Johnson & Johnson Omrix
Israel, Jerusalem
Biopharmax Group
www.biopharmax.com
Project examples
Johnson & Johnson Omrix
Israel, Jerusalem
Fibrin sealant sterile production plant
Raw material human plasma and cryo
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Biopharmax Group
www.biopharmax.com
Production lines
Process equipment
Clean rooms
Filling suite, packaging department
Clean and general utilities
Warehouses, laboratories, offices
Complete commissioning and validation
EMEA compliant
Project examples
SciGen
India
Biopharmax Group
www.biopharmax.com
Project examples
SciGen
India
Biopharmax Group
www.biopharmax.com
Project examples
SciGen
India
Biotechnology production plant
Insulin crystals and other recombinant products
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Biopharmax Group
www.biopharmax.com
10 acres area with a 9,000 SQM building
Process equipment, fermentors
Upstream, Downstream and final purification
Clean utilities and general utilities
Warehouses, laboratories, offices
Software per CFR21part11
Complete commissioning and validation
EMEA compliant
Project examples
HSBBC
Republic of China
Biopharmax Group
www.biopharmax.com
Project examples
HSBBC
Republic of China
Biotechnology fill finish plant
For Insulin & Hep-B products
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Biopharmax Group
www.biopharmax.com
Final compounding department
Aseptic filling line for vials
Aseptic filling line for cartridges
Aseptic filling line for pre filled syringes
Packaging department
EMEA compliant
Project examples
Johnson & Johnson
Colbar Life Science
Israel
Biopharmax Group
www.biopharmax.com
Project examples
Johnson & Johnson
Colbar Life Science
Israel
Aseptic collagen production plant
For injectable application
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Biopharmax Group
www.biopharmax.com
Water for injection production and storage
CIP systems
UF skids
PC/PLC consolidated control system
Warehouse and packaging department
Complete commissioning and validation
FDA / EMEA compliant
Project examples
Johnson & Johnson
Ethicon
Israel
Biopharmax Group
www.biopharmax.com
Project examples
Johnson & Johnson
Ethicon
Israel
Application of biological glue compound over
fleece matrix for surgeries (aseptic applications)
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Biopharmax Group
www.biopharmax.com
Class 5, class 7 production rooms
Freeze drying suite
Packaging department
Clean utilities
Clean rooms
Laboratories
Project examples
NRC Nuclear
Research Center
Biopharmax Group
www.biopharmax.com
Project examples
NRC Nuclear
Research Center
Aseptic Production and filling plant
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Biopharmax Group
www.biopharmax.com
Automatic aseptic production line
Filling line: washing machine, sterilizing oven, sterile filling
machine, capping machine
Clean rooms 100, 10,000 and 100,000 class and HVAC
Purified water production
Water for injection production and storage
Freeze drying with SIP
Autoclaves
PC/PLC consolidated control system for all the plant machinery
Full commissioning and validation
EMEA compliant
Facility approved by the Netherlands Health Authorities
Project examples
Cure Medical
Israel
Biopharmax Group
www.biopharmax.com
Project examples
Cure Medical
Israel
Production plant for intervenes solutions
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Biopharmax Group
www.biopharmax.com
Filling machine, over wrapping, automatic sterilization
Clean rooms for sterile production
HVAC system to supply the clean rooms
Purified water system
Water for injection
Pure steam system
Autoclave and sterilization line
PC/PLC consolidated control system for all the plant machinery
ERP computerized system
Project examples
Taro Pharmaceuticals
Israel
Biopharmax Group
www.biopharmax.com
Project examples
Taro Pharmaceuticals
Israel
Multi purpose API manufacturing plant
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Biopharmax Group
www.biopharmax.com
Fully automated manufacturing facility
Complete integration of systems
Purified water systems
Production, storage and distribution
PC/PLC consolidated control system for all plant consumers
Full commissioning and validation
FDA compliant
Project examples
Novopharm, Teva
Canada
Biopharmax Group
www.biopharmax.com
Project examples
Novopharm, Teva
Canada
Final formulation manufacturing plant
Stouffville and Hood Road
 Purified water system
 Pretreatment, production, storage and distribution
 PC/PLC consolidated control system for all
system/subsystems
 Full commissioning and validation
 FDA compliant
Biopharmax Group
www.biopharmax.com
Project examples
Merck Serono
Interpharm
Israel
Biopharmax Group
www.biopharmax.com
Project examples
Merck Serono
Interpharm
Israel
R&D Center for Biotechnological products
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Biopharmax Group
www.biopharmax.com
Biotechnology laboratory
R&D laboratory
Chemical laboratories
Offices
Storage
Total area: 3,000 SQM
Project examples
BTG / Ferring
Israel
Biopharmax Group
www.biopharmax.com
Project examples
BTG / Ferring
Israel
Biological recombinant products
Manufacturing plant
 Fully computerized production units
 Clean utilities:
PW, WFI, PS production and distribution system
 CIP - Multi pass, double tanks, flow control, pressure control,
automatic dosing
 Commissioning and validation
 FDA compliant
Biopharmax Group
www.biopharmax.com
Project examples
PBF Probifasa
Mexico
Biopharmax Group
www.biopharmax.com
Project examples
PBF Probifasa
Mexico
Blood products manufacturing plant
Sterile albumin filling
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Biopharmax Group
www.biopharmax.com
Washing machine, sterilizing tunnel, filling machine
Clean rooms for the filling line and processing equipment
HVAC system to supply the clean rooms
WFI production and storage system
PC/PLC consolidated control system
Full commissioning and validation
Project examples
Omrix
Israel, Tel-Hashomer
Biopharmax Group
www.biopharmax.com
Project examples
Omrix
Israel, Tel-Hashomer
Plasma fractionation manufacturing plant
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Biopharmax Group
www.biopharmax.com
100,000 liter per year
IVIG production department
Albumin factor VIII production facility
Biological glue production facility
Filling suites
Packaging department
Clean utilities
Clean rooms
Laboratories
Commissioning and validation
FDA compliant
Project examples
Teva Italy
3 TK Projects
Biopharmax Group
www.biopharmax.com
Project examples
Teva Italy
3 TK Projects
Vilanterio plant
 CAM increasing capacity: design, supply equipment piping
instruments, equipment erection, piping installations, control
works, validation
 Modernization control of the process: design , supply
instruments control works, validation
Settimo plant
 Increasing production capacity: design , supply equipment,
piping instruments, equipment erection, piping installation,
control works, validation
 Clean rooms for finishing department: design and construction
Bulciago plant
 Replacement of 4 Glass lined reactors 15 CuM: dismount used
reactors, erection of new reactors, piping installation,
instrumentation and control
Biopharmax Group
www.biopharmax.com
Project examples
IVAX
Puerto Rico
Biopharmax Group
www.biopharmax.com
Project examples
IVAX
Puerto Rico
API manufacturing plant
Tech –transfer and scale up
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Biopharmax Group
www.biopharmax.com
Equipment design and installation
Controls and programming
Civil structure – design and installation
Clean rooms and HVAC systems – design and installation
Full commissioning
FDA compliant
Project examples
Teva Tech R&D Labs
Israel
Biopharmax Group
www.biopharmax.com
Project examples
Teva Tech R&D Labs
Israel
API R&D center
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Biopharmax Group
www.biopharmax.com
Clean rooms – class 8
Analytical laboratories
Chemical laboratories
Pilot manufacturing unit
HVAC and control
Tailor hoods
Offices
Total area 2200 SQM
Restoration and re-operation
Chemical production line
within 39 days
Project examples
Prosintex
Italy
After explosion
Biopharmax Group
www.biopharmax.com
Project examples
Prosintex
Italy
Restoration and re-operation of chemical production line
within 39 days
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Biopharmax Group
www.biopharmax.com
Decontamination
Civil construction work
Equipment erection and replacement
Piping installation
Control and programming
Full commissioning and validation
FDA compliant
Project examples
SciGen
Israel
Biopharmax Group
www.biopharmax.com
Project examples
SciGen
Israel
Hep-B production and filling plant
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Biopharmax Group
www.biopharmax.com
Bio fermentor production suite
Laboratories
General areas, Offices, packaging rooms
Clean Rooms (ISO 9,8,5)
WFI System
Pure steam system supplies dry saturated USP/EU
clean steam to plant equipment for sterilization in
place
Cryogenic tanks supply pure gasses (N2, O2, CO2)
to the consumers and labs
Full integration of all the control systems – HVAC,
WFI, media, production and utilities per CFR 21 Part
11.
Full validation and documentation
EMEA compliant
Satisfied costumers around the globe
Netherland
Italy
Ireland
Canada
CA
NC
USA
Hungary
Turkey
China
Israel
NJ
India
Mexico
Puerto Rico
Singapore
Biopharmax Group
www.biopharmax.com
Summary
On Time!
On Budget!
No compromises on results!
Biopharmax Group
www.biopharmax.com
Thank you for your time
Biopharmax Group
www.biopharmax.com
Projects Listings
Custom made production systems / facilities
Company
Project Description
Project Type
Industry
Scigen
Insulin crystals and other products production, 10-acres area,
9,000 sqm building. Process equipment, fermentors, Upstream
department, Downstream department and final purification.
Turnkey
Biotechnology
HSBBC
Biopharmaceutical fill finish plant including aseptic filling lines,
Vial cartridge pre filled syringes, and packaging lines.
Turnkey
Biopharmaceutical
Colbar
Johnson & Johnson
Process design and realization for syringes production
upgrade.
Turnkey
Biopharmaceutical
More Energy
Solvent preparation – Electrical battery production facility
Turnkey
Electrical Batteries
Scigen
New complete vaccine production plant including bioreactors,
Downstream production and fill finish.
Turnkey
Biopharmaceutical
Ethicon
Johnson & Johnson
Biological glue compound over fleece matrix. Clean rooms
class 5/7, laboratories, production rooms, freeze drying suite,
packaging room, clean utilities, WFI
Turnkey
Compugen
R&D production facility: laboratories, WFI, Clean O2 system
with automatic replacing, Oil free air with backup system, CO2
with automatic replacing, hot rooms, cold rooms, offices.
Turnkey
Nuclear Research Center
(NRC)
Automatic aseptic production system, Aseptic filling line, Clean
rooms and HVAC ,PW,WFI
Turnkey
Biopharmax Group
www.biopharmax.com
Biopharmaceutical
Biotechnology
Radio Pharmaceutical
(Biotechnology)
Projects Listings
Custom made production systems / facilities
Company
Project Description
Project Type
Industry
Colbar
Aseptic Collagen production plant WFI, CIP
Turnkey
Pharmaceutical
Spuntec
New Production Plant
Design-Build
Non Woven Fabric
Inotek
Complete plant
Turnkey
Fine Chemicals (API)
AFG
Liquid Production System
Turnkey
Cosmetics
Bio Technology
General Corp (BTG)
Ultra-Filtration (45 m3/hr) skid
Turnkey
Biotechnology
Biological Research Institute
Biological Fermentors
Design &
Software
R&D
Biotechnology
Omrix
Sterile production system for biological adhesive
Design
Biopharmaceutical
PBF Technologies
Sterile production system for Human Albumin
Turnkey
Biopharmaceutical
Cure Medical
Plant for production of LVP IV
Turnkey
Infusion
Interpharm Serono
Media and Buffer production systems
Design &
Software
Pharmaceutical
Biopharmax Group
www.biopharmax.com
Projects Listings
Purified water / Water for injection projects
Company
System Type
Project Type
Industry
Ethicon
Johnson & Johnson
Pretreatment multi media, softeners, carbon filter – 1 m3/hr
Distillation unit – 60 lit/hr
PW Storage Tank – 1 m3
Hot WFI distribution loop – POU cooling
Turnkey
Biopharmaceutical
Teva Biogenerics
Pretreatment multi media, softeners, carbon filter – 2 m3/hr
Distillation unit – 0.35 m3/hr
PW Storage Tank – 1.5 m3
Heat sanitized loop with ambient circulation
Turnkey
Biopharmaceutical
Inotek
Pretreatment multi media and softeners – 3 m3/hr
Single Pass Hot Water Sanitizable RO – 0.32 m3/hr
Single Unit Hot Water Sanitizable CDI LX – 0.32 m3/hr
PW Storage Tank – 1.1 m3
Heat sanitized loop with ambient circulation
Turnkey
Pharmaceutical
Compugen
Pretreatment multi media and softeners – 1.2 m3/hr
Distillation unit – 100 lit/hr
WFI Storage Tank – 1 m3
Heat sanitized loop with ambient circulation
Turnkey
Biopharmaceutical
Novopharm (Stouffville)
PW Pretreatment multi media and softeners
Turnkey
Pharmaceutical
Biopharmax Group
www.biopharmax.com
Projects Listings
Projects Listings
Purified water / Water for injection projects
Company
System Type
Project Type
Industry
Novopharm
(Hood Road)
PW Pretreatment multi media and softeners
Turnkey
Pharmaceutical
Teva
(Har Hotzvim)
PW Pretreatment multi media and softeners
Design
Pharmaceutical
Colbar
Pretreatment multi media and softeners. Compression
Distillation Unit .Hot WFI distribution loop – POU cooling
Turnkey
Pharmaceutical
Biological Research Institute
PW Storage and Distribution
Design
R&D
Nuclear Research
Center (NRC)
WFI Pretreatment multi media and softeners .
Compression Distillation Unit. WFI Storage.
Turnkey
Pharmaceutical
Omrix
Ambient RO Distribution Loop – 2000 I/Hour
Turnkey
Pharmaceutical
Omrix
Hot WFI distribution loop – 7000 I/hour
Turnkey
Biopharmaceutical
Teva (ICI)
Pretreatment multi media & softeners
Turnkey
Fine Chemicals (API)
Biopharmax Group
www.biopharmax.com
Projects Listings
Clean in place / Sterilization in place projects
Company
System Type
Project Type
Industry
Biotechnology General Corp
(BTG)
CIP- Once Through, single tanks, flow control, pressure
control, automatic dosing
Turnkey
Biotechnology
Biotechnology General Corp
(BTG)
CIP - Multi pass, double tanks, flow control, pressure control,
automatic dosing
Turnkey
Biotechnology
Biological Research Institute
CIP skid
Turnkey
R&D
Omrix
CIP - Multi pass, double tanks, flow control, pressure control,
automatic dosing
Turnkey
Pharmaceutical
Omrix
SIP station
Turnkey
Pharmaceutical
Cure Medical
SIP- IV infusion plant
Turnkey
Infusion
Interpharm Serono
CIP/SIP for media and buffer production systems
Design
Pharmaceutical
Biopharmax Group
www.biopharmax.com
Projects Listings
Clean rooms projects ISO 14644-1
Company
Clean Room Class
Area (sqm)
Project type
Ethicon – Johnson & Johnson
ISO 5,7
300
Turnkey
Biogal- Teva Hungary
ISO 9
320
Turnkey
NRC – Nuclear Research
Center (Radio Pharmaceuticals)
ISO 5,6,7,8,9
400
Turnkey
Inotek – API pilot plant
ISO 8,9
800
Turnkey
Teva Tech, Plant 20
ISO 8,9
200
Turnkey
Vision Care
ISO 4,5,7
200
Turnkey
Given Imaging
ISO 4,5,6
300
Turnkey
Given Imaging
ISO 4,5,6
300
Turnkey
Teva Tech, Plant 20- Centrifuge
Rooms
ISO 9
150
Turnkey
Biopharmax Group
www.biopharmax.com
Projects Listings
Clean rooms projects ISO 14644-1
Company
Clean Room Class
Area (sqm)
Project type
Teva (ICI) – Centrifuge
Rooms
ISO 9
80
Turnkey
Teva (ICI)
ISO 9
100
Turnkey
Taro- Plant 16,17
ISO 8,9
650
Turnkey
Pamol Luxemburg
ISO 8
115
Turnkey
Agis – Hormon
ISO 7,8
170
Turnkey
Given Imaging
ISO 5,6
150
Turnkey
Bluebird
ISO 6,7
350
Turnkey
Teva Tech, Plant 16Peptides
ISO 9
150
Turnkey
Teva Tech, Plant 19- Cop 1
ISO 7,8,9
700
Turnkey
Biopharmax Group
www.biopharmax.com
Projects Listings
Clean rooms projects ISO 14644-1
Company
Clean Room Class
Area (Sqm)
Project type
Taro Pharmaceutical
Plant
ISO 8,9
500
Turnkey
Teva Tech, Plant 12Centrifuge Rooms
ISO 9
600
Turnkey
Chemagis – Mini
Pilot
ISO 8
70
Turnkey
PBF Biotechnologies
ISO 8
200
Turnkey
Biopharmax Group
www.biopharmax.com
Projects Listings
Laboratory projects
Client
Area
Lab Type
Execution
Inotek
150 m2
Analytical and pilot
Turn Key
Teva Tech
1600 m2
R&D and Analaytical
Turn Key
Teva Assia 1
600 m2
Chemical
Turn Key
Teva Assia 2
200 m2
Chemical
Turn Key
Teva
(Ramat Hovav)
300 m2
Q.C.
Turn Key
Teva
(Ramat Hovav)
100 m2
Peptide
Turn Key
Pharma TwoB
300 m2
Biological
Turn Key
Biopharmax Group
www.biopharmax.com
Projects Listings
Biopharmax Group
Laboratory projects
Client
Area
Lab Type
Execution
Agis
250 m2
Mini plant
Turn Key
Omrix
650 m2
Biological
Turn Key
Chromtec
600 m2
Chemical
Turn Key
Proneuron
700 m2
Biological
Design
Compugen
(Rehovot)
200 m2
Biological
Turn Key
Compugen
(Ashkelon)
500 m2
Chemical
Turn Key
Cure Medical
400 m2
Biological
Turn Key
www.biopharmax.com