Proven worldwide parenteral experience -...

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Our comfort zone is here: Whatever your injectable product needs. Wherever you need to be.

Transcript of Proven worldwide parenteral experience -...

Page 1: Proven worldwide parenteral experience - beta.rodpub.combeta.rodpub.com/uploads/112760w_bkp_1004_One2OneBrochure.pdf · Kit Packaging • Global method and process development ...

Our comfort zone is here:

Whatever your injectable product needs. Wherever you need to be.

Find out how One 2 One® can help create your parenteral success.

Call +1-224-212-2267 or +44 (0) 1926 835 554, visit one2onecmo.com, or e-mail [email protected]

Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P10-2631-Apr., 10

Proven worldwide parenteral experience

Welcome to a world of parenteral expertise.

With One 2 One®, you can confidently raise your fill-finish comfort level.

By centralizing global management, One 2 One® seamlessly orchestrates

nine worldwide manufacturing facilities and comprehensive commercialization

services, including regulatory expertise in over 70 local markets. Whether a small

molecule or advanced biologic, from Phase ll through the life of your brand,

One 2 One® is your comfort zone for parenteral contract manufacturing.

Let our proud history and accomplishments be your comfort zone.

One 2 One®, a service of Hospira, was created from the global hospital products business of Abbott Laboratories and has successfully launched hundreds of parenteral products. Extraordinary quality, capacity and security of supply is ensured.

• 80+ years of manufacturing biologics and small molecules

• Practical knowledge of 70+ markets for global regulatory submissions

• A seamlessly coordinated, centralized system for global decision-making and commercialization strategies, infused with local expertise

• Experience with more than 25 different large molecules, 25 dispersed system formulations, 11 cytotoxic products and beta-lactams

• Facilities inspected by FDA, EMEA, MHRA, TGA and numerous other worldwide regulatory agencies

Facility Fill/Finish APIProduct

DevelopmentLyophilization/

Powder FillBiologics Cytotoxics

Emulsions/ Liposomes

Beta-Lactams

Adelaide, Australia l l l

Austin, Texas, USA l

Boulder, Colorado, USA l l

Clayton, North Carolina, USA l l l

Lake Forest, Illinois, USA l

Liscate, Italy l l L/P l

McPherson, Kansas, USA l l L l

Melbourne, Australia l l L l l l

Rocky Mount, North Carolina, USA l

Chennai, India l l L/P l

| Your Parenteral Comfort Zone

Page 2: Proven worldwide parenteral experience - beta.rodpub.combeta.rodpub.com/uploads/112760w_bkp_1004_One2OneBrochure.pdf · Kit Packaging • Global method and process development ...

Onco-Tain™ Vial

Start early to establish your custom comfort zone.

Comprehensive custom commercialization services Expansive global manufacturing capabilities

Rely on our success in biologic, cytotoxic and emulsion products.

One 2 One® has manufactured over 25 different large molecules for leading BioPharma clients, 15 of which are commercial products. Our innovative R&D scientists develop analytical and manufacturing methods to match unique needs for every type of product.

Innovative drug delivery & packaging options

Address every injectable product need, wherever you need it.

By centralizing global management, One 2 One® can thoroughly integrate nine state-of-the-art facilities around the world. It enables our clients to seamlessly deploy the manufacturing scale and capacity to accommodate large and small batch sizes, the world over.

The right solution for your product delivers a competitive edge.

One 2 One® provides a wide variety of delivery options, from vials, bottles, ampuls and prefilled syringes, to proprietary products such as iSecure™ and the ADD-Vantage™ System. It’s about developing simple solutions to streamline workflow, improve accuracy and decrease waste and costs. Have One 2 One® meet your unique product needs for a distinct advantage in the marketplace.

Successful commercialization starts 2-4 years prior to launch, right after proof-of-concept, as you move through Phase II trials. One 2 One® continually partners to guide your product from site selection and technology transfer to cold-chain management and distribution: Syringes

iSecure™ Syringe Prefilled, ready-to-use syringe is a new standard delivering efficiency and simplicity to ensure accuracy and lower costs

Ansyr™ Syringe Prefilled emergency medications in polypropylene plastic syringe with needle-free, luer-lock tip can connect to any valve

Glass Prefilled Syringes with Needle Guards

Cartridges for Pen Devices

Infusion Delivery

VisIV™ Container Premix VisIV™ containers are first to require no overwrap for 40-60% less waste (100% free of PVC and DEHP)

ADD-Vantage™ System Keeps drug and diluent separate until the system is activated so medications can be prepared quickly without needles, syringes or alcohol swabs

Flexible Containers

Packaging

Onco-Tain™ Vial Contains cytotoxic material by providing shatter resistance with a PVC bottom, surface protection with a shrink- wrapped sleeve and clarity of glass for easy inspection

Reconstitution Diluents

Kit Packaging

• Global method and process development

• Fill-finish manufacturing in the U.S., Italy, Australia and India

• Expert regulatory filing strategies for the Americas, Europe, Asia Pacific and ROW

• Custom kits and multilingual labeling and packaging

• Full product release (including QP) and stability testing

• Cold-chain management and shipping validation

Biotechnology 20+ years of biotech product experience

Analytical Full suite of analytical capabilities for wide variety of molecules

Formulation and Pharmaceutical Services Pilot and commercial scale disposable technology

Manufacturing Development and Optimization Fully functional GLP pilot plant facilities

Microbiological Services Sterilization cycle development and validation

Complete range of services from method

development and validation to impurity

identification with ImpurID™

Fulfills every product need specializing in biologics, lyophilization, cytotoxics, sterile compounding and emulsions

Product Development

Manufacturing Capabilities

iSecure™ Syringe

Your Parenteral Comfort Zone

VisIV™ Container

Page 3: Proven worldwide parenteral experience - beta.rodpub.combeta.rodpub.com/uploads/112760w_bkp_1004_One2OneBrochure.pdf · Kit Packaging • Global method and process development ...

Onco-Tain™ Vial

Start early to establish your custom comfort zone.

Comprehensive custom commercialization services Expansive global manufacturing capabilities

Rely on our success in biologic, cytotoxic and emulsion products.

One 2 One® has manufactured over 25 different large molecules for leading BioPharma clients, 15 of which are commercial products. Our innovative R&D scientists develop analytical and manufacturing methods to match unique needs for every type of product.

Innovative drug delivery & packaging options

Address every injectable product need, wherever you need it.

By centralizing global management, One 2 One® can thoroughly integrate nine state-of-the-art facilities around the world. It enables our clients to seamlessly deploy the manufacturing scale and capacity to accommodate large and small batch sizes, the world over.

The right solution for your product delivers a competitive edge.

One 2 One® provides a wide variety of delivery options, from vials, bottles, ampuls and prefilled syringes, to proprietary products such as iSecure™ and the ADD-Vantage™ System. It’s about developing simple solutions to streamline workflow, improve accuracy and decrease waste and costs. Have One 2 One® meet your unique product needs for a distinct advantage in the marketplace.

Successful commercialization starts 2-4 years prior to launch, right after proof-of-concept, as you move through Phase II trials. One 2 One® continually partners to guide your product from site selection and technology transfer to cold-chain management and distribution: Syringes

iSecure™ Syringe Prefilled, ready-to-use syringe is a new standard delivering efficiency and simplicity to ensure accuracy and lower costs

Ansyr™ Syringe Prefilled emergency medications in polypropylene plastic syringe with needle-free, luer-lock tip can connect to any valve

Glass Prefilled Syringes with Needle Guards

Cartridges for Pen Devices

Infusion Delivery

VisIV™ Container Premix VisIV™ containers are first to require no overwrap for 40-60% less waste (100% free of PVC and DEHP)

ADD-Vantage™ System Keeps drug and diluent separate until the system is activated so medications can be prepared quickly without needles, syringes or alcohol swabs

Flexible Containers

Packaging

Onco-Tain™ Vial Contains cytotoxic material by providing shatter resistance with a PVC bottom, surface protection with a shrink- wrapped sleeve and clarity of glass for easy inspection

Reconstitution Diluents

Kit Packaging

• Global method and process development

• Fill-finish manufacturing in the U.S., Italy, Australia and India

• Expert regulatory filing strategies for the Americas, Europe, Asia Pacific and ROW

• Custom kits and multilingual labeling and packaging

• Full product release (including QP) and stability testing

• Cold-chain management and shipping validation

Biotechnology 20+ years of biotech product experience

Analytical Full suite of analytical capabilities for wide variety of molecules

Formulation and Pharmaceutical Services Pilot and commercial scale disposable technology

Manufacturing Development and Optimization Fully functional GLP pilot plant facilities

Microbiological Services Sterilization cycle development and validation

Complete range of services from method

development and validation to impurity

identification with ImpurID™

Fulfills every product need specializing in biologics, lyophilization, cytotoxics, sterile compounding and emulsions

Product Development

Manufacturing Capabilities

iSecure™ Syringe

Your Parenteral Comfort Zone

VisIV™ Container

Page 4: Proven worldwide parenteral experience - beta.rodpub.combeta.rodpub.com/uploads/112760w_bkp_1004_One2OneBrochure.pdf · Kit Packaging • Global method and process development ...

Onco-Tain™ Vial

Start early to establish your custom comfort zone.

Comprehensive custom commercialization services Expansive global manufacturing capabilities

Rely on our success in biologic, cytotoxic and emulsion products.

One 2 One® has manufactured over 25 different large molecules for leading BioPharma clients, 15 of which are commercial products. Our innovative R&D scientists develop analytical and manufacturing methods to match unique needs for every type of product.

Innovative drug delivery & packaging options

Address every injectable product need, wherever you need it.

By centralizing global management, One 2 One® can thoroughly integrate nine state-of-the-art facilities around the world. It enables our clients to seamlessly deploy the manufacturing scale and capacity to accommodate large and small batch sizes, the world over.

The right solution for your product delivers a competitive edge.

One 2 One® provides a wide variety of delivery options, from vials, bottles, ampuls and prefilled syringes, to proprietary products such as iSecure™ and the ADD-Vantage™ System. It’s about developing simple solutions to streamline workflow, improve accuracy and decrease waste and costs. Have One 2 One® meet your unique product needs for a distinct advantage in the marketplace.

Successful commercialization starts 2-4 years prior to launch, right after proof-of-concept, as you move through Phase II trials. One 2 One® continually partners to guide your product from site selection and technology transfer to cold-chain management and distribution: Syringes

iSecure™ Syringe Prefilled, ready-to-use syringe is a new standard delivering efficiency and simplicity to ensure accuracy and lower costs

Ansyr™ Syringe Prefilled emergency medications in polypropylene plastic syringe with needle-free, luer-lock tip can connect to any valve

Glass Prefilled Syringes with Needle Guards

Cartridges for Pen Devices

Infusion Delivery

VisIV™ Container Premix VisIV™ containers are first to require no overwrap for 40-60% less waste (100% free of PVC and DEHP)

ADD-Vantage™ System Keeps drug and diluent separate until the system is activated so medications can be prepared quickly without needles, syringes or alcohol swabs

Flexible Containers

Packaging

Onco-Tain™ Vial Contains cytotoxic material by providing shatter resistance with a PVC bottom, surface protection with a shrink- wrapped sleeve and clarity of glass for easy inspection

Reconstitution Diluents

Kit Packaging

• Global method and process development

• Fill-finish manufacturing in the U.S., Italy, Australia and India

• Expert regulatory filing strategies for the Americas, Europe, Asia Pacific and ROW

• Custom kits and multilingual labeling and packaging

• Full product release (including QP) and stability testing

• Cold-chain management and shipping validation

Biotechnology 20+ years of biotech product experience

Analytical Full suite of analytical capabilities for wide variety of molecules

Formulation and Pharmaceutical Services Pilot and commercial scale disposable technology

Manufacturing Development and Optimization Fully functional GLP pilot plant facilities

Microbiological Services Sterilization cycle development and validation

Complete range of services from method

development and validation to impurity

identification with ImpurID™

Fulfills every product need specializing in biologics, lyophilization, cytotoxics, sterile compounding and emulsions

Product Development

Manufacturing Capabilities

iSecure™ Syringe

Your Parenteral Comfort Zone

VisIV™ Container

Page 5: Proven worldwide parenteral experience - beta.rodpub.combeta.rodpub.com/uploads/112760w_bkp_1004_One2OneBrochure.pdf · Kit Packaging • Global method and process development ...

Our comfort zone is here:

Whatever your injectable product needs. Wherever you need to be.

Find out how One 2 One® can help create your parenteral success.

Call +1-224-212-2267 or +44 (0) 1926 835 554, visit one2onecmo.com, or e-mail [email protected]

Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P10-2631-Apr., 10

Proven worldwide parenteral experience

Welcome to a world of parenteral expertise.

With One 2 One®, you can confidently raise your fill-finish comfort level.

By centralizing global management, One 2 One® seamlessly orchestrates

nine worldwide manufacturing facilities and comprehensive commercialization

services, including regulatory expertise in over 70 local markets. Whether a small

molecule or advanced biologic, from Phase ll through the life of your brand,

One 2 One® is your comfort zone for parenteral contract manufacturing.

Let our proud history and accomplishments be your comfort zone.

One 2 One®, a service of Hospira, was created from the global hospital products business of Abbott Laboratories and has successfully launched hundreds of parenteral products. Extraordinary quality, capacity and security of supply is ensured.

• 80+ years of manufacturing biologics and small molecules

• Practical knowledge of 70+ markets for global regulatory submissions

• A seamlessly coordinated, centralized system for global decision-making and commercialization strategies, infused with local expertise

• Experience with more than 25 different large molecules, 25 dispersed system formulations, 11 cytotoxic products and beta-lactams

• Facilities inspected by FDA, EMEA, MHRA, TGA and numerous other worldwide regulatory agencies

Facility Fill/Finish APIProduct

DevelopmentLyophilization/

Powder FillBiologics Cytotoxics

Emulsions/ Liposomes

Beta-Lactams

Adelaide, Australia l l l

Austin, Texas, USA l

Boulder, Colorado, USA l l

Clayton, North Carolina, USA l l l

Lake Forest, Illinois, USA l

Liscate, Italy l l L/P l

McPherson, Kansas, USA l l L l

Melbourne, Australia l l L l l l

Rocky Mount, North Carolina, USA l

Chennai, India l l L/P l

| Your Parenteral Comfort Zone

Page 6: Proven worldwide parenteral experience - beta.rodpub.combeta.rodpub.com/uploads/112760w_bkp_1004_One2OneBrochure.pdf · Kit Packaging • Global method and process development ...

Our comfort zone is here:

Whatever your injectable product needs. Wherever you need to be.

Find out how One 2 One® can help create your parenteral success.

Call +1-224-212-2267 or +44 (0) 1926 835 554, visit one2onecmo.com, or e-mail [email protected]

Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P10-2631-Apr., 10

Proven worldwide parenteral experience

Welcome to a world of parenteral expertise.

With One 2 One®, you can confidently raise your fill-finish comfort level.

By centralizing global management, One 2 One® seamlessly orchestrates

nine worldwide manufacturing facilities and comprehensive commercialization

services, including regulatory expertise in over 70 local markets. Whether a small

molecule or advanced biologic, from Phase ll through the life of your brand,

One 2 One® is your comfort zone for parenteral contract manufacturing.

Let our proud history and accomplishments be your comfort zone.

One 2 One®, a service of Hospira, was created from the global hospital products business of Abbott Laboratories and has successfully launched hundreds of parenteral products. Extraordinary quality, capacity and security of supply is ensured.

• 80+ years of manufacturing biologics and small molecules

• Practical knowledge of 70+ markets for global regulatory submissions

• A seamlessly coordinated, centralized system for global decision-making and commercialization strategies, infused with local expertise

• Experience with more than 25 different large molecules, 25 dispersed system formulations, 11 cytotoxic products and beta-lactams

• Facilities inspected by FDA, EMEA, MHRA, TGA and numerous other worldwide regulatory agencies

Facility Fill/Finish APIProduct

DevelopmentLyophilization/

Powder FillBiologics Cytotoxics

Emulsions/ Liposomes

Beta-Lactams

Adelaide, Australia l l l

Austin, Texas, USA l

Boulder, Colorado, USA l l

Clayton, North Carolina, USA l l l

Lake Forest, Illinois, USA l

Liscate, Italy l l L/P l

McPherson, Kansas, USA l l L l

Melbourne, Australia l l L l l l

Rocky Mount, North Carolina, USA l

Chennai, India l l L/P l

| Your Parenteral Comfort Zone