3M DRUG DELIVERY SYSTEMS

Partner with the Global Leader in Drug Delivery Systems.

Hurlingham, Argentina Manufacturing Facility

Experts at Commercializing Innovation

Drug Delivery Systems: It’s in the detail

Innovation on a Global Scale

Ingenious Solutions Transforming Health

3M is a global innovation company that never stops inventing. Over the years,

our innovations have improved daily life for hundreds of millions of people and

businesses all over the world. Every day at 3M, one idea always leads to the next,

igniting momentum to make progress possible around the world. On average, every

person will come into contact with a 3M product or technology 17 times a day.

As a pioneer in the development of intuitive, patient-friendly technology, 3M understands how to

deliver life saving medication. From development to commercial scale manufacturing, we have over

50 years of knowledge and innovation that goes into everything we do. You can’t always see our

innovation, but look again, because it is there—in the detail.

3M Microstructured Transdermal Systems

(MTS) offer patient-friendly solid and

hollow microneedle technology. By offering

patients the efficiency of a syringe with

the comfort and convenience of a patch,

these technologies can help increase the

commercial success of your product.

A transdermal form of your drug can

help to differentiate your product while

offering patients a more comfortable,

convenient and effective way to receive

their medications.

3M is your low-risk contract manufacturing

partner for a broad range of oral and

topical dosage forms, offering security,

service and sound value with end-to-end

solutions you can trust.

3M Scotchpak™ Packaging Films can

withstand every part of the product lifecycle

delivering a high level of confidence, even

for the most challenging applications.

Having created the first metered dose

inhaler (MDI) over 50 years ago, 3M has

the experience and expertise to help

commercialize your product. We offer

MDIs with the 3M™ Integrated Dose by

Dose Counters, a full range of inhaler

components, and provide both pressure-

and cold-fill contract manufacturing.

Featuring no-drip aerosol delivery,

3M™ Nasal MDI technology is ideal for

partners wanting a rapid, cost-effective

extension of their inhaled product and

for those seeking a device edge for new

nasal treatments.

With subsidiaries in more than 70 countries and

operations in nearly 200 countries, 3M is truly a

global company. Currently, 3M offers more than

60,000 products which generate sales in excess

of US$ 30 billion. And with almost 90,000

employees worldwide, 3M has local presence

across its global markets. 3M has five global

business groups, one of which is Health Care.

With a depth of diverse technologies, a culture of

collaboration and a global footprint, 3M Health Care

is a leader in delivering innovative solutions. As

the creators of the metered dose inhaler, the Drug

Delivery Systems division has a proven history of

inhalation delivery. At 3M Health Care and 3M Drug

Delivery Systems, our innovations help improve the

quality, cost and outcomes of care.

Worldwide Manufacturing Facilities Capabilities

St. Paul, MN

Inhalation – Cold-�ll

Inhalation – Pressure-�ll

Transdermal

Oral/Topical

Pilot scale

Small scale

Intermediate scale

Large, commercial scale

ISO-7 certi�ed

DEA CII-CV compliant

Clinical supply

manufacturing

Toxicology supply

manufacturing

Inspections

Northridge, CA

Loughborough, UK

Hurlingham, AR

FDA, MHRA FDA, MHRA FDA, MHRA MERCOSUR,INVIMA

Inhalation Reducing the risk of commercializing innovation

Oral & Topical A partner you can trust, quality you can count on

TransdermalOptimize delivery and increase patient comfort

Packaging Films Reliable packaging delivers confidence

Nasal Gain an edge in your nasal market

MicroneedleIncreasing commercial success with patient-friendly solutions

Consumer

Electronics & Energy

Health Care

Industrial

Safety & Graphics

3M Hurlingham, Argentina: Local Knowledge, Global Resources

Technical Expertise to Get You to Market Faster

High Quality Production and Reliable Supply

With more than 30 years of knowledge, experience and success in Latin America,

3M Hurlingham offers a dedicated local team backed by a truly global support

network. We can navigate cultural barriers, provide custom technical dossiers

and help you understand requirements and filing processes, not only within Latin

America but across global markets.

Let our highly responsive local team reduce the risk of commercializing your

next metered dose inhaler. With state-of-the-art cGMP pressure-fill and cold-fill

capabilities, global regulatory support and an MDI product portfolio covering

Latin America’s needs, we are the trusted local partner of choice.

3M understands metered dose inhaler (MDI) manufacturing from start to finish.

We ask better questions and use Lean Six Sigma processes to get you ready

for market faster. Because we offer both pressure-fill and cold-fill for MDI

manufacturing, 3M leverages the most appropriate processing method for

your product. We also provide custom micronizing, or particle size reduction,

to obtain particles in the respirable range. Our filling capabilities can handle

any size project from clinical to commercial supply.

With a culture that demands continuous improvement, 3M is the reliable

choice for cGMP compliant MDI manufacturing. We are always looking for

ways to maximize efficiencies. Whether it’s through better supply chain

management, reinvestment in new technologies or Lean Six Sigma processes,

our goal is to streamline operations, eliminate variation and give our

customers a competitive edge.

• MDI pressure-fill and cold-fill capabilities

• Micronization and powder handling technologies

• Strategically located filling sites with supply and distribution to global markets

• Globally-compliant facilities that are always audit ready

• Automated aerosol filling and packaging lines including small-order packaging flexibility

We are experts at commercializing innovation. So with our proven technical,

regulatory and production experience, you can proceed with total confidence.

Our team has the experience, capacity, and extensive quality and regulatory expertise to support our

customers through every step of the product commercialization process:

• Screening one or more compounds for compatibility with one

of our drug delivery technologies.

• Evaluating formulation, process and component variables in

the feasibility phase.

• Feasibility studies provide partners with confidence to progress

to full product development and commercial scale up.

• cGMP contract manufacturing capabilities offering flexible

batch sizes to support market needs.

• Regulatory support with a proven track record including

four single-cycle FDA reviews in five years.

• Local presence, with a deep understanding of the unique

culture and regulatory processes in the region.

• Vertical integration providing flexibility, speed and reliability

for a seamless and cost-effective customer experience.

• Proven experience bringing a wide range of branded and

generic inhaled drug products to market in Latin America.

Laboratory

Formulation Development

Early PhaseDevelopment

FullDevelopment

CommercialSupply

Pilot Facility Commercial Facility

Assess feasibility of delivering

API through solubility,

compatibility and prototype

system pharma performance

Re�ne the system for

optimum performance,

product toxicology and

early clinical supplies

• Finalize design

• Complete method

validation

• Scale up process

• Produce late-stage

clinical supplies

• Complete registration

stability

• Submit regulatory

dossier

• Produce validation &

launch supplies

Certifications:

• ANMAT (Argentina)

• INVIMA (Colombia)

• Mercosur (Argentina,Brazil, Paraguay,Uruguay & Venezuela)

• ISO 14001 and OHSAS18001 (EHS)

At 3M Hurlingham, we are experts at commercializing innovation.

Drug Delivery Systems: It’s in the detail

Innovation on a Global Scale

Ingenious Solutions Transforming Health

3M is a global innovation company that never stops inventing. Over the years,

our innovations have improved daily life for hundreds of millions of people and

businesses all over the world. Every day at 3M, one idea always leads to the next,

igniting momentum to make progress possible around the world. On average, every

person will come into contact with a 3M product or technology 17 times a day.

As a pioneer in the development of intuitive, patient-friendly technology, 3M understands how to

deliver life saving medication. From development to commercial scale manufacturing, we have over

50 years of knowledge and innovation that goes into everything we do. You can’t always see our

innovation, but look again, because it is there—in the detail.

3M Microstructured Transdermal Systems

(MTS) offer patient-friendly solid and

hollow microneedle technology. By offering

patients the efficiency of a syringe with

the comfort and convenience of a patch,

these technologies can help increase the

commercial success of your product.

A transdermal form of your drug can

help to differentiate your product while

offering patients a more comfortable,

convenient and effective way to receive

their medications.

3M is your low-risk contract manufacturing

partner for a broad range of oral and

topical dosage forms, offering security,

service and sound value with end-to-end

solutions you can trust.

3M Scotchpak™ Packaging Films can

withstand every part of the product lifecycle

delivering a high level of confidence, even

for the most challenging applications.

Having created the first metered dose

inhaler (MDI) over 50 years ago, 3M has

the experience and expertise to help

commercialize your product. We offer

MDIs with the 3M™ Integrated Dose by

Dose Counters, a full range of inhaler

components, and provide both pressure-

and cold-fill contract manufacturing.

Featuring no-drip aerosol delivery,

3M™ Nasal MDI technology is ideal for

partners wanting a rapid, cost-effective

extension of their inhaled product and

for those seeking a device edge for new

nasal treatments.

With subsidiaries in more than 70 countries and

operations in nearly 200 countries, 3M is truly a

global company. Currently, 3M offers more than

60,000 products which generate sales in excess

of US$ 30 billion. And with almost 90,000

employees worldwide, 3M has local presence

across its global markets. 3M has five global

business groups, one of which is Health Care.

With a depth of diverse technologies, a culture of

collaboration and a global footprint, 3M Health Care

is a leader in delivering innovative solutions. As

the creators of the metered dose inhaler, the Drug

Delivery Systems division has a proven history of

inhalation delivery. At 3M Health Care and 3M Drug

Delivery Systems, our innovations help improve the

quality, cost and outcomes of care.

Worldwide Manufacturing Facilities Capabilities

St. Paul, MN

Inhalation – Cold-�ll

Inhalation – Pressure-�ll

Transdermal

Oral/Topical

Pilot scale

Small scale

Intermediate scale

Large, commercial scale

ISO-7 certi�ed

DEA CII-CV compliant

Clinical supply

manufacturing

Toxicology supply

manufacturing

Inspections

Northridge, CA

Loughborough, UK

Hurlingham, AR

FDA, MHRA FDA, MHRA FDA, MHRA MERCOSUR,INVIMA

Inhalation Reducing the risk of commercializing innovation

Oral & Topical A partner you can trust, quality you can count on

TransdermalOptimize delivery and increase patient comfort

Packaging Films Reliable packaging delivers confidence

Nasal Gain an edge in your nasal market

MicroneedleIncreasing commercial success with patient-friendly solutions

Consumer

Electronics & Energy

Health Care

Industrial

Safety & Graphics

3M Hurlingham, Argentina: Local Knowledge, Global Resources

Technical Expertise to Get You to Market Faster

High Quality Production and Reliable Supply

With more than 30 years of knowledge, experience and success in Latin America,

3M Hurlingham offers a dedicated local team backed by a truly global support

network. We can navigate cultural barriers, provide custom technical dossiers

and help you understand requirements and filing processes, not only within Latin

America but across global markets.

Let our highly responsive local team reduce the risk of commercializing your

next metered dose inhaler. With state-of-the-art cGMP pressure-fill and cold-fill

capabilities, global regulatory support and an MDI product portfolio covering

Latin America’s needs, we are the trusted local partner of choice.

3M understands metered dose inhaler (MDI) manufacturing from start to finish.

We ask better questions and use Lean Six Sigma processes to get you ready

for market faster. Because we offer both pressure-fill and cold-fill for MDI

manufacturing, 3M leverages the most appropriate processing method for

your product. We also provide custom micronizing, or particle size reduction,

to obtain particles in the respirable range. Our filling capabilities can handle

any size project from clinical to commercial supply.

With a culture that demands continuous improvement, 3M is the reliable

choice for cGMP compliant MDI manufacturing. We are always looking for

ways to maximize efficiencies. Whether it’s through better supply chain

management, reinvestment in new technologies or Lean Six Sigma processes,

our goal is to streamline operations, eliminate variation and give our

customers a competitive edge.

• MDI pressure-fill and cold-fill capabilities

• Micronization and powder handling technologies

• Strategically located filling sites with supply and distribution to global markets

• Globally-compliant facilities that are always audit ready

• Automated aerosol filling and packaging lines including small-order packaging flexibility

We are experts at commercializing innovation. So with our proven technical,

regulatory and production experience, you can proceed with total confidence.

Our team has the experience, capacity, and extensive quality and regulatory expertise to support our

customers through every step of the product commercialization process:

• Screening one or more compounds for compatibility with one

of our drug delivery technologies.

• Evaluating formulation, process and component variables in

the feasibility phase.

• Feasibility studies provide partners with confidence to progress

to full product development and commercial scale up.

• cGMP contract manufacturing capabilities offering flexible

batch sizes to support market needs.

• Regulatory support with a proven track record including

four single-cycle FDA reviews in five years.

• Local presence, with a deep understanding of the unique

culture and regulatory processes in the region.

• Vertical integration providing flexibility, speed and reliability

for a seamless and cost-effective customer experience.

• Proven experience bringing a wide range of branded and

generic inhaled drug products to market in Latin America.

Laboratory

Formulation Development

Early PhaseDevelopment

FullDevelopment

CommercialSupply

Pilot Facility Commercial Facility

Assess feasibility of delivering

API through solubility,

compatibility and prototype

system pharma performance

Re�ne the system for

optimum performance,

product toxicology and

early clinical supplies

• Finalize design

• Complete method

validation

• Scale up process

• Produce late-stage

clinical supplies

• Complete registration

stability

• Submit regulatory

dossier

• Produce validation &

launch supplies

Certifications:

• ANMAT (Argentina)

• INVIMA (Colombia)

• Mercosur (Argentina,Brazil, Paraguay,Uruguay & Venezuela)

• ISO 14001 and OHSAS18001 (EHS)

At 3M Hurlingham, we are experts at commercializing innovation.

Capabilities

• Modern, state-of-the-art current Good Manufacturing

Practices (cGMP) facility (opened in 2006)

• ISO 6 class clean areas in manufacturing and ISO 7 class in

packaging

• Controlled temperature and humidity

• Cold-filling and pressure-filling (one step) capabilities

• Closed manufacturing processes, reactors fitted with

Clean-In-Place (CIP)

• Automatic filling under class 3 laminar flow

• 100% aerosols tested by automatic valve spray testing and

dynamic weight checker

• Automatic and semi-automatic packaging process

Technical Services

• Product formulation

• Analytical Methods Development and Validation

• Process scale-up and validation

• Stability studies in different climatic zones

• Preparation of Technical Dossier for Regulatory Submission

Analytical Laboratory

• Physical-Chemical Laboratory

• New generation instrumental: High Performance Liquid

Chromatography (HPLC), Gas Chromatography (GC),

ultrapure water generator, Mastersizer particle size analyzer,

ultra analytical scale, Andersen cascade impactor, stability

chambers for different climatic conditions

Microbiological Laboratory

• Bio-security cabinet, autoclave and incubators

Quality Assurance

• World class quality systems implemented

• Finished product complete release

• Lean Six Sigma

• Complaints Management

• Change Management

• Deviations and Quality Incidents Management

• Internal and Supplier Audits

• Corrective and Preventive Actions (CAPAs)

• Annual Product Review

Materials & Warehouses

• Validated systems for materials management

• Clean sampling area ISO 6 class

• Temperature-controlled warehouse (<25°C/<77ºF)

• 200 standard locations expandable to 800+

• Flammable products warehouse

• Use of heat treated wooden pallets

3M Hurlingham Capabilities, Services and Quality Control

From Start to Finish, 3M is the Best Partner for All Your MDI Manufacturing Needs:

• 3M is a stable company to select for your product supply

• 3M has the global capacity for development and commercial manufacturing

• 3M has a commitment to quality and continuous improvement

3M has over five decades of proven success in MDI development, manufacture and

delivery to market. Contact us at 3M.com/DDS to receive an initial, cost-free paper feasibility

assessment and to begin partnering with us to commercialize your MDI innovation.

Capabilities

• Modern, state-of-the-art current Good Manufacturing

Practices (cGMP) facility (opened in 2006)

• ISO 6 class clean areas in manufacturing and ISO 7 class in

packaging

• Controlled temperature and humidity

• Cold-filling and pressure-filling (one step) capabilities

• Closed manufacturing processes, reactors fitted with

Clean-In-Place (CIP)

• Automatic filling under class 3 laminar flow

• 100% aerosols tested by automatic valve spray testing and

dynamic weight checker

• Automatic and semi-automatic packaging process

Technical Services

• Product formulation

• Analytical Methods Development and Validation

• Process scale-up and validation

• Stability studies in different climatic zones

• Preparation of Technical Dossier for Regulatory Submission

Analytical Laboratory

• Physical-Chemical Laboratory

• New generation instrumental: High Performance Liquid

Chromatography (HPLC), Gas Chromatography (GC),

ultrapure water generator, Mastersizer particle size analyzer,

ultra analytical scale, Andersen cascade impactor, stability

chambers for different climatic conditions

Microbiological Laboratory

• Bio-security cabinet, autoclave and incubators

Quality Assurance

• World class quality systems implemented

• Finished product complete release

• Lean Six Sigma

• Complaints Management

• Change Management

• Deviations and Quality Incidents Management

• Internal and Supplier Audits

• Corrective and Preventive Actions (CAPAs)

• Annual Product Review

Materials & Warehouses

• Validated systems for materials management

• Clean sampling area ISO 6 class

• Temperature-controlled warehouse (<25°C/<77ºF)

• 200 standard locations expandable to 800+

• Flammable products warehouse

• Use of heat treated wooden pallets

3M Hurlingham Capabilities, Services and Quality Control

From Start to Finish, 3M is the Best Partner for All Your MDI Manufacturing Needs:

• 3M is a stable company to select for your product supply

• 3M has the global capacity for development and commercial manufacturing

• 3M has a commitment to quality and continuous improvement

3M has over five decades of proven success in MDI development, manufacture and

delivery to market. Contact us at 3M.com/DDS to receive an initial, cost-free paper feasibility

assessment and to begin partnering with us to commercialize your MDI innovation.

About 3M Argentina3M Argentina was founded in 1952 and was the eighth subsidiary outside

the United States. We have local manufacturing operations in Buenos

Aires and Tierra del Fuero provinces, a distribution center as well as the

new Innovation and Technology Development Center in Buenos Aires.

3M Drug Delivery Systems

3M Argentina

Los Arboles 842, Hurlingham (1686)

Buenos Aires, Argentina

(54) 11 4469 8259

3M.com/DDS

3M Drug Delivery Systems

3M House

Morley Street

Loughborough, Leicestershire

LE11 1EP England

(44) 1509 613626

Fax (44) 1509 613099

3M.com/DDS

3M Drug Delivery Systems

3M Center

Building 275-03-E-10

St. Paul, MN USA 55144-1000

(1) 800-643-8086

Fax (1) 651-737-5265

3M.com/DDS

3M Drug Delivery Systems

3M Northridge

19901 Nordhoff Street

Northridge, CA USA 91324-3213

(1) 818-341-1300

Fax (1) 818-709-3055

3M.com/DDS

3M Drug Delivery SystemsExperts at Commercializing Innovationwww.3M.com/DDS

3M is a trademark of 3M Company.©3M 2014.

All Rights Reserved. 70-2009-7913-9

Additional 3M Drug Delivery Systems Facilities

Versión en español disponible