3M DRUG DELIVERY SYSTEMS About 3M Northridge Partner …...manufacturing of transdermal and...

About 3M NorthridgeThis facility opened in 1949 as Riker Labs. 3M purchased the lab in

1970. From 2007 to 2013 Northridge underwent a major plant expansion

including increased automation. 3M Northridge specializes in contract

manufacturing of transdermal and inhalation drug delivery systems.

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 House

Morley Street

Loughborough, Leicestershire

LE11 1EP England

(44) 1509 613626

Fax (44) 1509 613099

3M.com/DDS

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 Argentina

Los Arboles 842, Hurlingham (1686)

Buenos Aires, Argentina

(54) 11 4469 8259

3M.com/DDS

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

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

Additional 3M Drug Delivery Systems Facilities

3M DRUG DELIVERY SYSTEMS

Partner with the Global Leader in Drug Delivery Systems

Northridge, CA, USA Manufacturing Facility

Experts at Commercializing Innovation

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.

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.

Consumer

Electronics & Energy

Health Care

Industrial

Safety & Graphics

Drug Delivery Systems: It’s in the detailAs 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.

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.

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-CIV 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

Packaging Films Reliable packaging delivers confidence

Nasal Gain an edge in your nasal market

MicroneedleIncreasing commercial success with patient-friendly solutions

into Thousands of Ingenious Products

3M: Transforming New Ideas

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.

TransdermalOptimize delivery and increase patient comfort

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.

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.

Consumer

Electronics & Energy

Health Care

Industrial

Safety & Graphics

Drug Delivery Systems: It’s in the detailAs 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.

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.

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-CIV 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

Packaging Films Reliable packaging delivers confidence

Nasal Gain an edge in your nasal market

MicroneedleIncreasing commercial success with patient-friendly solutions

into Thousands of Ingenious Products

3M: Transforming New Ideas

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.

TransdermalOptimize delivery and increase patient comfort

Technical Expertise to Get You to Market Faster

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 to ensure smooth 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

six single-cycle FDA reviews in six 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.

• A global leader in transdermal patch and component

manufacturing, 3M produces hundreds of millions of

patches each year.

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

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

High Quality Production and Reliable Supply

Certifications:• ISO-7 Certified

• ISO 14001 and OHSAD 18001 (EHS)

• DEA CS Schedule II-IV License

• FDA approved (US)

• MHRA approved (EU)

• German Regulatory Authorities

• Cal/OSHA 29CFR Title 8, 21 CFR Part 210&211, DEA 21 CRF Part 1300

3M Northridge, California: Local Knowledge, Global ResourcesWith a long history in inhalation and transdermal drug delivery, 3M Northridge

offers a dedicated local team backed by a truly global support network. We are

a trusted manufacturer for drug companies in the United States, the European

Union, Japan and South America. 3M Northridge can provide technical packages

to meet regulatory requirements and filling processes for the markets you serve.

Our responsive local team can help you reduce the risk of commercializing your

next metered dose inhaler or transdermal product. 3M offers state-of-the-art

cGMP compliant manufacturing including pressure-fill and cold-fill capabilities

as well as end-to-end transdermal production. Our experts can create the right

solution that serves patients and providers, resulting in increased potential for

product differentiation.

3M understands metered dose inhaler (MDI) and transdermal manufacturing

from start to finish. We ask better questions and use Lean Six Sigma

processes to get you ready for market faster. Offering both pressure-fill and

cold-fill for MDI manufacturing, 3M leverages the most appropriate processing

method for your product. For transdermal drug delivery (TDD), 3M offers a full

continuum of services to help ensure robust process design and final product.

3M has pioneered several advancements in transdermal systems, including

single- and multi-layer drug-in-adhesive (DIA) technologies that have become

industry standards. For both MDI and TDD, enjoy the convenience of working

with a single source supplier, where a vertically-integrated supply chain better

promotes continuity of supply.

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

choice for cGMP compliant 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.

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

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

• Pressure-fill and cold-fill capabilities

• Powder handling technologies and custom micronization

• Small to large batch, commercial scale facilities

• Globally-compliant facilities that are always audit ready

• Finished and intermediate product configurations

• Custom solutions to fit drug formulation needs

• Fast delivery and scale-up for commercialization

• World leader in the supply of transdermal patch components: backings, liners and membranes