3M DRUG DELIVERY SYSTEMS About 3M Loughborough …...Drug Delivery Systems division has a proven...

About 3M LoughboroughThis 18-acre site opened in 1969. 3M Loughborough has facilities for

manufacturing, supply chain management and distribution and R&D.

We specialize in contract manufacturing of oral, topical and inhalation

drug delivery systems.

3M Drug Delivery Systems

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 and Scotchpak are trademarks of 3M Company.©3M 2014.

Additional 3M Drug Delivery Systems Facilities

3M DRUG DELIVERY SYSTEMS

Partner with the Global Leader in Drug Delivery Systems

Loughborough, United Kingdom Manufacturing Facility

Experts at Commercializing Innovation

3M Northridge

19901 Nordhoff Street

Northridge, CA USA 91324-3213

(1) 818-341-1300

Fax (1) 818-709-3055

3M.com/DDS

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 drug 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.

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

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

Packaging Films Reliable packaging delivers confidence

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.

Nasal Gain an edge in your nasal market

MicroneedleIncreasing commercial success with patient-friendly solutions

into Thousands of Ingenious Products

3M: Transforming New Ideas

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 drug 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.

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

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

Packaging Films Reliable packaging delivers confidence

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.

Nasal Gain an edge in your nasal market

MicroneedleIncreasing commercial success with patient-friendly solutions

into Thousands of Ingenious Products

3M: Transforming New Ideas

Technical Expertise to Get You to Market FasterOur 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.

• A global leader in oral and topical drug delivery, we

have the experience to maximize the potential of

your formulation.

• Post launch technical support for regulatory changes,

line extensions, and product updates.

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

• Post launch

technical support

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

High Quality Production and Reliable Supply

Certifications:• ISO 9001 (2008)

• ISO 13485 (2003)

• FDA approved (US)

• MHRA approved (EU)

• Registrations in over 60 countries

3M Loughborough, United Kingdom: Local Knowledge, Global ResourcesWith long-standing expertise in inhalation, oral and topical drug delivery,

3M Loughborough offers a dedicated local team backed by a truly global

support network. Our culture of continuous improvement, customer focus

and the ability to handle complex problems have made us a global centre

for the manufacture of inhalation, oral and topical products.

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

your next oral, topical or inhaled product. With state-of-the-art cGMP

compliant manufacturing including cold-fill capabilities as well as flexible

options for capsules, tablets, creams and gels we are ready to become your

trusted partner.

3M understands oral, topical and 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. For topical delivery, we can

handle a wide range of viscosities with packing in aluminum or plastic tubes.

We also offer delivery via large and small sachets. This convenient form allows

for dosing in small quantities—as low as 0.25g. For oral capsules we offer a

wide variety of options including controlled release formulations, aqueous

and solvent coating, powder/bead encapsulation and extrusion and

spheronisation for beads. For oral tablets we offer fluid bed and tray drying,

tablet compression and multiple compression suites. For MDI, we offer

cold-fill capabilities, nasal inhalers and dose by dose counters. Whether

it’s oral, topical or MDI, we can handle any size project from clinical to

commercial supply.

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

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

• Cold-fill capabilities

• Powder handling technologies and custom micronization

• Small to large batch, commercial scale facilities

• Globally-compliant facilities that are always audit ready

ORAL & TOPICAL

• Creams, gels, liquids, beads, capsules and tablets

• Oral, topical, buccal and sublingual

• Instant and controlled release formulations

• Pumps, blisters, bottles, sachets and tubes

• Automated and semi-automated packaging options

• High-toxicity API handling capabilities