3M DRUG DELIVERY SYSTEMS About 3M Loughborough …...Drug Delivery Systems division has a proven...
Transcript of 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 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 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.
All Rights Reserved. 70-2009-7919-6
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 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
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.
MDI
• 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
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.
MDI
• 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
3M Loughborough Capabilities, Services and Quality Control
From Start to Finish, 3M is the Right Partner for All Your Manufacturing Needs:
• 3M is a stable company to select for your product supply
• 3M has the global capability for development and commercial manufacturing
• 3M has a commitment to quality and continuous improvement
3M has over five decades of proven success in drug 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 innovation.
Liquids Manufacturing• 4500 litre manufacturing plant
• Integrated bottle packaging line
• Plastic and glass bottles
Packaging• Fully segregated & flexible GMP facilities
• Full range of packaging techniques
• Blister/bottle packaging for tablets and capsules
• Cream sachet and powder sachet filling
• Liquid bottle filling
• Packing capability for tubes
• Pump filling
• Automated/semi-automated packaging solutions
Plant Analytical Laboratory• Physical-chemical laboratory
• Stability chambers (25C/60RH; 40C)
• Spectrophotometers (FTIR, UV-VIS, Hand-Held NIR)
• Compendia testing
• Full micro laboratory
Inhalation Drug Delivery• Cold filling manufacturing capabilities
• Potent compound handling and size reduction
• Clean in place (CIP) systems for quick cleanings and changeovers
• Concentrate preparation vessels with low or high shear mixing
• Batch formulation vessels with in-tank agitation and continuous recirculation to fill table
• Isolator technologies used in sampling and formulation of hazardous materials
Oral Drug Delivery (Capsules)• Extrusion & spheronisation for beads • Aqueous and solvent coating• Powder/bead encapsulation• Controlled release formulations
Oral Drug Delivery (Tablets)• Multiple granulation suites• Fluid bed and tray drying• Tablet compression
Topical Drug Delivery• Accurate dosing of small fill weights• Wide range of viscosities• Large and small sachets• Aluminium & plastic tubes• Pump filling
Business Card
Quality Assurance• World Class Pharmaceutical Global Quality Systems
Implemented (Q10)
• Finished product complete release
• Lean Six Sigma
• Change Management
• Deviations and Quality Incidents Management
• Corrective And Preventive Actions (CAPAs)
• Annual Product Review
Supply Chain Capabilities• Validation inventory management system for warehouse
and materials management
• Temperature-controlled warehouse (<25°C/<77ºF)
• Flammable products warehouse
• Use of heat-treated wooden pallets
• Established S&OP (Sales & Operations Planning) process
• In-house Packaging Engineering Team
• Site wide “Lean Management System” implementation
3M Loughborough Capabilities, Services and Quality Control
From Start to Finish, 3M is the Right Partner for All Your Manufacturing Needs:
• 3M is a stable company to select for your product supply
• 3M has the global capability for development and commercial manufacturing
• 3M has a commitment to quality and continuous improvement
3M has over five decades of proven success in drug 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 innovation.
Liquids Manufacturing• 4500 litre manufacturing plant
• Integrated bottle packaging line
• Plastic and glass bottles
Packaging• Fully segregated & flexible GMP facilities
• Full range of packaging techniques
• Blister/bottle packaging for tablets and capsules
• Cream sachet and powder sachet filling
• Liquid bottle filling
• Packing capability for tubes
• Pump filling
• Automated/semi-automated packaging solutions
Plant Analytical Laboratory• Physical-chemical laboratory
• Stability chambers (25C/60RH; 40C)
• Spectrophotometers (FTIR, UV-VIS, Hand-Held NIR)
• Compendia testing
• Full micro laboratory
Inhalation Drug Delivery• Cold filling manufacturing capabilities
• Potent compound handling and size reduction
• Clean in place (CIP) systems for quick cleanings and changeovers
• Concentrate preparation vessels with low or high shear mixing
• Batch formulation vessels with in-tank agitation and continuous recirculation to fill table
• Isolator technologies used in sampling and formulation of hazardous materials
Oral Drug Delivery (Capsules)• Extrusion & spheronisation for beads • Aqueous and solvent coating• Powder/bead encapsulation• Controlled release formulations
Oral Drug Delivery (Tablets)• Multiple granulation suites• Fluid bed and tray drying• Tablet compression
Topical Drug Delivery• Accurate dosing of small fill weights• Wide range of viscosities• Large and small sachets• Aluminium & plastic tubes• Pump filling
Business Card
Quality Assurance• World Class Pharmaceutical Global Quality Systems
Implemented (Q10)
• Finished product complete release
• Lean Six Sigma
• Change Management
• Deviations and Quality Incidents Management
• Corrective And Preventive Actions (CAPAs)
• Annual Product Review
Supply Chain Capabilities• Validation inventory management system for warehouse
and materials management
• Temperature-controlled warehouse (<25°C/<77ºF)
• Flammable products warehouse
• Use of heat-treated wooden pallets
• Established S&OP (Sales & Operations Planning) process
• In-house Packaging Engineering Team
• Site wide “Lean Management System” implementation
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 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 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.
All Rights Reserved. 70-2009-7919-6
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 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