Partner with the Global Leader in Drug Delivery Systems
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1 3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems Northridge, CA, USA Manufacturing Facility Experts at Commercializing Innovation
2 3M: Transforming New Ideas into Thousands of Ingenious Products 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. Electronics & Energy Industrial Consumer Health Care Safety & Graphics Innovation on a Global Scale 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. Ingenious Solutions Transforming Health 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.
3 Drug Delivery Systems: It s in the detail 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. Inhalation Reducing the risk of commercializing innovation Transdermal Optimize delivery and increase patient comfort Microneedle Increasing commercial success with patientfriendly solutions 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 pressureand cold-fill contract manufacturing. 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 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. Oral & Topical A partner you can trust, quality you can count on Worldwide Manufacturing Facilities Capabilities 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. Inhalation Cold-fill Inhalation Pressure-fill St. Paul, MN Northridge, CA Loughborough, UK Hurlingham, AR Transdermal Nasal Gain an edge in your nasal market Oral/Topical Pilot scale Small scale Featuring no-drip aerosol delivery, 3M Nasal MDI technology is ideal for Intermediate scale partners wanting a rapid, cost-effective extension of their inhaled product and for those seeking a device edge for new nasal treatments. Large, commercial scale ISO-7 certified DEA CII-CIV compliant Packaging Films Clinical supply manufacturing Reliable packaging delivers confidence Toxicology supply manufacturing 3M Scotchpak Packaging Films can withstand every part of the product lifecycle delivering a high level of confidence, even for the most challenging applications. Inspections FDA, MHRA FDA, MHRA FDA, MHRA MERCOSUR, INVIMA
4 3M Northridge, California: Local Knowledge, Global Resources With 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. 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. At 3M Northridge, we are experts at commercializing innovation. Laboratory Pilot Facility Commercial Facility Formulation Development Early Phase Development Full Development Commercial Supply Assess feasibility of delivering API through solubility, compatibility and prototype system pharma performance Refine 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
5 High Quality Production and Reliable Supply 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. MDI 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 TDD 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 We are experts at commercializing innovation. So with our proven technical, regulatory and production experience, you can proceed with total confidence. Certifications: ISO-7 Certified ISO and OHSAD (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
6 3M Northridge Capabilities, Services and Quality Control Inhalation Drug Delivery Cold, ambient and pressure 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 Transdermal Drug Delivery Double planetary mixers Precision coater Powder handling system Converting lines Integrated automatic cartoning lines Independent automatic cartoning line Mobile Mixer Agency Approvals/Certifications cgmp compliant manufacturing ISO certification and OHSAS (EHS) DEA CS Schedule II-IV License Class 10,000 clean room manufacturing capabilities Plant Analytical Laboratory Physical-chemical laboratory Stability chambers (25C/60RH; 40C) Spectrophotometers (FTIR, UV-VIS, Hand-Held NIR) Compendia testing Full micro laboratory 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 Stability and Reserve Programs Materials and Warehouses Validation inventory management system for warehouse and materials management Temperature-controlled warehouse (<25 C/<77ºF) Shipping errors are less than one percent Flammable products warehouse Use of heat-treated wooden pallets
7 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 Business Card 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.
8 About 3M Northridge This facility opened in 1949 as Riker Labs. 3M purchased the lab in 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 Northridge Nordhoff Street Northridge, CA USA (1) Fax (1) M.com/DDS Additional Facilities 3M Argentina Los Arboles 842, Hurlingham (1686) Buenos Aires, Argentina (54) M.com/DDS 3M Center Building E-10 St. Paul, MN USA (1) Fax (1) M.com/DDS 3M House Morley Street Loughborough, Leicestershire LE11 1EP England (44) Fax (44) M.com/DDS 3M is a trademark of 3M Company. 3M Scotchpak TM is a trademark of 3M Company. 3M All Rights Reserved Experts at Commercializing Innovation
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