MDI Manufacturing Services
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1 MDI Manufacturing Services Presenter, Date
2 Who we are 3M Drug Delivery Systems is a division of 3M dedicated to working together with pharmaceutical and biotech companies to bring new and improved products to market, leveraging 3M s proprietary technology. 50-year track record in pharmaceutical product development and manufacturing. Continuing to solve problems with innovative solutions and delight customers with our quality, products, services and interactions. 2
3 MDI specialists from start to finish MDI pioneer, with over 50 years track record helping our customers succeed: First MDI First CFC-free MDI First single-cycle FDA review First FDA-approved* integrated dose counter available to clients. Trusted MDI manufacturer - 50% of all metered-dose inhalers worldwide utilise 3M drug delivery technology. Committed to helping customers to successfully bring cost effective, high quality, patient friendly products to market that will improve patient s lives. Global team of experts passionate about making progress possible for our clients. * In conjunction with an MDI product 3
4 Our MDI manufacturing approach Our responsive, flexible and collaborative approach to proactive problem solving delivers speed to market. With global capabilities and years of MDI manufacturing experience 3M helps make progress possible for customers. Operate in a safe, compliant, accountable and environmentally responsible manner while fostering an innovative environment. Lean Six Sigma methodology and cgmp compliant manufacturing make 3M the reliable choice for your Metered Dose Inhaler (MDI) products. 4
5 Product development and manufacturing Laboratory Pilot Facility Commercial Facility Formulation Development Process Development Scale Up Commercial Supply Your Drug Feasibility Development Scale-Up Commercial Launch/Supply Your Formulation Tech Transfer Site Qualification Commercial Supply Your product Tech Transfer Site Qualification Commercial Supply From From the complete the complete development development and manufacturing and manufacturing cycle, cycle, to specific to product specific manufacturing product needs, manufacturing 3M is fully needs, flexible 3M to is meet fully flexible your requirements. to meet your requirements. 5
6 Trusted manufacturer for your global MDI needs Global capacity and flexibility to produce required volumes for developed and emerging markets. Lean Six Sigma drives product and process understanding and efficiency through all processes to help customers improve competitive edge. Team of international quality and regulatory experts to ensure compliance. Corporate strength and industry relationships make supply chain management efficient and strong. Access to corporate experts helps ensure technical challenges are addressed with tangible solutions. 6
7 Flexible solutions to meet market changes Increased demand. Market opportunity. Failure of another supplier. 3M is equipped to meet your needs, no matter what the situation. 3M s flexible approach and customised processes Enable you to react to market opportunities or respond to increased demand Improves your product s chances for success 7
8 Full range of cgmp compliant services State-of-the-art fully automated Pamasol filling lines for commercial supply Analytical method development, validation, raw material and finished product testing Semi automated pilot-scale lines for toxicology and clinical supplies ICH and customer stability programs MDI pressure- and cold-filling capabilities at both pilot and commercial scale Scale-up and registration support Component manufacturing and supply Potent and controlled substance compound handling 8
9 Manufacturing Facilities 9
10 St Paul, Minnesota - USA Product and Process Development to Pilot Scale Pilot and small to intermediate commercial scale manufacturing Process configurations enable small batch sizes to conserve costly or limited API supplies Clinical and toxicological supply manufacturing Pressure- and cold-filling Single and two stage filling methods 1/3 scale of commercial batch size Potent compound handling Pamasol LB-20 Macromat DEA registrations: 2, 3 & 3N St Paul, MN Northridge, CA Hurlingham, AR Clitheroe, UK Loughborough, UK 10
11 Northridge, California - USA St Paul, MN Northridge, CA Clitheroe, UK Loughborough, UK Large Commercial Scale Pressure-filling Cold- filling High speed packaging Supplying tens of millions of units annually Potent compound handling and size reduction Modern quality control laboratory ISO certification DEA registrations Hurlingham, AR 11
12 Loughborough - UK St Paul, MN Northridge, CA Clitheroe, UK Loughborough, UK Pilot to Large Commercial Scale Cold-filling with potential to expand into pressure-filling High speed packaging Supplying tens of millions of units annually Potent compound handling and size reduction ISO 9001:2008 & ISO 13485:2003 certified manufacturing facility Hurlingham, AR 12
13 Hurlingham - Argentina St Paul, MN Northridge, CA Clitheroe, UK Loughborough, UK Large Commercial Scale Cold-filling millions of units annually ISO Hurlingham, AR 13
14 Clitheroe - UK St Paul, MN Northridge, CA Clitheroe, UK Loughborough, UK Components manufacturing Deep drawing and assembly of valves and canisters Elastomer extraction ISO 9001:2008 Hurlingham, AR 14
15 Manufacturing site summary Strategically located MDI filling sites with supply to global markets Commercial sites focused on quality, service, efficiency and customer relationships Pilot facilities focused on experimentation and quality optimization Capacity to meet a wide range of customer needs Global capacity: 65MM to 100MM by 2015 Capability to support product development through commercialization with a proven track record 15
16 Quality And Regulatory 16
17 Commitment to quality and improvement Undertake regular self-audits. Lean Six Sigma is embedded in manufacturing and quality processes to drive continual improvements. Commitment to total productive maintenance. Deep product and process understanding. Vast experience ensures quality by design. Operate to global standard operating procedures. Employ process analytical technology. Utilise global electronic systems for change and issue management. Accredited quality professionals. 17
18 Continuous quality and innovation Lean Six Sigma is embedded in 3M s everyday ways of working, making our processes robust, driving out waste and streamlining operations to contain costs Continuous stream of innovative solutions Meticulously planned, efficient product launches Shortened cycle times for new opportunities Deliver a competitive advantage for ourcustomers 18
19 Regulatory support Long history of success in filings worldwide (IND, ANDA, NDA, DMF). Experience ranging from sponsoring entire submissions, to preparing CMC packages, and more. Multiple active programs at different stages of development ensuring alignment with current global regulatory guidances. Our global regulatory experts ensure compliance and efficient, effective submissions. 19
20 Summary 20
21 Why choose 3M? Global capacity, flexibility and continuous problem solving approach to handle any customer request Automation for speed, efficiency and quality Reputation for delivering consistent high quality Outstanding record for compliance Complementary services including Regulatory and Analytical Services Financial stability Engineering solutions for process design and manufacturability Embedded Lean Six Sigma methodology In-house release testing Global quality systems and accredited experts Leverage corporate resources and expertise in broad technologies and innovative solutions 21
22 Summary From Start to Finish, 3M s expert MDI capabilities help make success possible for our customers. See how we can help take your MDI business to the next level. 22
23 Contact us 3M Drug Delivery Systems US: (1) UK: (44) Japan: (81) Singapore: (65) China: (86) Argentina: (54) India: (91) Thank You 23
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