3M Drug Delivery Systems. April 26, 2011

Transcription

1 3M MDI Manufacturing April 26, 2011

2 3M Drug Delivery Systems Drug Delivery Systems Overview 3M Drug Delivery Systems is a division of 3M that is dedicated to the development and manufacturing of inhalation products and components, through strategic partnerships, leveraging 3M s proprietary technology, knowhow and 50-year track record in pharmaceutical product development and manufacturing. 2

3 3M Drug Delivery Systems Product and Process Expertise 50 years of experience Proven track record Development of several firsts, including: MDI CFC-free MDI Multiple product NDAs and launches 3

4 MDI Manufacturing Responsiveness, proactive problem solving and global capabilities deliver speed to market. With more than 50 years of global MDI manufacturing experience, 3M is the reliable choice for cgmp compliant manufacturing of 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 Manufacture Your Molecule Feasibility Development Scale-Up Commercial Launch/Supply Your Formulation Tech Transfer Site Qualification Commercial Launch/Supply From complete manufacturing to specific needs, 3M s commercial high speed packaging lines are flexible to meet your needs. 5

6 The Reliable Choice for Your MDI Needs Capacity and flexibility to produce required volume Lean Six Sigma drives efficiency to help customers beat deadlines International quality, regulatory and supply chain management expertise helps reduce risk Corporate strength and industry relationships facilitate supply chain efficiency Access to experts helps ensure all technical challenges are addressed and resolved 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 the situation. Flexible approach to planning and execution Customized processes to meet requirements Improves speed to market Improves your products chances for success 7

8 Full Range of cgmp Compliant Services Toxicology, clinical and commercial supplies Scale-up and registration support Analytical method development, validation, raw material and finished product testing ICH and custom stability programs Flexible, commercial high speed packaging lines MDI pressure- and cold-filling capabilities Potent and controlled substance compound handling 8

9 Continued Quality and Innovation Using Lean Six Sigma, we work to make our processes robust while streamlining operations to contain costs. Consistent delivery of innovative ideas Fast launches and shortened cycle times Help reduce a client s carbon footprint Deliver a competitive advantage 9

10 Manufacturing Facilities 10

11 St. Paul, Minnesota, USA Product and Process Development to Pilot Scale Pilot and small to intermediate commercial scale manufacturing Clinical and toxicological supply manufacturing ISO-7 certified manufacturing facilities Dual cold- and pressure-filling 1/3 scale of commercial batch size Pamasol LB-20 Macromat 11

12 Northridge, California, USA Large Commercial Scale Cold- filling Pressure-filling Plant expansion (Q2 2011) 12

13 Loughborough, UK Pilot to Commercial Scale ISO-7 certified manufacturing facility Cold-filling tens of millions of units annually 13

14 Hurlingham, Argentina Large Commercial Scale Cold-filling millions of units annually 14

15 Future Cold and Pressure Fill Capabilities Facility opening in Pu Jiang, China (Planned 2012) 15

16 Manufacturing Site Summary Strategically located MDI filling sites with supply to global markets Commercial sites focused on efficiency, quality and service or pilot facilities focused on experimentation and quality optimization Capacity to meet all requirements and needs Global capacity: 65MM to 100MM by 2015 Expertise and capability to support product development through commercialization 16

17 Quality and Regulatory 17

18 Commitment to Quality and Improvement Self audits Lean manufacturing Total product maintenance Product process understanding Quality by design Global standard operating procedures Process analytical technology Global electronic systems for Issue Management Accredited quality professionals 18

19 Regulatory Support Excellent regulatory history for global product submissions (IND, ANDA, NDA, DMF) Experience ranging from sponsoring entire submissions, preparing CMC packages and more Multiple active programs at different stages supports alignment with current global regulator 19

20 Compliance Customer audits Certifications FDA, DEA, MHRA, LAGeSo, US Customs and CA State Board of Pharmacy Registrations and accreditations ISO Environmental Systems and Japanese Accreditation to Revised Japanese Pharma Law 20

21 Commercialization Advantage Proven reputation Global manufacturing presence State-of-the-art technologies Difficult-to-manufacture drug delivery technology specialization and experience Scale-up of lab processes to commercially viable manufacturing processes 21

22 Why Choose 3M? Automation for speed, efficiency and quality Capacity to handle any request Commercial high speed packaging lines Complementary services including Analytical Services for method development Compliance and reputation for quality and consistency Controlled substance handling Engineering solutions for process design and manufacturability Financial stability In-house release testing Micronizing Quality products and systems State-of-the-art and broad range of equipment 22

23 Summary From START TO FINISH, 3M is the best partner for all of your MDI manufacturing needs. 3M is a stable company to select for your product supply 3M has the global capacity for development and commercial manufacturing 3M has a commitment to quality and continuous improvement 23

24 Contact Information US: UK: +44 (0) Japan: (81) Singapore: (65) Argentina: India: China: (86)