Brazil: A Global Biotech Hub

Transcription

1 Brazil: A Global Biotech Hub Single Use Devices Enables Bioprocessing for Domestic Biologics, Biosimilars, Export Mathew Cherian Ph.D. Director Pharmaceutical Development Hospira, Inc. USA

2 Brazil s Potential as Global Biotech Hub Brazil as Biopharma Hub 9th largest pharmaceutical market in the world, growing 12% annually 89 Biotech companies dedicated to Human Health* (BIOMINAS study) 271 Biosciences enterprises Biotech continues expansion; a leader in agribusiness Economic conditions leverage scientific base, millions of middle class Brazil has established demand for higher value products Solving Healthcare Financing in Brazil Brazil wants to participate in the emerging biosimilar market Brazil released regulatory guidance for biosimilars Brazilian health deficit US$ 3.4 Billion! 137% growth in 5 years Ministry of Health spends U$1 billion/ year on drugs; biopharmaceuticals are 41% of yearly budget

3 Brazil Current Biopharma Facilities [Latin America has 6.9% of world capacity] Source: BioPlan s website

4 MACRO TRENDS IN BIOPHARMA

5 Biopharma Markets Worldwide Biopharma (drug) market >$165 billion/year 15% growth Bioprocess supply (supplies to biopharma manufacturers) an $11 billion industry

6 Macro Trends in BioManufacturing Biosimilars Needs 25% more facilities Focus on productivity Fewer blockbusters smaller scales; less need for big fixed stainless steel facilities Individualized therapies Global standardization of products/processes 2nd-source facilities mfg. & serving as backups Internationalization major biopharmas manufacturing worldwide

7 Facility Trends (new facilities) Multi-product facilities Flexible Facilities Mostly using single-use systems More continuous processing, e.g., perfusion More focus on productivity, e.g., higher expression levels More interest in automation better process control, lower costs More monitoring more data, more problems found/fixed (PAT) More modeling more efficient processes

8 BIO/PHARMA OPERATIONAL CHANGES

9 It s NOT just about Cost anymore Operational Changes Internal Changes; % indicating Greater / Much Greater It s about Productivity Source: 9 th Annual Report and Survey of Biomanufacturing, BioPlan Associates, Inc, April 2012

10 Factors Creating Improvements in Biomanufacturing Improvement s due to: Process Control & Single-Use

11 BENEFITS FROM SINGLE USE, AND MODULAR FACILITIES

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13 Single Use Enables Brazilian Global Bioprocessing Presence SUS Reduces Facility footprint 40% or more (Xcellerex) Capital cost is 65% less [for FlexFactory] than comparable fixedpipe stainless steel facility Single-use systems can speed up by offsite commissioning and operator training, and reduce a project timeline by up to 40%. (CRB, biopharma architecture) Construction time: SUS vs Stainless shortened by at least 2 months (BPTC)

14 Facility Costs Reduced Significantly BPTC

15 Biopharma Manufacturing Scales by Phase of Dev. (SUS currently dominates all but commercial product manufacturing)

16 Single-Use Systems - Desirability 50% Capital Reductions 37% Total Cost of Goods Savings 50% Labor Reductions 90% Water Savings 50% Chemical Usage Reduction

17 Summary of Benefits SUS vs. Fixed Stainless Steel Lower facility costs; lower up-front costs Much less, simpler infrastructure, e.g., no steam piping, less space, simpler buildings, fewer staff needed No cleaning/steam sterilization faster turnaround Flexibility buy as needed; plug-and-play; multiple products manufactured in same space Faster/ leaner manuf. days vs. weeks batch turnover Regulatory aspects simpler everything sterile; same equipment others are using (vs. custom SS plant) Vendors now offer bioprocess design, equip. specification, complete pre-validated manuf. systems and training Scaleability For large quantities (kgs.), e.g., mabs, use multiple L bioreactor-based lines in parallel

18 SUS Advantages and Limitations

19 Costs for New SS vs. SUS cgmp Manuf. Facilities [Note, 62% cost savings; multiple 250 L feeder/1000 L bioreactor lines in parallel]

20 Savings/gram product, SUS vs SS facility [Note, only major higher cost is consumables]

21 FUTURE OF SINGLE USE BIOMANUFACTURING

22 Single-use Systems (SUS) Situation SUS has become the industry standard at clinical scale SUS Adoption: Growing at 6-27%, by device SUS: 85% of smaller-scale/pre-commercial Stainless Steel: 85% of commercial-scale market New facilities SUS 50/50 split next 5-10 years Increasingly, new facilities will be SUS Modular bioprocessing units and entire pre-fabricated facilities starting to enter market

23 Future Growth of Single-Use Commercial Market Single-use upstream commercial systems: From $150 million to $1.5 Biotherapeutics billion in 5 years (12% of total upstream equipment) will double in 5 years GMP SUS will grow 10x in 5 years! Source: 9 th Annual Report and Survey of Biomanufacturing, BioPlan Associates, Inc, April 2012

24 Fully Single-Use Adoption: 46% expect a fully SUS facility in 5 years

25 TRENDS IN SINGLE USE BIOPROCESSING

26 Applications where SUS Used

27 Growth Rate for SUS (first usage within a Facility)

28 Where SUS Recently Implemented

29 Average Estimated % Single Use

30 Operational Reasons for Increasing Use of Disposables Issues Strategic Decreasing in Issues Importance Increasing in Importance: SUS Enables

31 Reasons for Not Using and Disposables ( ) Leachables Extractables Not Going Away Fear of Single Source Vendor Creating Problems

32 Budget Growth, SUS Components

33 STANDARDIZATION ISSUES

34 Single Use Vendor Satisfaction

35 Vendor Satisfaction vs Importance 74% NOT Satisfied Standardizing Very Important to 75%

36 SUS VENDORS MUST WORK HARDER TO STANDARDIZE: 85% Want Connectability (Single Source Issue)

37 Why Standardize SUS? (Plug-and-Play) Less operator training needed More reliability, fewer components, adapters, failure points Interchangeability of components from alternate vendors in equipment train Less reliance on single vendor! Important in bioprocessing

38 SINGLE USE ENABLES MORE CONSISTENT GLOBAL PRODUCTION

39 Country Selections as Destination for International BioManufacturing (All Respondents) USA Germany Singapore India United Kingdom Ireland Austria Australia China Israel Sweden Switzerland France Netherlands Scotland Belgium Japan Italy Russia Holland Spain Denmark Puerto-Rico Korea Malaysia Hungary Canada Turkey Brazil

40 Possible Offshoring Destinations, INTERNATIONAL expansion over next 5 years

41 New Product Development Areas of Interest Top 4 of 21

42 Top NEW TECHNOLOGIES Vendors working on 6 of 7 are single-use

43 FUTURE OF FLEXIBLE, MODULAR BIOMANUFACTURING

44 Modular Systems Modular Systems In higher demand SUS/Equipment (pre)installed in modular units Installed in skids/trailers Offered plug-and-play at unit process level Needs / Opportunities: Better connections Integration & Automation Better sensors/monitoring

45 Flexible Facilities & SUS: Current Situation Modular increases flexibility; a critical issue today Half of new facilities have elements of modular construction Continued growth as biopharma adopts enabling SUS, and modular components, isolators, etc SUS bioreactors enabling flexible manufacturing Mid-tier biopharma early adopters; they lack legacy equipment Emerging Bioprocessing Regions are early adopters Regulators support operations that offer higher quality at reduced risk (SUS and modular facilities)

46 Reasons for Increasing SUS Use Flexibility, Modular ( )

47 Summary of SUS and Modular Facilities Adoption of flexible/modular facilities is here Modular accelerate global proliferation of commercial manufacturing, esp to emerging biopharma regions Lack of standardization continues to inhibit growth Vendors are increasingly expected to address basic standards issues

48 Summary: Brazil s Biopharma Infrastructure Brazil must expand its biopharma industry Brazilian infrastructure supports high-tech products and worldclass manufacturing Gov t-funded institutes/companies produce much domestic vaccines, some biogenerics Domestic biopharma market can support local manufacturing, particularly for biogenerics and vaccines 3 facilities among top 100 of the Top1000 (insulins plant plus gov t vaccines and biogenerics facilities) More innovative biopharma R&D needed; more CROs

49 Imperatives for Brazilian Biopharma Emergence SUS allows flexibility needed (plus lower costs) for Brazil to become a major biopharmaceutical manufacturer SUS can reduce Brazilian imports of biologics Take advantage of SUS lower startup and operational costs Faster startup SUS/modular facilities installed in weeks/months vs. years for new dedicated SS facilities Regulatory issues minimized use same pre-sterilized equipment as U.S./EU companies Provide flexibility facilities can make multiple products at different scales, as needed Facilities readily cloned cgmp-approved US/EU facilities; quick flex capacity, e.g., pandemic vaccines

50 Thank you