Continuously Improving Bioprocesses: Biopharmaceutical Capabilities

Transcription

1 Continuously Improving Bioprocesses: Biopharmaceutical Capabilities

2 Pall Corporation A Legacy of Innovation Dr. David B. Pall Founded by Dr. David B. Pall in 1946, Pall Corporation has grown from a company producing filters for the airline industry, into a global leader in high-tech filtration, separation, and purification across many markets. In fact, Pall has filed over 10,000 patents since inception. 2

3 A Global Partner Headquartered in Port Washington, New York, Pall Corporation employs more than 10,000 employees at 80+ sites in 30 countries. Regional HQ Pall s Americas Presence Pall s EMEA Presence Pall s Asia Presence 3

4 Danaher Acquisition Danaher acquired Pall Corporation on Aug. 31, 2015; the Pall brand remains a stand-alone operating company. Life Sciences $2.5B Danaher (2015 Revenue: $20.5B*) Diagnostics $4.8B Water Quality $2.0B Danaher Corporation Founded in 1984 Headquartered in Washington, D.C. Launched $6B Fortive line of business in 2016 Product ID $1.6B Pall $2.8B Dental $2.9B Pall Corporation FY 15 ~$2.8B total sales ~$1.5B Life Sciences (53% of sales) ~$1B from Biopharmaceuticals division 4

5 Leading the Way in Biopharm Within Pall Life Sciences, the Biopharmaceuticals division is the largest and fastest-growing division, delivering exceptional process solutions for: Biotech Biologics (Vaccines & Plasma) Classic Pharmaceuticals 5

6 A Customer-Centric Supplier At Pall, we are inspired by our customers mission to improve global health. Our team works to deliver the exceptional products and services they need to advance patient safety, and enable healthier lives in a cleaner environment. Our portfolio of products and services is one of the most comprehensive in the industry, with intuitive technologies that customers can rely on, so they can focus on innovating for the future. 6

7 Pall Technologies Save Lives Pall technologies have played a key role in the development and manufacture of many life-saving drugs on the market today, ranging from cancer-curing monoclonal antibodies to Ebola vaccines. 7

8 Continuously Improving Health Pall is recognized as a reliable industry partner, helping to improve global health with innovative technologies and collaborations. 8

9 Continuously Improving Bioprocesses Pall continuously improves bioprocesses for customers at all phases of drug development. Our portfolio of products and services reflects a customer-centric approach with integrated systems and enabling technologies. Westborough, Massachusetts New England Center of Excellence October

10 An Essential Portfolio Pall enables integrated end-to-end bioprocessing unlike any other supplier in today s market. Pall provides complete solutions from cell culture through to formulation and filling to help get quality, lifesaving and life-improving drugs to market faster, with less upfront cost. Our total biopharm portfolio is essential to today s drug manufacturer. 10

11 Evolution in Bioprocessing The Pall portfolio is ever-evolving as the market changes, and drives towards continuous bioprocessing. Continuous Processing Integrated Unit Ops Single-Use Facilities Process Intensification IMPACT Reduced Processing time Operating costs Footprint Capital outlay Improved Facility efficiency Manufacturing flexibility 11

12 Single Use, Multiple Solutions Since 2000, Pall has diversified an industry-leading single-use products and services portfolio. Pall features the only portfolio offer on the market with bioprocessing support from upstream to downstream, and into final fill/finish phases. These technologies are proven to deliver: Expanded shift patterns Reduction of overall labor Reduction of reuse/consumable, cleaning, and validation costs Reduction of batch failure Reduction of validation requirements Integration of operations Improvement in throughput Disposable flow paths 12

13 Integrated Systems and Solutions Integrated end-to-end bioprocessing support delivers unmatched solutions, making it an essential portfolio for today s biomanufacturer. Pall s full line of single-use technologies is able to be integrated to: An integrated example: the Allegro STR Bioreactor and Stax platform can be optimized together at any scale. Provide scalable, reliable, and efficient technologies Reduce operator interaction and risk Reduce cleaning and validation requirements and costs Deliver fully validated solutions with extensive support options Guarantee supply chain security 13

14 Enabling Continuous Processing Pall DSP solutions enable truly continuous clarification and purification steps. Clarification Purification Cadence TM Acoustic Separator (CAS) Cadence BioSMB System Cell Clarification and Perfusion Continuous Multicolumn Chromatography Stax Depth Filter Capsules with Hyperion Flow Cadence In-line Concentrator (ILC) Cell Clarification Single-pass TFF Protein Concentration 14

15 Improving Downstream Processing Pall helps customers overcome critical downstream processing (DSP) challenges with comprehensive concentration and purification solutions. Pall features comprehensive continuous DSP solutions to overcome challenges, like the award-winning Cadence Inline Concentrator (ILC) single-pass tangential flow filtration (TFF) technology. The Cadence ILC delivers SPTFF performance with the simplicity of direct-flow filtration, and is able to be applied throughout various bioprocessing steps. U.S. Patents: 7,384,549B2; 7,682,511B2; 7,967,987B2; 8,157,999B2 Note: These SPF Technology patents are owned by SPF Innovations LLC. In 2009, Pall Corporation acquired an exclusive license from SPF Innovations LLC to manufacture, market and sell SPF Technology for biopharmaceutical applications. 15

16 Enabling Continuous Clarification Cadence Acoustic Separator (CAS) Pall s disruptive acoustic wave separation technology uses acoustophoretic separation for continuous removal of contaminants in a closed system with no centrifugation, delivering: Reduced depth filtration Reduced buffer use Consistent solids reduction CAS technology is effective for various cell types, including CHO cells in a continuous mab process, where CAS typically provides >90% yield for the clarification step. *On June 15, 2015, Pall announced the exclusive licensing agreement with FloDesign Sonics for acoustic wave separation, a disruptive technology for cell culture clarification for both fed-batch and perfusion applications. 16

17 Continuous Clarification in Action Cadence Acoustic Separation (CAS) Technology explained 17

18 Enabling Continuous Purification Cadence TM BioSMB Continuous Chromatography System The Cadence BioSMB* system is the only multicolumn chromatography system that makes 24-hour process development a reality, featuring: A cassette** to accommodate up to 16 column/capsule positions Single use Simple flow path *Pall announced the acquisition of the BioSMB technology platform from Tarpon Biosystems on March 31, **Cassette U.S. Patent: US B2 18

19 PASS Delivers Engineering Excellence Pall Advanced Separation Systems (PASS) deliver excellence in bioprocess engineering and project execution. Pall PASS technologies provide customers with an invaluable resource to enable: Automated operations Linear scale-up Streamlined processes 19

20 SLS Global Technical Support Pall Scientific and Laboratory Services (SLS) are a cornerstone of biopharm support. Our SLS Technical Services and Validation Laboratories have played a key role in customer support for more than 30 years, providing compatibility studies, extractable and leachable studies, particulate validation and more, as follows: SLS Centers of Excellence: State-ofthe-art analytical testing services SLS Laboratory Centers: Advanced laboratory testing, failure analysis and validation services SLS Customer Support Centers: Small lab(s) for basic testing 20

21 Key R&D Centers of Excellence Pall has global ISO9001 certified Centers of Excellence (CoE) to deliver exceptional customer support from R&D through to commercialization. Optimized scale-up technologies and support capabilities are cornerstones of the Pall Centers of Excellence. Hoegaarden, Belgium Portsmouth, UK Westborough, MA These facilities were built to streamline scientific and bioprocess development, while delivering cost and time savings. 21

22 A Human Mission Pall is ultimately driven to continuously improve everyday health. Pall Life Sciences provides cutting-edge products and services to meet the everyday needs of our customers as they seek to discover, develop and produce life-saving small- and large-molecule pharmaceuticals. Our biopharm division enables drug manufacturers with traditional, single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs. Our technology offer is also backed by industry-leading solutions support for customers from upstream to downstream, and into final fill/finish phases of drug production. To learn more, please visit: 22

23 This presentation is the copyright work product of Pall Corporation and no portion of this presentation may be copied, published, performed, or redistributed without the express written authority of a Pall corporate officer Pall Corporation