Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous...
Transcript of Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous...
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Continuously Improving Bioprocesses:
Biopharmaceutical Capabilities
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Pall Corporation
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.
Dr. David B. Pall
A Legacy of Innovation
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A Global Partner
Pall’s Americas Presence Pall’s EMEA Presence Pall’s Asia Presence
Regional HQ
Headquartered in Port Washington, New York, Pall Corporation employs more than 10,000 employees at 80+ sites in 30 countries.
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Danaher Acquisition
Pall $2.8B
Product ID $1.6B
Dental $2.9B
Life Sciences $2.5B
Water Quality $2.0B
Diagnostics $4.8B
Danaher (2015 Revenue: $20.5B*) Danaher Corporation
Founded in 1984
Headquartered in Washington, D.C.
Launched $6B Fortive line of business in 2016
Pall Corporation FY’15
~$2.8B total sales
~$1.5B Life Sciences (53% of sales)
~$1B from Biopharmaceuticals division
Danaher acquired Pall Corporation on Aug. 31, 2015; the Pall brand remains a stand-alone operating company.
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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
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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.
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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.
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Continuously Improving Health
Pall is recognized as a reliable industry partner, helping to improve global health with innovative technologies and collaborations.
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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 2015
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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, life-
saving and life-improving drugs
to market faster, with less
upfront cost. Our total
biopharm portfolio is essential
to today’s drug manufacturer.
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Evolution in Bioprocessing
The Pall portfolio is ever-evolving as the market changes, and drives towards continuous bioprocessing.
Improved
Facility efficiency
Manufacturing flexibility
IMPACT
Continuous
Processing
Single-Use
Facilities
Process
Intensification
Integrated
Unit Ops
Reduced
Processing time
Operating costs
Footprint
Capital outlay
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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
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Integrated Systems and Solutions
Pall’s full line of single-use technologies is able to be integrated to:
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
Integrated end-to-end bioprocessing support delivers unmatched solutions, making it an essential portfolio for today’s biomanufacturer.
An integrated example: the Allegro™ STR Bioreactor and Stax™ platform can be optimized together at any scale.
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Cell Clarification and Perfusion
Continuous Multicolumn Chromatography
Single-pass TFF Protein Concentration
Cell Clarification
Clarification Purification
Enabling Continuous Processing Pall DSP solutions enable truly continuous clarification and purification steps.
CadenceTM Acoustic Separator (CAS) Cadence BioSMB System
Stax Depth Filter Capsules with Hyperion Flow Cadence In-line Concentrator (ILC)
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Improving Downstream Processing
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.
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.
Pall helps customers overcome critical downstream processing (DSP) challenges with comprehensive concentration and purification solutions.
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Enabling Continuous Clarification
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.
Cadence Acoustic Separator (CAS)
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Continuous Clarification in Action Cadence Acoustic Separation (CAS) Technology explained
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*Pall announced the acquisition of the BioSMB® technology platform from Tarpon Biosystems on March 31, 2015. **Cassette – U.S. Patent: US8920645 B2
Enabling Continuous Purification
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
CadenceTM BioSMB Continuous Chromatography System
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Pall PASS technologies provide customers with an invaluable resource to enable:
Automated operations
Linear scale-up
Streamlined processes
PASS Delivers Engineering Excellence
Pall Advanced Separation Systems (PASS) deliver excellence in bioprocess engineering and project execution.
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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 Global Technical Support
Pall Scientific and Laboratory Services (SLS) are a cornerstone of biopharm support.
SLS Centers of Excellence: State-of-the-art analytical testing services
SLS Customer Support Centers: Small lab(s) for basic testing
SLS Laboratory Centers: Advanced laboratory testing, failure analysis and validation services
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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.
These facilities were built to streamline scientific and bioprocess development, while delivering cost and time savings.
Hoegaarden, Belgium Portsmouth, UK
Westborough, MA
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A Human Mission
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: www.pall.com.
Pall is ultimately driven to continuously improve everyday health.
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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.
© 2016 Pall Corporation