23
Continuously Improving Bioprocesses: Biopharmaceutical Capabilities

Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

  • Upload
    others

  • View
    5

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

Continuously Improving Bioprocesses:

Biopharmaceutical Capabilities

Page 2: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

2

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

Page 3: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

3

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.

Page 4: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

4

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.

Page 5: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

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

Page 6: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

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.

Page 7: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

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.

Page 8: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

8

Continuously Improving Health

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

Page 9: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

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 2015

Page 10: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

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, life-

saving and life-improving drugs

to market faster, with less

upfront cost. Our total

biopharm portfolio is essential

to today’s drug manufacturer.

Page 11: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

11

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

Page 12: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

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

Page 13: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

13

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.

Page 14: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

14

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)

Page 15: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

15

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.

Page 16: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

16

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)

Page 17: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

17

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

Page 18: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

18

*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

Page 19: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

19

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.

Page 20: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

20

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

Page 21: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

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.

These facilities were built to streamline scientific and bioprocess development, while delivering cost and time savings.

Hoegaarden, Belgium Portsmouth, UK

Westborough, MA

Page 22: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

22

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.

Page 23: Continuously Improving Bioprocesses: Biopharmaceutical ... · single-use, and continuous technologies that have a direct impact on advancing the production of new life saving drugs

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