23
1 MaRS | May 15, 2009 Thomas G. Wellner – President & CEO Dr. David N. Bell – VP Drug Development & CSO www.therapurebio.com

Overcoming process development and biologics manufacturing challenges

Embed Size (px)

DESCRIPTION

Speakers: Tom Wellner and David Bell from Therapure Biopharma Part of the Drug Development Discussion Group Event Series at MaRS. For more information, please visit: http://www.marsdd.com/Events/Event-Calendar/Drug-Development-Discussion-Group/therapure-05152009.html

Citation preview

Page 1: Overcoming process development and biologics manufacturing challenges

1

MaRS | May 15, 2009Thomas G. Wellner – President & CEO

Dr. David N. Bell – VP Drug Development & CSOwww.therapurebio.com

Page 2: Overcoming process development and biologics manufacturing challenges

2

13/ of all newproducts

The future of medicine

2

Page 3: Overcoming process development and biologics manufacturing challenges

3

$51B

$87B

$25B

$89B

2001

Protein therapeutic market

2005 2010 2010

Worldwide mobile technology market

Page 4: Overcoming process development and biologics manufacturing challenges

4

You discovered a protein with blockbuster potential

Specific

Safe

Targeted

Efficacious

Novel

4

Page 5: Overcoming process development and biologics manufacturing challenges

5

Ultimately, to get your product approved you will invest…

You are working hard to develop it

5

11 years 5 clinical

trials 2,000

patients 39 patents ~$1 billion

Page 6: Overcoming process development and biologics manufacturing challenges

66

What about manufacturing?

What about manufacturing?

Page 7: Overcoming process development and biologics manufacturing challenges

7

Discovery Development

Marketing Manufacturing 7

Page 8: Overcoming process development and biologics manufacturing challenges

8

Scaling up is not easy

Simple

Quick

Inexpensive

Milligrams

commercialbench

Complex

Long lead times - 4-5 years

Expensive -

$150+ million

Kilograms8

Page 9: Overcoming process development and biologics manufacturing challenges

9

Therapure Biopharma:Overcoming the manufacturing barrier

Complex We know protein purification

Long lead times Ready to go now

Quality cGMP compliant

Expensive Established Meadowpine Facility

Regulated We have 8 INDs under our belts

9

Page 10: Overcoming process development and biologics manufacturing challenges

10

Committed to the development, manufacture, purification, and packaging of high-quality biological therapeutics

10

Therapure Biopharma Inc.

• Flexible, modern cGMP manufacturing facility

• Expertise in manufacturing & downstream purification

• Extensive quality systems• Deep understanding of

advanced biology & complex proteins

• Creative partnering options

Page 11: Overcoming process development and biologics manufacturing challenges

11

Therapure Biopharma – Key Facts

Company Established

• Assets of former Hemosol business acquired Q3/2007 including modern and flexible Health Canada approved facility

• Therapure Biopharma Inc. launched Q3/2008

Ownership Financing

• Privately held by Catalyst Fund Limited Partnership II, a Canadian based private equity fund, and management

Page 12: Overcoming process development and biologics manufacturing challenges

12

Modern and Flexible Facility

Facility Built: 2003

Size: 130,000 ft2 (12,000 m2)

Location: Toronto, Canada (Mississauga)

Minutes from Toronto’s Lester B.Pearson International Airport

Employees: 65

Capabilities

• Development, manufacture and fill/finish of therapeutic proteins

• Product development

• Process development

• Manufacturing

• Fill/finish

• Lyophilization

Designed to meet U.S. FDA, Health Canada and EMEA requirements

Page 13: Overcoming process development and biologics manufacturing challenges

13

Our Business Strategy

CornerstoneCDMO Business

Unique & Flexible Facility

Scientific & Biomanufacturing

Expertise

Creative Financing

Develop Products-TBI Pipeline

-Joint Venture

Page 14: Overcoming process development and biologics manufacturing challenges

14

Key Milestones

Therapure Biopharma Inc. established July/08

Manufacturing plant re-validated Sept/08

Key talent retained and hired

Plant upgraded to create flexible multi-use facility Dec/08

Several key partner/client agreements executed

Revenue generation in 2008

Break even goal in 2009

Business development activities increasing

Pipeline milestones achieved for core assets

Health Canada re-certification of plant – May/09

Page 15: Overcoming process development and biologics manufacturing challenges

15

Key Clients / Global Collaborations

Client project opportunities continue to grow

Rare protein development project Growth factors for stimulating bone regeneration

Iron Chelating Agent for thalassemia

PEGylated biologic oncology product

Page 16: Overcoming process development and biologics manufacturing challenges

1616

Experienced Sr. Management Team

• Thomas Wellner President and CEOEli Lilly & Co.

• Dirk Alkema, Ph.D.Vice President, OperationsConnaught Labs and Hemosol

• Peter Winkley, CA Vice President Finance and CFOMDS and Ernst & Young

• David Bell, Ph.D. Vice President, Drug Development and CSOBioChem Therapeutic Inc and FAA

Page 17: Overcoming process development and biologics manufacturing challenges

1717

Sophisticated Biologic Development &Manufacturing Services

Sophisticated Biologic Development &Manufacturing Services

Page 18: Overcoming process development and biologics manufacturing challenges

18

Integrated Full Service Provider

• “One stop-shop” for development and manufacture of therapeutic proteins

• Cost-effectively manage all aspects of development and manufacturing at both small (mg) and large (kg) scale:– Upstream processing– Downstream processing– Clinical supplies including distribution– Commercial manufacturing– Fill and finish– Lyophilization– Full analytical support

Page 19: Overcoming process development and biologics manufacturing challenges

19

Fully Integrated Services

Upstream Processing Molecular biology Cell line creation &banking Mammalian cell culturesDownstream Processing• Protein modification• Purification• Stabilization

mg to kg scale batches Preclinical scale Clinical scale Commercial scale

• Aseptic filling of glass vials & preformed bags• Lyophilization• Clinical supplies including distribution

CommercialProduct

Page 20: Overcoming process development and biologics manufacturing challenges

20

High Quality Manufacturing Facility

Chromatography Analytical Laboratory

Vial filling line Buffer farm

Page 21: Overcoming process development and biologics manufacturing challenges

2121

Support Beyond Development & Manufacturing

Page 22: Overcoming process development and biologics manufacturing challenges

22

Creative Financing Opportunities

Therapure can potentially offer creative financing to partners who require development and biomanufacturing services:

Secured DebtEquity partnershipJoint Venture

Page 23: Overcoming process development and biologics manufacturing challenges

23

Your trusted partner for protein development & manufacturing

Your trusted partner for protein development & manufacturing

23www.therapurebio.com