refreshingly adaptable cdmo...refreshingly adaptable cdmo cphi worldwide pharma insight briefings a...

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Refreshingly Adaptable CDMO

CPHI Worldwide Pharma Insight Briefings

A CDMO’s Perspective: Our Role in Today’s Supply Chain

Marc Sauer – VP Research and Development&

Matt Frizzle, Director Business Development

October 26th 2017

CPHI Pharma Insight Briefings: CDMO Perspective – Our role in Today’s Supply Chain 2

Contents

CDMO Market Overview

Recent Trends and Opportunities

BioVectra’s Approach to succeed within today’s supply chain

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About BioVectra

Globally operating North-American CDMO

4 cGMP Facilities (110,000 Sq. Ft.) in Atlantic

Canada

50 m3 chemical and 70 m3 fermentation reactor

space

45 years experience

300 Employees

Commercial filings (ANDA, DMF, VMF, CMC)

FDA, Health Canada, Japanese PMDA Inspected

Development to commercial manufacturing services:

Complex Chemistry

Microbial Fermentation

Formulation Development

CPHI Pharma Insight Briefings: CDMO Perspective – Our role in Today’s Supply Chain

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Global Trends – Pharmaceutical Market 1


1) Pharma Strategy DCAT Presentation – Graham Lewis IMS Health

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Trends in CDMO Market 2,3


2) Pharmaq&BioTech 2017 Review outsourced manufacturing, Results Healthcare3) Pharmoutsourcing featured article, Changes in the wind for CDMO market – That’s Nice

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What is being outsourced 4,5


4) Pharma Outsourcing DCAT Presentation – Jim Miller Pharmasource5) CMO/CDMO Market Outlook 2016 - American Pharmaceutical Review, That’s Nice

• Each project is unique

Increasing need for specialized technologies and skill sets

Custom, tailored process development, scale-up and validation plans

• Pricing pressures to reduce healthcare costs continue to mount

Simplified Supply chain - need for end-to-end service provider, but not necessarily one stop shop

CDMO/client proximity becoming increasingly important

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Current Trends from a CDMO Point of View


• The amount of time allocated for development is becoming less and less

Increasing amount of fast track and breakthrough designations

Programs need to be ready to be “locked in” at earlier stages of clinical development

Speed and the ability to respond to scope changes

• Importance of customer service

Personalized and dedicated project management, access to CMO’s subject matter experts

Customized SOP’s and flexible document system allowing for client input

Approach each project with flexibility and adaptability, phase appropriate development and manufacturing

Being a partner in our client’s success rather than a service provider

Willingness to grow with the client, dedicated facilities, risk-sharing

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Current Trends from a CDMO Point of View


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Supply Chain Opportunities from a CDMO Point of View


6) 2017 Nice insight CDMO Survey - That’s Nice

Access to specialized technologies 6

Improved QualityExpertise

Customer ServiceCost Reduction

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Where to go from here?


• Small Molecules• Proven Technologies• Service Provider

• Large Molecules• Adjacent Capabilities• Partnership

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About BioVectra

Development to commercial manufacturing services:

Complex Chemistry

Microbial Fermentation



CONFIDENTIAL12

Fermentation: Large Molecule

MPEG Reagents

Chemical Synthesis

Fermentation: Small Molecule


Bio-Reagents

HighPotency

Complementary Niche Capabilities

Capabilities Presentation 13

• Phase Appropriate Development

• Chemical Synthesis Labs

Glassware to 50 L

Biotage Units: Isolera One, Isolera LS

400 MHz NMR Spectrometer

• Fermentation Labs

4 x 1.5 L, 15 L, 2 x 20 L Bioreactors

AKTA Purification Systems

Shaker/Incubator, Centrifuge

• Potent compound handling

• Analytical Method Development & Validation

HPLC, UPLC, GC, SEC, IC, XRD

CAD, UV, ELSD, RI, FID; MS; MS/MS

Process Development


Small Molecule Chemical Synthesis

• Complex Chemical Synthesis

• 6 GMP Reactor Suites

50 L, 2x100 L, 200 L, 800 L

2 x 4,000 L

-60 oC to 140 oC

• Hydrogenations

• Potent compounds

• Class 100,000 Capabilities

• Non GMP Reactors

200 L, 2 x 400 L, 800 L

2 x 2,000 L, 3,000 L, 4,000 L

-25 oC to 120 oC


Small Molecule Fermentation

• Small Molecules

• Potent Compounds

• Pilot Suite

130 L

1,500 L

• Commercial Suite

30 L

500 L, 1,000 L

10,000 L, 15,000 L

• Chromatography

Normal Phase

Reverse Phase

Ion Exchange

Hydrophobic Interaction


Large Molecule Fermentation

• Large Molecules

• Peptides, Proteins/Enzymes, Antibodies

• Pilot Suite

200 L

• Expansion Suite

100 L

3,000 L

2 x 17,000 L

• Purification & Isolation

Ultrafiltration

Diafiltration

Wiped film evaporation

Lyophilization


• Complex delivery systems

Liposomes

Polymer based formulations

Nanoparticles

MPEG Chemistry & conjugation

• Potent compounds

• Prodrugs

• Depot formulations

• Process development & optimization

• Manufacturing technologies

Microfluidization

Extrusion

Homogenization

Wet, Dry Milling

Formulation Development and R&D


MPEG Reagents

• Public domain derivatives

Maleimides

Aldehydes

NHS Esters

Activated carbonates

• Custom MPEG derivatives

• Secure MPEG raw material source

• Proprietary purification technology

Low diol (<1%)

Low polydispersity (1.01)

• Phase II to Commercial supply

• 1 – 30 Kg manufacturing scale

CONFIDENTIAL 19


MPEG Reagents

Chemical Synthesis



Bio-Reagents

HighPotency

Complementary Niche Capabilities

CONFIDENTIAL


MPEG Reagents

Chemical Synthesis



Bio-Reagents

HighPotency

Chemical Modification of

Fermented Metabolites

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HighPotency

Combination Technology Products

CONFIDENTIAL

PEGylation of Fermented

Large Molecules

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MPEG Reagents

Chemical Synthesis



Bio-Reagents

HighPotency


CONFIDENTIAL

Formulation of Small

Molecules

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MPEG Reagents

Chemical Synthesis



Bio-Reagents

HighPotency


CONFIDENTIAL

Chemoenzymatic Synthesis

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MPEG Reagents

Chemical Synthesis



Bio-Reagents

HighPotency


CONFIDENTIAL 24Capabilities Presentation

Quality One quality system applied to four facilities across North

America History with global regulatory agencies

ExpertiseComplex chemistry, high potent APIs, microbial fermentation, and MPEG Reagents/Conjugation

AdaptableFlexible and scalable capacity aligned to the needs of our

customers

Experience 45 years of custom manufacturing >10 commercial filings

over 10 years

PartnershipsDedicated product operations, co-development programs,

and program specific capacity expansions

Refreshingly Customer-Focused Offering

refreshingly adaptable cdmo...refreshingly adaptable cdmo cphi worldwide pharma insight briefings a...

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