Our CMC Works withDNDi
October 22, 2021
Tomomi Kimura
Ajinomoto Bio-Pharma Services, GeneDesign
SALES&TECHNICAL SUPPORTAgenda1Introduction

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Works and Accomplishments with DNDi

1Agenda1Introduction

2

Works and Accomplishments with DNDi

2

Ajinomoto group Shared Value(ASV)ASV⇒ ASV means the Ajinomoto group creating Shared Value

Within the Ajinomoto group, our mission isü To contribute to the world’s food and wellness
ü To better lives for the futureWith the above concept,
we have been working on thisproject with DNDi
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Ajinomoto Bio-Pharma Services

SMALL MOLECULE
MANUFACTURING

LARGE MOLECULE
MANUFACTURING

OLIGO & PEPTIDESYNTHESISHIGH POTENCY& ADC SERVICESDEVELOPMENT &SCALE UP SERVICESDRUG PRODUCTFILL FINISHPRODUCT QUALITY &ANALYTICAL SERVICES

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Access to a Global Collective Service Offering

AjinomotoCo., Inc.
is actively
engaged in26 countries
and regions
worldwideBelgium•
Small molecule manufacturing•Chemistry expertise•Continuous flow•
Highly Potent APIs

United States•
Large molecule expertise•Aseptic fill finish•
High potency / ADC servicesJapan•
Oligonucleotide & Peptide
synthesis•
AJIPHASE® technology•Small molecule
manufacturing•
Central Aji Co. R&D for newtechnologies

India•
Small molecule
manufacturing

5Oligo CDMO Services Overview
SEAMLESS SUPPLY FROMRESEARCH TO COMMERICAL LAUNCH

Screening(ug)In vivo FS(～100mg)

PRECLINICAL(～g)

PHASE I(～200g)

PHASE II(～200g)

PHASE III(～kg)

COMMERCIAL(～10kg)Research-use
at small/ middle scale
GLP- use Manufacturing
GMP Manufacturing
DRUG
SUBSTANCE

Bridging to AJIPHASE®
Analytical Methods - Development, Stability & Release Testing, and Validation
Comparability Studies

DEVELOPMENT

Process Development / Scale Up / Optimization
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Brief Overview of Oligonucleotide Manufacturing
Synthesis

3’5’TCGA

SolidSupportCleavage &Deprotection
Purification
Desalting
Lyophilization
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Agenda1Introduction

2

Works and Accomplishments with DNDi

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Our History with DNDi
• Stag 1 and Stage 2 - Complete
For Launch• For launch, we will continue to prepare
2022~
2020~
2015~

Stage 1Stage 3Stage 2
ü Optimize manufacturing method
ü Monitore impurities through all manufacturing

ü Process R&D / Analytical development (CMC)ü 1st GMP Production
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Accomplishment of Stage 1

Stage 1

• Process R&D for D35
ü Synthesis conditions
ü Deprotection conditionü Purification Support & condition

Several hundred grams
GMP manufacturing

Synthesis

Cleavage &Deprotection

Purification

Desalting

Lyophilization
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Accomplishment of Stage 1

Stage 1

• Analytical Development for D35
ü Confirmation of Purity
ü Identification of Impuritiesü Confirmation of Sequenceü Stability Program / Degradation Tests

Method validation has
been done.
11Accomplishment of Stage 2

Stage 2

• Improved Process Successfullyü Scale up Synthesizerü Better Impurity Control
ü Turnaround Time for purification=one third.

With current Stage 2 process,several kg /year of API can be produced

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Next Stage Works for LaunchStage 3
Manufacturing

HigherProductivity

Confirm
Robustness

Ready forLaunchAnalysis

ChangeIncomplete
Test Methods

Validation

Ready forLaunchSupportNew-Drug
application
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Summary• Complete Stage 1 and Stage 2 with DNDi

Stage 3
Stage 2
Stage 1
Contribute to the world’s wellness
through works with DNDi
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LET’SMAKE
A NEW FUTURE

A Responsive, Trusted, Innovativeand Reliable Partner

Global Infrastructure for Adaptive
CDMO Solutions and Support

Dedicated to Your Clinical Studies
Through Commercial SuccessesYour Every Manufacturing
Challenge Embraced

WHAT DO YOU
WANT TO
MAKE?

15Thank You