Our unique CDMO services

CDMO services
Small molecular manufacturing
・High Potency APIs ・Cryogenic & High Pressure reactions
・Continuous flow technology
・Process development & optimize

Oligonucleotide & Peptide synthesis
・Oligonucleotide （DNA / RNA / LNA etc.）
・PMO
・Peptide （Natural / Non-natural / liner / cyclic）

Large molecular manufacturing
・Unique microbial platform： CORYNEX®/ TALAMAX®
・ GMP production of Peptides, Proteins and Antibodies
・Propose the optimal total process for each customer's
drug development stage

High potency & ADC services
・Conjugation and Purification
・Process Development and Technology transfer

・Site-Specific Conjugation technology：AJICAP®

Drug product manufacturing
・Aseptic formulation

・Aseptic fill finish

・Vial, syringe, cartridge filling

・LNP

・Labeling & Packaging

Development & Scale up
・Process development
・Optimization & scale up for all manufacturing
capabilities

Product quality & Analytical services
・On-ｓite laboratories
・Phase appropriate analytical method development& lot release testing・ICH – ｃcompliant stability programs

MISSIONWE HELP TO IMPROVE THE HEALTH OF HUMANKIND.

TO BE A LEADING, TRUSTED, AND INNOVATIVEPARTNER TO OUR CUSTOMERS AND OUR EMPLOYEESVISIONOur global operationJapanBelgium•
Small molecule
manufacturing•
Continuous flow•
Highly Potent APIsUnited States• Large molecule expertise• Aseptic fill finish• High potency / ADCservices

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Oligonucleotide & Peptide synthesis
Small molecular manufacturing
AJIPHASE® Technology
CORYNEX® & TALAMAX®
AJICAP®
Central Aji Co. R&D for new technologies(Protein, ADC)

India
• Small molecule
manufacturing

Proteins / Antibodies
Secretion Production of Peptides/Proteins
by Endotoxin-free Microorganism 『CORYNEX®』
Value of CORYNEX
 Endotoxin-free, high-purity protein secretion platform・ Endotoxin-free C. glutamicum as host cell・ Purification process can be simplified
 Applicable for expression of various proteins・ Especially highly suitable for VHH, antibody mimetics and long peptides
E.coil (traditional system)CORYNEX(our system)

Innovative Antibody Production Technology
by Microorganism 『TALAMAX®』

TALAMAX®

Value of TALAMAX Antibody production with affordable cost

・ 1/10 the cost of raw materials for culture compared to animal cell culture
・ 1/2 the culture time compared to animal cell culture Suitable for antibodies for ADC and multi-specific antibodies
・ Aglycosylated antibodies, reducing the risk of side-effect caused by glycans
・ Having functions such as antigen binding and stability in blood
Comparison with a conventional commercial product (trastuzumab)
Impurity Levels
Impurity analysis a�er puriﬁca�on

Binding to antigen (hHer2)
ELISA

Stability in blood
Test of stability in blood

SDS-PAGE, non-reducing

One-Stop-Shop CDMO service
We create the most efficient total process by conducting everything from strain development tofermentation/purification processes and analytical system development at our own R&D site tobring your project to production.

ADC Technology
Site-Specific Conjugation and Linker Technologies
 No genetic engineering and no enzyme required ADCs with higher efficacy and lower toxicity achieved
 Applicable for any IgG molecule and a variety of payloads

Straightforward Site-SpecificConjugation Method

Applicable for Versatile ADCs

Higher efficacy and lower toxicity

Precisely controlled DAR

AJICAP® Site-Specific Conjugation
AJICAP® site-specific conjugation is an innovative direct chemical site -specific conjugation
method for intact native antibodies

Biological Activity of AJICAP®-ADCs
ADCs generated by AJICAP® site-specific conjugation and stable & hydrophilic linker has
higher efficacy and lower toxicity.

Large molecule manufacturing
As a leader in small molecule manufacturing, Ajinomoto Bio-Pharma Services has over 40
years of experience providing high quality APIs and intermediates for pharmaceuticalcompanies throughout the world.

□ Protein / Plasmid DNA□ Recombinant proteins / Fusion proteins□ Antibodies & ab fragments□ Enzymes□ Vaccines□ Gene therapy□ Microbial cell banking & characterization

Aseptic fill finish
delivers high quality sterile contract manufacturing and thorough inspection systems that are
customized to your manufacturing needs.

Conjugation
Liposomes
Nano-emulsions
Formation
Services

Emulsions
Nanoparticles
Conjugation of PEGs and peptides
LNP

Monoclonal
antibodies

Plasmid DNA

Small molecules

Recombinant
proteins

PeptidesOligonucleotides

Adjuvants

Vaccines

Suspensions

Labeling & Packaging□ Clinical & commercial packaging□ Clinical supplier storage□ High speed automated line

□ Track ＆ Trace

Small molecular manufacturing
Providing high quality APIs and intermediates,
High potency APIs

from lab scale through pilot to commercial

Cryogenic & high pressure reactions

production.

High energy chemistries
Expertise

Multipurpose production facilities

Biocatalysis
Continuous flow technology
Controlled substances （EU）

Robust development

Complex chemistries

Oligonucleotides / Peptides
Oligonucleotide manufacturing (by solid phase synthesis)
Offer variety of types oligonucleotides.
□ ASO□ siRNA□ CpG ODN

□ sgRNA, long chain RNA□ Aptamer□ miRNA mimic / inhibitor□ Decoy□ Conjugation with peptide / fluorescence□ Probes□ Enzymatic conjugation

APIfor clinical useIn vitro diagnostics
materials

Research Use

You can choose liquid synthesis manufacturing, AJIPHASE® .

Screening(ug)in vivo FS(- 100 mg )PRECLINICAL(- g)

PHASE I(- 200 g )PHASE II(- 200 g )PHASE III(- kg)

COMMERCIAL(- 20 kg)

Innovative liquid phase synthesis for oligonucleotide, peptide,

PMO and PPMOAJIPHASE®
AJIPHASE® is a hybrid of solid and solution phase syntheses that uses an anchor to make the molecules
very soluble in non-polar solvents, providing a homogenous mixture.
□ Mass production with High quality□ High reproductivity□ Seamless scale up from lab to commercial

Green Chemistry

FDA approval

Ajinomoto Bio-Pharma Services

Contact
Ajinomoto Bio-Pharma Services
GeneDesign, Inc.
〒567-0085 7-7-29 Saitoasagi Ibaragi, Osaka
TEL：+81-72-640+5180
E-mail：gdi_info@jp.ajibio-pharma.com

Notice;Our original technology

The specification and prices are subject to change
without notice.
As May 2023