YMC Group’s Network

From Laboratory To Plant-Scale Separation/Purification

Through YMC Group’s offices and sites in Japan and overseas, we secure our global supply chain and customer service. Ourpurification service will be soon available not only in Japan but also in Europe, the U.S. and India.
We are also planning to increase our offices mainly in countries and regions where the pharmaceutical business is expected to grow.

YMC Europe GmbHYMC Korea Co., Ltd.

Custom Purification And
Separation/Purification Technologies

YMC America, Inc.

YMC CO., LTD.

YMC India Pvt. Ltd.

YMC Singapore

YMC Taiwan Co., Ltd.

YMC Shanghai Rep. Office

Tradelinks Pte. Ltd.

InquiriesH

http://www.ymc.co.jp

PB-0064E

We now offer a complete GMP conforming
custom purification service
At YMC we have developed high performance packing materials, packed
columns, and separation system applicable to a range of scales fromO

Advantages ofCustom Purification
Separation and purification using chromatography may require
high technology, time and cost.
At YMC, we provide purification services with our accumulated
experiences, know-how, and excellent equipment.
Not only ensuring purification of a target substance according
to your request, we will also propose an efficient separation
method that may result in a cost reduction, based on our pastachievements and know-how.

microanalysis to large-scale isolation since our foundation in 1980.
Our advanced chromatography technology is evaluated and recognized as
the global leading brand particularly in the field of pharmaceuticalindustry.

ORequestor*■ Difficult purification method setting■ Expensive purification columns and packing
materials■ Lack of separation/purification devices/facilities■ Lack of time and human resources

Following the recent addition of a portfolio of bio-processing products
useful for purifying biotechnology-based drugs based on our richexperiences and achievements over the years, we have commenced
supply of products for chiral technology.
Furthermore, we are constructing a pharmaceutical-grade purification
plant to allow YMC to offer a complete custom purification service forhighly value-added substances including biotechnology-based drugs.

CH 3O*OH

Use of a service provided by YMC

Steps for Using aPurification ServiceWe respond flexibly to your needs including
confidentiality, GMP requirements, and budget at an initialmeeting.
Please feel free to consult with us to process large or small
amounts of materials.

Purification request• Meeting of the both parties• Signing a non-disclosure agreement• Consideration of preparatory conditions basedon a submitted sample

Report for preparatory considerations• Proposal of an optimal column and a mostefficient separation method and approval

Submission of an estimate■ Accumulated achievements and know-how of
separation/purification■ Low-cost columns and packing materials manufacturedin-house■ Availability of large columns and separation devices

Main purification• Separation/purification with an optimal method

Delivery of a purified substanceand submission of a report
Supply of high-purity
chemical compound

API purification plant
will be completed.

Quick service
High credibility
Low cost(To start operationin September 2015)

Purified preparation
A biotechnology-based drug API for a clinical trial
Chiral compound
Oligonucleotide
Achiral compound
Peptide/protein
Active pharmaceutical ingredient (API)Impurities, etc.

Our Production Facilities Include
the World’s Largest Chromatographic Systems and Columns
Komatsu Works (Ishikawa Prefecture) offers apurification service from several tens of grams
to several tons
Komatsu Works is our R&D and manufacturing site for HPLC
columns and packing materials, and all of these products
are shipped from here to our customers in Japan andabroad. The custom purification service has been provided
by installing large separators and large dynamic axial
compression columns in our explosion-proof purification
plant (FX Plant). Our new pharmaceutical-grade purification
plant will open in September 2015.

1

We have large dynamic axial compression
columns in a range of sizes, including one
with an internal diameter of 1,000 mm, as
well as systems of appropriate sizes, large
concentrator, freeze-dryer, etc. The column
with the internal diameter of 1,000 mm canbe loaded with several hundred grams at atime, while being suitable for plant-scale
purification of several tons.

2

Separation Technology
We develop, manufacture, and sell separation systems suitable for laboratory- to plant-scale,with the experience of using them in our in-house custom purification services.
We choose the optimal device for each separation/purification project, depending on thetarget substance, purity and scale required from the wide range of techniques available,

Standard flow rate and load according to internal diameters of columns
Internal diameter ofa column (mml. D.)

4.6

1020

50

100

200

500

1000

Cross-sectional ratio

1.0

4.7

19118

473

1,890

11,80047,300

0.5

2.4

9.5

60

235

950（6 L）

1.0

4.7

19120

470

1,900（12 L）

525

100

600

2,500

10,000（60 g）

Flow rate (mL/min)ranging from a bioprocessing system to a recycling system, an SFC system, and an SMB
system, in addition to an explosion-proof system.

Load (mg)

6,000

12,00060,00024,000（24 L）

47,000（47 L）

240,000（240 g）

Bioprocessing Systems and Columns

HPLC Systems and Dynamic Axial Compression Columns

Optimal for chromatographic purification for manufacturing
a biotechnology-based drug

Optimal for purification of low molecular compounds,
peptides and chiral compounds■ Separator BioStream■ K-Prep systems• Completely manufactured in Japanand suitable for cGMP

• Processes volumes from lab- to plant-scale• Sanitary design for ease of cleaning• Maximum flow rate: Up to 25 L/min• Maximum flow rate: up to 30 L/min• Compatible with GMP/explosion-proof operation• Fully automated operation via PC is possible• Can be customized to your needs■ YMC Pilot Columns• All the wetted parts are madeof non-metalic materials• Easy adjustable plunger height• Wide range of internal diameters,e.g. 100, 140, 200 mm, etc.
• Many options are also available■ Axial compression columns DAD/DAU• Axial compression columns pack automatically• Superior column performance,endurance and reproducibility achievedby constant pressurization• Internal diameters from 50 to 1,000 mm• Compatible with GMP/explosion-proofopearation

34

Particle Technology

GMP Support

High Performance Packing Materials to Achieve Highly Efficient,
Low Cost Purification

In the Komatsu Works, our Quality Assurance and Quality Control Units established a GMP organization independent from our
Manufacturing Control Unit. Under our strict quality control system, we can purify a large volume of an active pharmaceutical ingredient
for a clinical trial by using our large scale facilities that can be validated.

GMP OrganizationBecause all of YMC’s packing materials go through thorough quality control
and are identified with minimal lot variations, they are highly evaluatedand used by customers across many industries including drugs, foods andchemistry in Japan and other countries. Our packing materials areregistered on DMF (Drug Master File) for proven safety.
We offer a broad portfolio of high performance packing materials made ofsilica gel, polymer-based ion exchange media, and organic hybrid silica, as
well as one for chiral separation. We propose optimal separation conditions
using those packing materials for our custom purification service, for highly
efficient, low cost processing.

Manufacturing
Supervisor
Quality Assurance Unit
Quality Assurance Manager
Quality Assurance Sub-manager

Ion Exchange Media BioPro and BioPro SmartSep-Optimal for separation of proteins and nucleic acids for biotechnology-based drugsComparison of dynamic binding capacity (DBC)
120

DBC (mg/mL gel)

BioPro and BioPro SmartSep are ion exchange media used for initial(capture) to final purification (polishing), based on hydrophilic polymerswith minimal non-specific adsorption and strong/weak ion-exchange
matrices. With high dynamic binding capacity (DBC) and high recovery forproteins, they allow rapid processing of large volumes, which demonstrates
the high productivity in purification of many types of proteins and nucleic
acids used for biotechnology-based drugs.

Quality Control Manager
Quality Control Sub-manager

Manufacturing Control Manager
Manufacturing Control Sub-manager

Competitor A Type S 30 µm

80Competitor B Type S 30 µm

6040

Out Network in Japan200

Human polyclonal IgG(MW : 150,000)-Excellent stabilityComparison of alkaline stability(pH 11.5 and 50℃)120% of initial theoreticalplate number

Manufacturing Control Unit

BioPro SmartSep S30

100

Organic Hybrid Silica Packing Material YMC-Triart Prep
YMC-Triart Prep is the bulk packing material for HPLC purifications basedon organic hybrid silica. This highly stable product can be washed withalkaline solution. It also has a high mechanical strength so its particles canbe subjected to repeat repacking.
With its high chemical and mechanical stability, YMC-Triart Prep can beused repeatedly over a long period, resulting in high cost-efficiency.

Quality Control Unit

Triart Prep C18-S10080• Head Office (Kyoto Prefecture)• Chiral Technologies Laboratory (Kyoto Prefecture)• Scientific Instruments Division (Kyoto Prefecture)• Komatsu Works (Ishikawa Prefecture)• Tokyo Sales Office (Tokyo Prefecture)■ YMC Engineering CO., LTD. (Kyoto Prefecture)■ YMC Technos CO., LTD. (Tokyo Prefecture)

Conventional silica
based C1860■ YMC CO., LTD.

Facility for purifying from several tens of grams
to several tons
Komatsu Works (Ishikawa Prefecture)

Head Office

40

Tokyo Sales Office2000100200

Time (hr)300

Chiral Separations - CHIRAL ART

YMC Technos CO., LTD.

-Polysaccharide derivative functionalized packing materials to reduce chiral purification costScientific Instruments Division

CHIRAL ART is a range of packing materials for isolating optical isomers using a polysaccharide derivatives as chiral selectors. Due totheir high steric recognition ability, they allow separation of a broad range of chiral compounds. They are also useful for isolating
cis-trans isomers and position isomers. With their high cost-effectiveness, they can be used for a variety of purposes.

5Systems and columns manufacturing facility
YMC Engineering CO., LTD. (Kyoto Prefecture)

Facility for purifying from several milligrams toseveral tens of grams
Chiral Technologies Laboratory (Kyoto Prefecture)6