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Plant Overview

• HQ R&D Bldg.

  • R&D and Analytical laboratories
  • Non-GMP manufacturing on small scale(Filter reactor size: Auto-synthesizer, 1L, 10L)
  • Max. Batch Size: ~20g (1L), ~200g (10L)*
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• Manufacturing Bldg. 1&2

  • cGMP manufacturing on middle to large scale(Filter reactor size: 30L, 300L)
  • Max. Batch Size: ~500g (30L), ~5kg (300L)*
  • SPPS, LPPS**, Micro-wave technology
  • One of the world’s largest down-stream facilities(φ450㎜ column, 500L lyophilization facility etc.)
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    Manufacturing Bldg. 1
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    Manufacturing Bldg. 2

*In case of Solid Phase Peptide Synthesis
** SPPS: Solid Phase Peptide Synthesis, LPPS: Liquid Phase Peptide Synthesis

Competitive Source of PeptiStar

Technology ~Synthesis (Microwave)~

Technology ~Synthesis (STag-PS™)~

STag ; Chemical Tag for Peptide Synthesis

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STag-PS ; Serial Peptides Synthesis system using Stag

Technology ~Novel LPPS~

LPPS using C-terminally Unprotected AAs

Ref.) Org. Lett. 2020, 22, 20, 8039-8043

https://doi.org/10.1021/acs.orglett.0c02984

WO2020/189621

BSA; N,O-bis(trimethylsilyl)acetamide

BSA; N,O-bis(trimethylsilyl)acetamide

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Features and Suitability of Synthesis Methods

	SPPS		LPPS
	Conventional SPPS	Microwave SPPS	Stag-PS	Unprotected LPPS
Features	-	Quick/Uniform heating	Serial coupling in CPME	Using Unprotected AAs
AA equivalent	2-6 eq.	1.5-3 eq.	1.2-2 eq.	1.1-1.5 eq.
AA unit cost	high	high	high	High - Low
Rxn. Time	Long	Short - Middle	Short - Middle	Short - Middle
Monitoring	Qualitative	Qualitative	Quantitative	Quantitative
Fragment Strategy	-	-	-	Possible
Filter Reactor	Necessary	Necessary	NOT necessary	NOT necessary
Scale up	Limited by facility scale PS：Max 300L	Limited by facility scale PS：Max 30L	Easy	Easy
Development time	Short	Short	Middle	Long
【Suitability to each scale】
Sample	★	★★★	☆	☆
Tox. study	★	★★★	★★	★★
Clinical Trial	★	★★	★★	★★
Commercial	★	★★	★★★	★★★

Confidential

Features and Suitability of Synthesis Methods

R&D Facilities

Headquarter R&D Building

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  Analytical laboratory (2F)
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  Synthetic laboratory (3F)

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  TOF-MS
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  Low Humidity Peptide Sampling Room
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  Lab Office.

GMP Manufacturing Facilities

Manufacturing Building 1

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  Purification Area (Class 100,000)

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  Reverse Osmosis Concentrator
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  Centrifuges
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  Synthetic Area

GMP Manufacturing Facilities

Manufacturing Building 2

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  Purification Area (Class 100,000)

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  Synthetic Area
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  Synthetic Area
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  Purification Area (Class 100,000)

Lyophilization Facilities

Purification Facilities

Summary

	Process Development	Manufacturing	QC/QA/Regulatory
PeptiStar Services	Process Development Scale up Analytical Method Development Validation	GMP/non-GMP manufacturing in any scale(Research to Commercial)	Various GMP test Stability Study Support for IND/NDA

Competitiveness in Cost and Quality,
achieved by Innovative Manufacturing