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Pg 1 cGMP PEPTIDE MANUFACTURE • Expertise in long, complex peptides, and peptide cocktails • Solid phase and liquid phase synthesis • Experience in conjugation to a wide range of chemical entities • Strong project management culture • Full support for CMC section preparation

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Page 1: cGMP PEPTIDE MANUFACTURE - Almac · cGMP PEPTIDE MANUFACTURE • Expertise in long, complex peptides, and peptide cocktails • Solid phase and liquid phase synthesis • Experience

Pg 1

cGMP PEPTIDE MANUFACTURE • Expertise in long, complex peptides, and peptide cocktails

• Solid phase and liquid phase synthesis

• Experience in conjugation to a wide range of chemical entities

• Strong project management culture

• Full support for CMC section preparation

Page 2: cGMP PEPTIDE MANUFACTURE - Almac · cGMP PEPTIDE MANUFACTURE • Expertise in long, complex peptides, and peptide cocktails • Solid phase and liquid phase synthesis • Experience

cGMP MANUFACTUREOF PEPTIDE

SERVICES & TECHNOLOGY PLATFORM

DEVELOPMENT AND MANUFACTURING CAPABILITIES• Experience-based process definition allows rapid development for early phase projects

• Integrated development team ensures smooth transition of projects from pre-clinical research to development

• Process validation roadmap to ensure Quality by Design for commercial products.

• Kg scale liquid phase capability ranging from 5L to 1000L

PURIFICATION AND ISOLATION• Biotage, preparative HPLC, SEC, and ion exchange purification expertise

• Proprietary purification methodology for long peptides

• Class 10,000 final product processing area

• Containment for purification and isolation of cytotoxics

ANALYTICAL SUPPORT• Analytical release testing• Full suite of ICH stability chambers• Drug Substance and Drug Product testing

www.almacgroup.com

GET IN TOUCH

UKAlmac Group(Global Headquarters)20 Seagoe Industrial EstateCraigavonBT63 5QDUnited Kingdom

[email protected]+44 28 3833 2200

USAlmac Group(US Headquarters)25 Fretz RoadSouderton, PA 18964United States of America

[email protected]+1 215 660 8500

All our clients have unique needs. That’s why we develop unique solutions. This is the

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