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Peptide Synthesis and Protein Engineering - Almac

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<strong>Peptide</strong> <strong>Synthesis</strong> <strong>and</strong><br />

<strong>Protein</strong> <strong>Engineering</strong><br />

Making peptide science work for you<br />

> GMP Manufacturing for Clinical Supply<br />

><br />

complete first in man package<br />

> Chemokine Catalogue<br />

><br />

Fluorescence Lifetime Assays<br />

> Proprietary best in class technologies<br />

for site specific protein modification<br />

> Preformulation Services, design <strong>and</strong><br />

development capability for biologics<br />

API Services &<br />

Chemical Development<br />

www.almacgroup.com


Biomarker Discovery & Development API Services & Chemical Development Pharmaceutical Development Analytical Services Clinical Trial Supply Clinical Technologies Commercial Services<br />

<strong>Peptide</strong> <strong>and</strong> <strong>Protein</strong> Precision <strong>Engineering</strong><br />

GMP Manufacturing for Clinical Supply<br />

> Expertise in chemical synthesis of long<br />

complex peptides<br />

> cGMP manufacturing 2 - 200 amino<br />

acids, mg to kg scale<br />

> >150 man years experience<br />

> MHRA inspected <strong>and</strong> certified facility<br />

> High throughput non-GMP custom<br />

synthesis supply<br />

> Customised products:<br />

• Labelled or unlabelled<br />

(Biotin, AlexaFluor, Fluophores)<br />

• PEGylated <strong>Peptide</strong>s<br />

• Conjugated <strong>Peptide</strong>s<br />

Complete first in man package<br />

> Chemical <strong>and</strong> analytical development<br />

> Material supply for Tox <strong>and</strong> clinical trials<br />

> Oversight <strong>and</strong> management of<br />

formulation <strong>and</strong> sterile fill<br />

> Oversight <strong>and</strong> management of tox trials<br />

> Rabiolabelling<br />

> Authorship of regulatory documentation<br />

> <strong>Almac</strong> project management through to<br />

full IND package<br />

Chemokine Catalogue<br />

> Large range of catalogue chemokine<br />

products<br />

> Labelled <strong>and</strong> unlabelled<br />

(Biotin AlexaFluor)<br />

> Site specific labelling capability<br />

FLEXYTE:<br />

Fluorescence lifetime assays<br />

> Novel assay technology realizing the<br />

benefits of fluorescence lifetime for drug<br />

discovery applications<br />

> Reagents available in bulk <strong>and</strong> kit forms<br />

for Proteases <strong>and</strong> Ser/Thr Kinases<br />

> Custom assay development available for<br />

Tyr Kinases, Phosphatases, Lipid Kinases,<br />

Epigenetic targets<br />

Proprietary best in class technologies<br />

for site specific protein modification<br />

> Site specific C-terminal PEGylation of<br />

recombinant proteins for enhanced<br />

therapeutics.<br />

> Chemical synthesis <strong>and</strong> site directed, site<br />

specific labelling of folded proteins up<br />

to 200 amino acids<br />

Preformulation Services, design <strong>and</strong><br />

development capability for biologics<br />

> <strong>Peptide</strong> structural characterisation<br />

> <strong>Peptide</strong> chemical stability determination<br />

> Formulation development studies<br />

> Compatibility & stability studies


www.almacgroup.com<br />

Biomarker Discovery & Development API Services & Chemical Development Pharmaceutical Development Analytical Services Clinical Trial Supply Clinical Technologies Commercial Services<br />

Case Studies<br />

> Chemical process design <strong>and</strong> development in-house<br />

> Natural <strong>and</strong> unnatural amino acids, biotinylated API<br />

> Complex folded chemokine, >70 amino acids in length<br />

> Analytical methods developed in-house<br />

> cGMP production of API<br />

> API Stability study<br />

> Chemical process design <strong>and</strong> development<br />

in-house<br />

> Analytical methods developed in-house<br />

> cGMP production of API<br />

> API <strong>and</strong> DP Stability study<br />

> Management of sterile vial filling of Drug<br />

Product<br />

For European Enquiries:<br />

<strong>Almac</strong><br />

Sciences<br />

<strong>Almac</strong> House<br />

20 Seagoe Industrial Estate,<br />

Craigavon, BT63 5QD,<br />

United Kingdom.<br />

T: +44 (0) 28 3833 2200<br />

E: sciences@almacgroup.com<br />

www.almacgroup.com<br />

For American Enquiries:<br />

<strong>Almac</strong> Group Incorporated<br />

25 Fretz Road<br />

Souderton, PA 18964<br />

United States of America<br />

T +1 (215) 660 8500<br />

E: sciences@almacgroup.com<br />

Case Study 1<br />

Our client required a synthetic chemokine,<br />

modified with unnatural amino acids <strong>and</strong><br />

biotin labelled for clinical trial use.<br />

Case Study 2<br />

Our client required synthetic h-MDC,<br />

presented as a sterile filtered, lyophilised<br />

Drug Product in vials, for clinical trial use.

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