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Peptide Synthesis and
Protein Engineering
Making peptide science work for you




 > GMP Manufacturing for Clinical Supply
 >
     complete first in man package
 > Chemokine Catalogue
 >
     Fluorescence Lifetime Assays
 > Proprietary best in class technologies
     for site specific protein modification
 > Preformulation Services, design and
     development capability for biologics




API Services &
Chemical Development
www.almacgroup.com
Peptide and Protein Precision Engineering
Commercial Services




                                        GMP Manufacturing for Clinical Supply
Clinical Technologies




                                        >   Expertise in chemical synthesis of long
                                            complex peptides
                                        >   cGMP manufacturing 2 - 200 amino
                                            acids, mg to kg scale
                                                                                          FLEXYTE:
                                        >   >150 man years experience
                                                                                          Fluorescence lifetime assays
                                                                                          >   Novel assay technology realizing the
                                        >   MHRA inspected and certified facility
                                                                                              benefits of fluorescence lifetime for drug
                                        >   High throughput non-GMP custom
Clinical Trial Supply




                                                                                              discovery applications
                                            synthesis supply
                                                                                          >   Reagents available in bulk and kit forms
                                        >   Customised products:
                                                                                              for Proteases and Ser/Thr Kinases
                                                 • Labelled or unlabelled
                                                                                          >   Custom assay development available for
                                                   (Biotin, AlexaFluor, Fluophores)
                                                                                              Tyr Kinases, Phosphatases, Lipid Kinases,
                                                 • PEGylated Peptides
                                                                                              Epigenetic targets
                                                 • Conjugated Peptides
Analytical Services




                                                                                          Proprietary best in class technologies
                                                                                          for site specific protein modification
                                                                                          >   Site specific C-terminal PEGylation of
                                                                                              recombinant proteins for enhanced
                                        Complete first in man package                         therapeutics.
                                        >   Chemical and analytical development           >   Chemical synthesis and site directed, site
Pharmaceutical Development




                                        >   Material supply for Tox and clinical trials       specific labelling of folded proteins up
                                        >   Oversight and management of                        to 200 amino acids
                                            formulation and sterile fill
                                        >   Oversight and management of tox trials
                                        >   Rabiolabelling
                                        >   Authorship of regulatory documentation
                                        >   Almac project management through to
                                            full IND package

                                        Chemokine Catalogue
API Services & Chemical Development




                                        >   Large range of catalogue chemokine
                                            products
                                        >   Labelled and unlabelled
                                            (Biotin AlexaFluor)
                                        >   Site specific labelling capability
                                                                                          Preformulation Services, design and
                                                                                          development capability for biologics
                                                                                          >   Peptide structural characterisation
                                                                                          >   Peptide chemical stability determination
                                                                                          >   Formulation development studies
                                                                                          >   Compatibility & stability studies
Biomarker Discovery & Development
www.almacgroup.com
Commercial Services




                                      Case Studies
Clinical Technologies




                                                                                                             Case Study 1
                                                                                                             Our client required a synthetic chemokine,
Clinical Trial Supply




                                                                                                             modified with unnatural amino acids and
                                                                                                             biotin labelled for clinical trial use.



                                                  >    Chemical process design and development in-house
Analytical Services




                                                  >    Natural and unnatural amino acids, biotinylated API
                                                  >    Complex folded chemokine, >70 amino acids in length
                                                  >    Analytical methods developed in-house
                                                  >    cGMP production of API
                                                  >    API Stability study
Pharmaceutical Development




                                                                                                             Case Study 2
                                                                                                             Our client required synthetic h-MDC,
                                                                                                             presented as a sterile filtered, lyophilised
                                                                                                             Drug Product in vials, for clinical trial use.



                                                  >    Chemical process design and development
API Services & Chemical Development




                                                       in-house
                                                  >    Analytical methods developed in-house
                                                  >    cGMP production of API
                                                  >    API and DP Stability study
                                                  >    Management of sterile vial filling of Drug
                                                       Product
Biomarker Discovery & Development




                                      For European Enquiries:           For American Enquiries:
                                      Almac                             Almac Group Incorporated
                                      Sciences                          25 Fretz Road
                                      Almac House                       Souderton, PA 18964
                                      20 Seagoe Industrial Estate,      United States of America
                                      Craigavon, BT63 5QD,              T +1 (215) 660 8500
                                      United Kingdom.                   E: sciences@almacgroup.com
                                      T: +44 (0) 28 3833 2200
                                      E: sciences@almacgroup.com
                                      www.almacgroup.com

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Peptide & Protein Capabilities

  • 1. Peptide Synthesis and Protein Engineering Making peptide science work for you > GMP Manufacturing for Clinical Supply > complete first in man package > Chemokine Catalogue > Fluorescence Lifetime Assays > Proprietary best in class technologies for site specific protein modification > Preformulation Services, design and development capability for biologics API Services & Chemical Development www.almacgroup.com
  • 2. Peptide and Protein Precision Engineering Commercial Services GMP Manufacturing for Clinical Supply Clinical Technologies > Expertise in chemical synthesis of long complex peptides > cGMP manufacturing 2 - 200 amino acids, mg to kg scale FLEXYTE: > >150 man years experience Fluorescence lifetime assays > Novel assay technology realizing the > MHRA inspected and certified facility benefits of fluorescence lifetime for drug > High throughput non-GMP custom Clinical Trial Supply discovery applications synthesis supply > Reagents available in bulk and kit forms > Customised products: for Proteases and Ser/Thr Kinases • Labelled or unlabelled > Custom assay development available for (Biotin, AlexaFluor, Fluophores) Tyr Kinases, Phosphatases, Lipid Kinases, • PEGylated Peptides Epigenetic targets • Conjugated Peptides Analytical Services Proprietary best in class technologies for site specific protein modification > Site specific C-terminal PEGylation of recombinant proteins for enhanced Complete first in man package therapeutics. > Chemical and analytical development > Chemical synthesis and site directed, site Pharmaceutical Development > Material supply for Tox and clinical trials specific labelling of folded proteins up > Oversight and management of to 200 amino acids formulation and sterile fill > Oversight and management of tox trials > Rabiolabelling > Authorship of regulatory documentation > Almac project management through to full IND package Chemokine Catalogue API Services & Chemical Development > Large range of catalogue chemokine products > Labelled and unlabelled (Biotin AlexaFluor) > Site specific labelling capability Preformulation Services, design and development capability for biologics > Peptide structural characterisation > Peptide chemical stability determination > Formulation development studies > Compatibility & stability studies Biomarker Discovery & Development
  • 3. www.almacgroup.com Commercial Services Case Studies Clinical Technologies Case Study 1 Our client required a synthetic chemokine, Clinical Trial Supply modified with unnatural amino acids and biotin labelled for clinical trial use. > Chemical process design and development in-house Analytical Services > Natural and unnatural amino acids, biotinylated API > Complex folded chemokine, >70 amino acids in length > Analytical methods developed in-house > cGMP production of API > API Stability study Pharmaceutical Development Case Study 2 Our client required synthetic h-MDC, presented as a sterile filtered, lyophilised Drug Product in vials, for clinical trial use. > Chemical process design and development API Services & Chemical Development in-house > Analytical methods developed in-house > cGMP production of API > API and DP Stability study > Management of sterile vial filling of Drug Product Biomarker Discovery & Development For European Enquiries: For American Enquiries: Almac Almac Group Incorporated Sciences 25 Fretz Road Almac House Souderton, PA 18964 20 Seagoe Industrial Estate, United States of America Craigavon, BT63 5QD, T +1 (215) 660 8500 United Kingdom. E: sciences@almacgroup.com T: +44 (0) 28 3833 2200 E: sciences@almacgroup.com www.almacgroup.com