Idealp Pharma Hits & Leads Optimisation Case Study 1
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