1. Solid State Services
Supporting the development of APIs
from invention to launch
> Polymorph Studies
> Physical Form Screening & Selection
> Crystallisation Development
> Troubleshooting
> Physical Form Characterisation
> Analytical Method Development
& Validation
> Counterfeit Analysis
> Scientific Litigation &
Prosecution Support
> Inhalation Services
> Preformulation Support
API Services &
Chemical Development
www.almacgroup.com

2. Commercial Services
Solid State Services Scientific Litigation and
Prosecution Support
Supporting the development of APIs from invention to launch
Almac’s Physical Sciences Group has extensive experience of API development, our comprehensive range
Providing expertise in Pharmaceutical IP from expert witnessing to prosecution support
Clinical Technologies
of solid state services and know-how will help strengthen the success of your product. Our solid form
investigations are driven by science not robotics, with highly trained chemists and analysts directing the Almac has served the global pharmaceutical industry for over 30 years in discovery, process development,
studies. These scientists have the ability to solve virtually any problem presented to them. They know manufacturing, formulation and clinical services, offering the most comprehensive range of integrated drug
that finding and consistently producing the drug in its optimal physical form is vital to the success of development services. We can utilise over 300 highly skilled scientists who are organic chemists, solid state
your drug development programme. chemists, analysts, and formulation scientists, operating in state of the art facilities. Our expertise, built from a
Clinical Trial Supply
large volume of diverse projects, puts us in a unique position to provide expert witnessing services to pharma
litigation cases as a testifying or non-testifying witness. We provide services to both infringement and
Paragraph IV cases.
Polymorph Characterisation We provide technical expertise to assist in successful patent prosecution. This service includes technical
> Screening > Drug substance consultancy for IP and technical support for successful prosecution to overcome rejections and oppositions.
Analytical Services
> Selection > Drug product
> Stable form determination
Routine Analyses
Physical Form Screen & > Lot release
Selection > GMP compliant
Expert Witness Services IP Support Services
> Salt, cocrystal &
Pharmaceutical Development
amorphous screens Analytical Method Development Infringement support Intellectual Property Support
> Selection of optimum form & Validation > Laboratory testing of API & drug product > Technical consultancy
for development > Lot release & regulatory > API solid form analysis in the drug product > Laboratory testing to strengthen the patent
> Reproducible solid form compliance > Reverse engineering of drug products
of the API > Strategy development Patent Application & Prosecution
Counterfeit Analysis > Expert report > Prior art reproduction
Troubleshooting: > Impurity profile > Expert witnessing > Reproduction of specifications & examples
API Issues > API solid form analysis in the
> Crystallinity, solubility, stability, drug product Paragraph IV litigation support Patent Opposition Support
> Reverse engineering of > ANDA reproduction of API & drug product > Laboratory testing
API Services & Chemical Development
purification & yield
drug products > Laboratory testing of API & drug product > EPO hearing
> Batch to batch variation
> Scale up problems > Strategy development
Inhalation Services > Expert report
Drug Product Issues > Particle engineering > Expert witnessing
> Dissolution > Cocrystals
> Stability > Micronisation
> Amorphous content & control
Crystal Engineering > Moisture content &
> Crystal modification hygroscopicity
Crystallisation Development
> Process development, scale-up
Biomarker Discovery & Development

3. www.almacgroup.com
Commercial Services
Preformulation Services
Design and development capability for small molecules and biologics
Clinical Technologies
Our preformulation studies are designed to identify and select the optimal physical form of your
API. We know that by possessing a thorough understanding of the properties of your drug
substance, we can reduce the number of problems in development, lower development costs
and decrease development time.
Clinical Trial Supply
Determining & assessing the Peptide structural characterisation
solid state properties > LC-MS
> Crystallinity > Absorption & fluorescence
> Hygroscopicity spectroscopy
> Particle size, shape & > Circular dichroism spectroscopy
surface area > NMR
Analytical Services
> Moisture/solvent content
Peptide chemical stability
Solid state stability > Solution state chemical stability to
Solution state stability acid, base, oxidising media, light &
Plasma stability elevated temperatures
> Solid state chemical stability to
Biopharmaceutical profiling light, humidity & temperature
Pharmaceutical Development
> pH-solubility profile & pKa
determination
Formulation development studies
> Permeability & BCS classification
> Effect of pH
> Solubility in pharmaceutical
> Buffer concentration & buffer type
solvents
> Surfactants
> Solubility in physiological buffers
> Complexing agents
> Polymers & cosolvents
Animal formulation
development Compatibility & stability studies
> pH modifications > In a range of containers & closures;
API Services & Chemical Development
> Cosolvents assessed for peptide adsorption,
> Surfactants compatibility, glass leachates &
> Cyclodextrin inclusion complexes particulate formation.
> Lipid based formulations
Other parameters assessed:
Clinical formulation > Osmolarity
> Micronised powders/suspensions > Viscosity
> Solid/waxy dispersions > pH
> Lipid based formulations > Appearance
> Drug in capsule/bottle > Needle flowability
> Identification of impurities
during stress studies
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