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Solid State ServicesSupporting the development of APIs from invention to launch
API Services &Chemical Developmentwww.almacgroup.com
> 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
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Almac has served the global pharmaceutical industry for over 30 years in discovery, process development, manufacturing, formulation and clinical services, offering the most comprehensive range of integrated drug development services. We can utilise over 300 highly skilled scientists who are organic chemists, solid state chemists, analysts, and formulation scientists, operating in state of the art facilities. Our expertise, built from a 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.
We provide technical expertise to assist in successful patent prosecution. This service includes technical consultancy for IP and technical support for successful prosecution to overcome rejections and oppositions.
Supporting the development of APIs from invention to launch
Almac’s Physical Sciences Group has extensive experience of API development, our comprehensive range 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 studies. These scientists have the ability to solve virtually any problem presented to them. They know that finding and consistently producing the drug in its optimal physical form is vital to the success of your drug development programme.
Solid State Services Scientific Litigation and Prosecution SupportProviding expertise in Pharmaceutical IP from expert witnessing to prosecution support
Expert Witness Services
Infringement support> Laboratory testing of API & drug product> API solid form analysis in the drug product> Reverse engineering of drug products> Strategy development> Expert report> Expert witnessing
Paragraph IV litigation support> ANDA reproduction of API & drug product> Laboratory testing of API & drug product> Strategy development> Expert report> Expert witnessing
IP Support Services
Intellectual Property Support > Technical consultancy> Laboratory testing to strengthen the patent
Patent Application & Prosecution> Prior art reproduction> Reproduction of specifications & examples
Patent Opposition Support> Laboratory testing> EPO hearing
Polymorph> Screening> Selection> Stable form determination
Physical Form Screen & Selection> Salt, cocrystal & amorphous screens> Selection of optimum form for development> Reproducible solid form of the API
Troubleshooting: API Issues > Crystallinity, solubility, stability, purification & yield> Batch to batch variation> Scale up problems
Drug Product Issues> Dissolution> Stability
Crystal Engineering> Crystal modification
Crystallisation Development> Process development, scale-up
Characterisation> Drug substance> Drug product
Routine Analyses> Lot release> GMP compliant
Analytical Method Development & Validation> Lot release & regulatory compliance
Counterfeit Analysis> Impurity profile> API solid form analysis in the drug product> Reverse engineering of drug products
Inhalation Services> Particle engineering> Cocrystals> Micronisation> Amorphous content & control> Moisture content & hygroscopicity
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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.
Preformulation ServicesDesign and development capability for small molecules and biologics
Determining & assessing the solid state properties> Crystallinity> Hygroscopicity> Particle size, shape & surface area> Moisture/solvent content Solid state stabilitySolution state stability Plasma stability Biopharmaceutical profiling> pH-solubility profile & pKa determination> Permeability & BCS classification > Solubility in pharmaceutical solvents> Solubility in physiological buffers
Animal formulation development> pH modifications> Cosolvents> Surfactants> Cyclodextrin inclusion complexes> Lipid based formulations
Clinical formulation> Micronised powders/suspensions> Solid/waxy dispersions> Lipid based formulations> Drug in capsule/bottle
Peptide structural characterisation> LC-MS> Absorption & fluorescence spectroscopy> Circular dichroism spectroscopy> NMR
Peptide chemical stability> Solution state chemical stability to acid, base, oxidising media, light & elevated temperatures> Solid state chemical stability to light, humidity & temperature
Formulation development studies> Effect of pH> Buffer concentration & buffer type> Surfactants> Complexing agents> Polymers & cosolvents
Compatibility & stability studies> In a range of containers & closures; assessed for peptide adsorption, compatibility, glass leachates & particulate formation.
Other parameters assessed:> Osmolarity > Viscosity> pH> Appearance> Needle flowability> Identification of impurities during stress studies
For European Enquiries:AlmacSciencesAlmac House20 Seagoe Industrial Estate, Craigavon, BT63 5QD, United Kingdom.T: +44 (0) 28 3833 2200E: [email protected]
For American Enquiries:Almac Group Incorporated25 Fretz RoadSouderton, PA 18964United States of AmericaT +1 (215) 660 8500 E: [email protected]
www.almacgroup.com
