Analytical Capabilities
- 1. Analytical Services Meeting your analytical needs throughout drug development. > API and Drug Product Testing > Analytical Support for Clinical Trials > Comparator Testing > Physical and Chemical Characterisation > Method Development and Validation > ICH Stability Testing Analytical Services www.almacgroup.com
- 2. Commercial Services Analytical Services Clinical Technologies Meeting your analytical needs throughout drug development. From our state-of-the-art analytical laboratories, our highly skilled analysts deliver comprehensive analytical solutions to support your drug substance and drug product development programmes, as well as providing analytical and microbiological testing solutions for clinical and commercial drug product Clinical Trial Supply supply. Employing over 150 analysts at one site, we examine your drug substance and drug products chemical, physical and microbiological properties to support clinical manufacturing, commercial release, and stand-alone analytical projects. Analytical Services Product Testing > API Method Development & Validation > Assay Analytical Support to Clinical Trial Supplies > Drug product > Related substances Almac can provide the necessary on-site analytical support for all your clinical packaging projects and Pharmaceutical Development > Clinical trial material > Dissolution > Comparator > Cleaning verification beyond. Our dedicated analytical chemists provide information rich data on both comparator and > Stability indicating innovator material in full compliance with regulatory requirements. Comparator Testing > Bioanalysis > Method development and validation > Comparator dissolution Stability Testing > Stability API and Drug Product > Accelerated and long-term studies at all ICH conditions Capabilities: Physical Characterisation > Polymorph screening > Protocol and report preparation > Identification / Absence of active API Services & Chemical Development > Intrinsic dissolution > Elucidation of degradation pathways > Characterisation > Thermal properties > Identification of degradants > Release testing of IMPs > Particle morphology > Synthesis of degradants > Comparator studies > Method transfer Chemical Characterisation > Method development > Proof of structure > Method verification or validation > Identification of impurities > Stability testing > Identification of degradants > Re-assay > Identification of metabolites Biomarker Discovery & Development Our method development team routinely work with challenging drug molecules in order to establish fit-for-purpose methods utilising cutting edge technology. This enables our customers to benefit from having the right data, at the right time, to the highest standards. Almac’s highly experienced stability testing group provides a turn-key service encompassing protocol writing, sample labelling and storage, study management, analytical testing and report writing. Unique to Almac is the ability to identify, isolate and synthesize degradation products that may form on storage.
- 3. www.almacgroup.com Commercial Services Comparator Studies Comparator activities Active and Placebo activities Clinical Technologies > Develop and validate analytical methods > Cleaning analytical method verification > Structure elucidation of organic > Validation / transfer of drug product impurities analytical methods > Over-encapsulated comparator stability > Manufacture technical batch of customers’ profile active tablet formulation Clinical Trial Supply > Manufacture and release of GMP > Manufacture and release clinical batch of batches of over-encapsulated comparator customers’ active tablet formulation > Manufacture and release of placebo tablets > Manufacture and release of over-encapsulated active tablets > ICH stability Analytical Services Comparator Products Pharmaceutical Development > Penicillin VK > Hydroxychlorquine Sulphate > Formoterol > Morphine Sulphate ER > Levofloxacin > Aspirin > Morphine Sulphate IR > Carbamaxepine > Omeprazole > Oxycodone > Trimethobenzamide > Minocyline > Simvastatin > Telithromycin > Isosorbide-5-mononitrate > Pravastatin > Zolpidem Tartrate > Atorvastatin > Glipizide > Warfarin Sodium > Budesonide API Services & Chemical Development Equipment Capabilities > HPLC > LC-MSn > NMR > Microscopy > UPLC > GC-MS > FTIR > Particle Sizing > Ion Chromatography > MALDI-TOF > UV > DSC > GC > Polarimetry > TGA Biomarker Discovery & Development > GC-HS > DVS > Dissolution For European Enquiries: For American Enquiries: Almac Almac Group Incorporated Almac House 25 Fretz Road 20 Seagoe Industrial Estate, Souderton, PA 18964 Craigavon, BT63 5QD, United States of America United Kingdom. T +1 (215) 660 8500 T: +44 (0) 28 3833 2200 E: sciences@almacgroup.com E: sciences@almacgroup.com www.almacgroup.com