Kymos provides GMP-certified quality control for small molecule analytes such as raw materials, APIs, excipients, intermediates, IMPs, finished products, packaging materials, manufacturing equipment and process environment samples according to customer specifications or relevant pharmacopoeia (EP, USP, BP, JP). Non-compendial methods can also be transferred, validated or developed de novo, and for Quality Control purposes we work under approved Quality Agreements and issue GMP Certificates of Analysis (CoAs) signed by our QPs. These assays target manufacturers of drug substances and products in need of outsourcing specific techniques, non-routine tests as well as routine batch testing and release. Quality control involves multiple disciplines:

• General identification test (IR, TLC, HPLC)
• Appearance (colour, clarity)
• Assay (UV/Vis, AAS, titration, HPLC/UHPLC with multiple detectors, GC, GC/MS, LC/MS) and dosage uniformity
• Related substances identification and quantification (GC, HPLC, GC/MS, LC/MS)
• Physical determinations (pH, viscosity, density, polarimetry, refraction index, melting point, osmolality)
• Moisture (Karl Fisher, loss on drying)
• Limit tests (sulfated ash, wet-chemistry tests)
• Residual solvents (volatile organic compounds, organic volatile impurities)
• Impurities identification (HPLC/UHPLC, LC-MS, GC-MS)
• Impurities determination: degradation products, process and drug related impurities
• Elemental impurities (AAS, ICP/MS)
• Nitrosamine impurities (LC-MS-MS, HS-GC-MS)
• Solid oral dosage tests (disintegration, dissolution, hardness, friability)
• Particulate matter (visible and subvisible particles)
• Particle size distribution (Malvern Mastersizer 3000)
• Process environment analysis (cross-contamination, rinse water from cleaning process, swabbing surfaces)
• Analysis of Orally and Nasal Inhaled Drug Products (Andersen and New Generation Impactors)
• Extractables & Leachables
• In vitro release testing for semi-solids (vertical diffusion cells)
• Total Organic Carbon (TOC)
• Other CMC tests with specific departments

Kymos offers GMP-certified importation, batch testing and batch release services. We have several QPs and are certified importers and manufacturers for quality control of human, veterinary and investigational medicinal products (IMPs), with capabilities to test and release sterile, non-sterile products and high potency active ingredients (HAPI). Our integrated solution includes:

• Analytical method transfer (AMT)
• Batch testing according to the Certificate of Analysis
• Batch testing and batch release of clinical and marketing batches
• Full analysis of all parameters to issue a standalone batch Certificate of Analysis
• Individual parameter determination to be included in your batch Certificate of Analysis
• APIs Certificate of Analysis according to relevant pharmacopoeia
• Requesting Importation Authorization from the Medicines Agency
• Importation into the EU of drug products (human, veterinary or investigational)
• Warehousing, sampling, EU depot and shipment
• Storing retention or reference samples
• Issuing Qualified Person Declaration (annex 5.22)
• Auditing manufacturing plant in compliance with EU-GMP
• Managing quality agreement
• Reviewing transport conditions
• Managing out-of-specification, change control and incidents
• Batch manufacturing record review
• Batch release in accordance with Marketing Authorization