Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced.
Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed.
Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies.
Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc.
During the development of orally and nasal inhaled (OINDP) drug products, it is important to fully understand the drug product characteristics and the drug device operation. Specialist testing capabilities and techniques such as laser particle sizing and aerodynamic particle size distribution (APSD) by impaction are necessary. OINDP experts also provide testing for spray pattern/plume geometry and delivered dose assessment.
Bringing quality and safety to life, CRO’s offer Total Quality Assurance expertise to help pharma companies to meet and exceed quality, safety and regulatory standards. We provide high quality Good Manufacturing Practice (GMP) compliant analytical services to the pharmaceutical, biotech and healthcare industries for inhalation and aerosol-based products as part of our comprehensive range of inhalation drug product development services.
Inhalation Product Analytical Testing includes Aerodynamic particle size distribution, Next Generation Impactor (NGI), Anderson Cascade Impactor (ACI), Abbreviated Impactor, Drug Delivery characterisation,Emitted and delivery dose uniformity, Total active substance delivery, Drug in small particles / droplets, Particle / Droplet Characterisation, Laser Diffraction (Malvern Spraytec), Morphology (Malvern Morphology G3), Plume geometry, Proveris Spray view, Spray Pattern, Method Development / Validation, Assay / Impurities / Moisture determination, Powder Rheology (Freeman FT4), Breath Simulating Pumps, Electronic Lung, Programmable Temperature / Humidity Controlled Laboratories etc.