Helping our clients achieve Total Quality Assurance through custom and flexible contract services, we provide regulatory-driven, phase-appropriate laboratory services in support of CMC programs for both small molecules and biologics from our GLP/GCP/GMP laboratories. Services include method development and validation, analysis, stability studies, extractables and leachables, cGMP quality control testing, cGMP batch release testing and formulation development. Our teams have specialist drug development experience for complex medicines such as biologic therapeutics or vaccines and drug delivery systems such as inhaled or nasal drug products.

We have in-depth biopharma analytical experience; our experts strategically deploy orthogonal approaches in line with ICH Q6B that address key molecular and biological characteristics relevant to ensuring the safety and efficacy of your specific product. This includes total protein quantity, structure (including higher-order structure), biophysical behaviours (e.g. assessment of aggregation), physicochemical properties, assessment of heterogeneity within a sample and across batches and the intricacies of the biomolecule structure including PTMs.

With integrated formulation and stability teams, we can conduct forced degradation studies, determine what effect formulations have on the higher-order structure and use stability data to provide the next level of support if stability issues are observed.

Over the last 30 years, we have helped some of the largest and most innovative pharmaceutical companies navigate the challenges of drug development. Our scientists at our newly expanded European Centres of Excellence are ready to work with you now to enable and accelerate your product development.

Please contact our team to learn how our 30+ year experience can accelerate your drug development:
E: [email protected]
T: +44 (0)1763 261 648
www.intertek.com/pharmaceutical
www.intertek.com/pharmaceutical/analysis/inhalation-product-development/
www.intertek.com/pharmaceutical/biopharmaceuticals/
Video: https://youtu.be/XNRFUlrZcVQ