Throughout all drug development stages, analytical development chemists work together with process chemists and engineers to assure that a precise and consistent know how is achieved at each step of the process. Taking into account the specific needs of each project and its respective development stage, methods are designed, tuned, and/or transferred in order to meet their purpose of use.
Our services and technical capabilities cover the needs for the development of robust API processes. This includes the use of High and Ultra Performance Liquid Chromatography coupled with a broad range of detectors like mass spectrometry, UV, DAD, IR, CAD and FLD detectors. Head Space Gas Chromatography is also readily available and coupled with mass spectrometry and FID detectors. Other complementary tests for impurity characterization, Genotoxic Impurities determination and solid state characterization (i.e. crystalline evaluation trough XRPD or DSC) are also part of the analytical portfolio.
Drug Product Development
The process for developing drug delivery systems involves the collaboration of various disciplines. At Hovione, working closely with the formulation scientists and being part of interdisciplinary projects teams, an experienced group of analytical chemists is dedicated to the analytical development support of drug product projects in all stages of development and production.
Reliable and reproducible analytical methods are important for pharmaceutical development process, drug product evaluation and stability. We have an extensive experience in method development and drug product systems characterization, covering a broad range of analytical techniques.
Our services include, among others, solid state characterization and systems physical stability evaluation, assay and related substances determination, particle size measurements and particle morphology studies, dissolution release testing of dosage forms as well as content uniformity and hardness/friability evaluation of formulations.
Inhalation Drug Products Testing
The delivery of drug products through the inhalation route has been increasing over the last decades. The in vitro testing of these products is crucial in order to determine their safety and efficacy.
Hovione has all the capabilities to perform in vitro testing of dry powder inhalers, from method development and optimization to transfer or validation. Equipped with temperature and humidity controlled rooms, analytical support can be given to projects on different stages.
In addition to chemical and physical characterization, QC and stability of inhalation drug products testing includes specific techniques such as delivered dose and Aerodynamic Particle Size Distribution (aPSD) by cascade impaction (using NGI and ACI). During method development the use of abbreviated cascade impaction equipment, such as the FSI, for fast screening of different formulations can also be performed.