Areas of Expertise
Hovione has the experience and capabilities to perform analytical development work in various areas, namely, API production, drug product development work and inhalation drug product testing.
For that purpose, Hovione analytical chemists have expertise in:
- Solid and particle characterization
- Wet analysis
How we make a difference:
- Dedicated analytical chemists assigned to each project from inception to validation stage ensure that all the information collected throughout the phases of development is not lost and is used to build process knowledge
- State of the art analytical equipment allows the development of the methods that most adequately fit the chemist´s requirements. Capacity to handle potent products and/or with special handling requirements (hygroscopic, light sensitive, etc).
- LIMS software manages all analytical data, including the generation of CofAs. A customized information system platform allows the customer to remotely see in real time the analytical results obtained during in process control and release testing.
- Several years of experience in analytical chemistry enable Hovione teams to provide troubleshooting solutions and propose alternative techniques to enhance response times and productivity.
Solid State and Particle characterization
Solid State characterization is fundamental for the pharmaceutical industry. The majority of pharmaceutical compounds are produced as solid materials and their ability to exist in different solid forms, crystalline and amorphous, allows them to exhibit different physical properties. This has a direct impact on bioavailability and bioequivalence as well as on drug product manufacturing process and stability. As a result, control of the solid-state behavior of the drug is important during its whole life cycle.
Particle characterization is also crucial throughout the entire drug development and commercial stage due to the fact that size and morphology can influence product performance, processability and drug bulk properties.
At Hovione, comprehensive development studies, solid state and particle size methods development, as well as a complex solid state system understanding, are examples of the analytical support provided by our expert staff to API and drug product projects. Specific analytical capabilities include several techniques for bulk solid structure elucidation, physical characterization as well as imaging.
Since the presence of some microorganisms in a pharmaceutical product may reduce or inactivate its therapeutic activity and in a major instance adversely affect the health of the target patient, it is of great importance for the pharmaceutical industry to avoid microbial contamination.
Hovione’s microbiology laboratory gives support not only to the verification of the final product’s quality, through development and validation of microbial limit tests and endotoxins test methods, but also to the process design and production stages to assure the microbiological quality of the product.
On the process design stage it is important to evaluate all steps in order to minimize and/or eliminate possible sources of microbial and/or endotoxins contamination during the manufacturing process. To achieve this goal, Microbiology Lab is involved in activities such as: minimization of the bioburden, training on gowning and aseptic behavior, environmental and water monitoring and definition of clear Standard Operating Procedures.
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.
Hovione is equipped with a broad range of chromatography capabilities that cover the needs and demands of our projects and customers.
From classical High Performance Liquid Chromatography (HPLC) to Ultra Performance Chromatography (UPLC) Hovione equipment incorporates a variety of detector systems relevant to pharmaceutical industry applications: Photo Diode Array (PDA), UV/Visible, Fluorescence (FLD), Refractive Index (RI), Tandem Mass Spectrometry (Triple Quad; LC/MS/MS), Charged Aerosol (CAD), Amperometric and Conductivity detectors.
Hovione is also equipped with flexible gas chromatography systems capable of working with both head-space and liquid auto sampler injectors. Available detectors for these systems are flame ionization and mass spectrometry detectors.
Hovione chromatography personnel are well trained to provide Customers with a high level service in method development, method transfer and method validation activities as well as solving challenges throughout a project's lifecycle (e.g.: Genotoxic Impurities (GTIs), non-UV active impurities and other fine tuning method activities).
Hovione team conducts method development and validation for a wide variety of wet analysis techniques and compendial methods verification. Experienced and skilled analytical staff are responsible for the accurate execution of these classical methodologies still so fundamental in the quality control of pharmaceutical products.
Analytical laboratories are equipped to handle potent products up to category 3b (down to 0.03 µg/m3, OEL). Our analysts are trained in safety procedures and regularly use isolators, glove boxes and other containment systems that allow running full testing of potent products in house.