Pharmaceutical Analytical Development
Accelerate your drug development program by leveraging our analytical development services. We create robust, phase-appropriate methods to address well-defined parameters and prepare for future pharmaceutical product development activities. Our experts offer techniques and validation for solubility, dissolution, stability, and solid form definition. We’re experienced in evaluating and, if necessary, redeveloping existing methods to meet specific endpoints.
As a foundational activity for developing your compound, we focus highly on the integrity and performance of chromatographic methods. These methods primarily establish the assay and purity of your compound along the development pathway and are key to the success of your program.
We support your chromatographic analyses as your program advances and scientifically justify additional resources to optimize your methods. We ensure the integrity and performance of your chromatographic methods to accurately assess the purity of your compound during the development pathway. Chromatographic methods typically include reversed phase, ion pairing, ion exchange, size exclusion, and hydrophobic interaction chromatography using an array of modern detectors.
Most compounds are analyzed using UV detection. We use alternative detection methods when appropriate, such as evaporative light scattering, refractive index, fluorescence, and mass spectrometry. Our team ensures all developed methods meet specified criteria, which are determined based on the purpose of the method and the properties of the compound. By performing these comprehensive analyses, we create a compound profile that defines your sample’s identity, purity, and stability.
Based on the complexity of your molecule and program, we perform analyses with LC-MS characterization, which is the coupling of liquid chromatography and mass spectrometry. This analysis is a fundamental activity in pharmaceutical development to identify the specific primary components in a sample. Using these insights, we confirm the chemical structure of the drug and identify potential structures of chemical degradants/impurities that might arise during development. Our equipment, facilities, and staff ensure state-of-the-art execution of this activity.
Our experts analyze your liquid and solid samples with spectroscopic techniques, such as UV/VIS, fluorescence, X-Ray, IR, Raman, circular dichroism, and brightfield microscopy. All these techniques are rapid, simple, generally non-destructive, and require only small amounts of material. We utilize state-of-the-art technology and efficient data gathering by using plate-based sample handling whenever possible.
Thermal analysis reveals the physical and chemical attributes of your prospective drug, be it a small molecule, peptide, protein, or nucleic acid. Our staff has years of training and experience in various thermal techniques, enabling them to design appropriate collection methods and expertly interpret the data. These data sets are often in the form of a spectroscopic readout (UV/VIS, fluorescence) or a calorimetric readout (heat flow/heat capacity) and reveal the intrinsic thermal stability of your prospective drugs. Proper data interpretation and utilization provides substantial leverage for improving formulation and process development.
The propensity of your drug substance or formulation to absorb/incorporate water is paramount in analytical drug development, as chemical and physical changes often arise when drug materials interact with water. We employ relative humidity/temperature stability studies, which are the industry standard for assessing moisture pick-up and chemical impurities. Readouts include loss on drying in TGA, moisture content via Karl Fischer titration, and impurity analysis via chromatography. Dynamic Vapor Sorption (DVS) is additionally utilized to directly measure water absorption and release as well as its potential effect on solid form. Additionally, we produce a hygroscopicity ranking consistent with the industry and FDA standards.
Subvisible particulate matter analysis characterizes the solution properties of your formulation and assesses subvisible particle populations and aggregation potential. We use various techniques, such as dynamic light scattering and HIAC, for subvisible particle size determination and particle count measurement. These measurements are essential for proper progression through the development pipeline.
We utilize high-resolution mass spectrometry, NMR, and other techniques (e.g., elemental analysis) for detecting and identifying impurities in your samples. Collecting and expertly interpreting these data are essential activities in drug development and align with regulatory agency requirements.
Our team supports you wherever your pharmaceutical product is at in development, whether that means starting from scratch, improving, and expanding existing methods, or troubleshooting and fixing problematic methods. We take your current drug development phase into consideration to create the most efficient, high-quality methods for your specific needs.
We develop a standard operating procedure (SOP) to detail the method validation process with regard to the parameters, processes, and acceptance criteria that are applied. We follow protocols you provide or draft custom validation protocols to meet and comply with ICH and FDA guidelines. Our experience spans the spectrum of development, including Phase I, II, and III.
Our team is adaptable to your needs and conducts formal ICH stability studies following provided methods, compendial methods, or methods developed and validated by our labs. We use a formal stability tracking system that fully complies with the regulatory process. We outline and apply clear, well-defined release specifications to your drug product based on the quality control specifications and progression of your program.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.