Analytical Services
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Pharmaceutical Analytical Development & R&D Services
Avivia provides pharmaceutical analytical services, analytical method development and problem-solving throughout drug product development, from early feasibility and formulation screening to stability studies, process development and preparation for GMP manufacture.
Our analytical scientists work closely with formulation and dissolution scientists rather than operating as a separate testing laboratory. This allows analytical results to be interpreted in the context of the drug product and development question. We support analytical method development, stability-indicating methods, product characterization, degradation and impurity investigations, reverse engineering and analytical troubleshooting.
Methods developed during R&D can subsequently be verified, pre-validated and transferred to a qualified laboratory for routine or GMP testing.
Avivia provides integrated pharmaceutical R&D services in formulation, analytical development, dissolution and excipient analysis.
What Can Avivia Help You Investigate?
- Development of analytical methods for APIs, drug products and formulation studies
- Stability-indicating methods and forced-degradation studies
- Unexpected impurities, degradation products or changes observed during stability
- Analytical methods that are insufficiently selective, robust or suitable for their intended purpose
- Assay, related substances and other methods supporting pharmaceutical development
- Product characterization and comparison with reference or competitor products
- Analytical support for generic and hybrid drug product development
- Analytical support during formulation screening, optimization and troubleshooting
- API–excipient compatibility and investigation of excipient-related stability problems
- Method verification, pre-validation and preparation for analytical method transfer
- Specialized characterization where routine pharmacopoeial or compendial testing does not provide the required information
Pharmaceutical Analytical Method Development
As a pharmaceutical analytical CRO, Avivia develops analytical methods according to the development question, drug substance, dosage form and stage of the project. Avivia develops methods for pharmaceutical APIs, drug products, formulation studies and stability programs, including assay, related substances and other product-specific analytical requirements.
Method development can start during early feasibility and evolve alongside the formulation. Where appropriate, methods are subsequently verified or pre-validated and prepared for transfer to a qualified laboratory for routine or GMP testing.
Stability-Indicating Methods and Degradation Studies
Understanding degradation is often essential for selecting a formulation, establishing storage conditions and developing a suitable control strategy. Avivia develops stability-indicating analytical methods and performs forced-degradation and targeted stability investigations to distinguish the active ingredient from relevant degradation products.
When unexpected changes occur during stability, analytical results can be evaluated together with formulation composition, excipient properties, packaging, processing and storage conditions to help identify the underlying degradation pathway.
Unknown Impurities and Analytical Troubleshooting
Unexpected peaks, inconsistent results or unexplained changes in a drug product may require more than repeating the analytical test. Avivia uses a systematic analytical R&D approach to investigate potential causes such as degradation, sample preparation, method selectivity, excipient interference, interactions with laboratory materials or characteristics of the formulation itself.
Where necessary, complementary analytical techniques and targeted experiments are used to determine the origin and relevance of the observation and to develop a practical solution.
Product Characterization and Reference-Product Comparison
Analytical characterization can provide information beyond routine assay and impurity testing. Avivia supports characterization of drug substances and drug products to investigate composition, physicochemical properties, formulation differences and factors affecting product performance.
For generic and hybrid development, analytical characterization can be combined with Excipia deformulation and excipient analysis, formulation development and comparative dissolution to build a more complete understanding of the reference product.
Analytical R&D Throughout Drug Product Development
Analytical development at Avivia is closely connected to the stage and objective of the drug product development program.
A typical analytical development pathway may include:
Development question → Method feasibility → Method development and optimization → Application to formulation or stability studies → Troubleshooting and refinement → Verification or pre-validation → Method transfer
Not every project requires every step. Analytical activities can be performed as focused stand-alone studies or integrated directly into formulation, dissolution, stability and process-development programs.
This integration allows analytical results to influence development decisions while the product is being developed rather than serving only as a final measurement.
Pharmaceutical Testing and Specialized Analytical Investigations
Pharmaceutical Testing and Specialized Analytical Investigations
Analytical Method Verification and Transfer
Routine analytical methods do not always provide the information needed to understand a pharmaceutical development problem. Avivia therefore combines chromatographic and physicochemical characterization techniques to investigate product- and project-specific questions.
Depending on the development question, investigations may address physicochemical API properties, particle size and morphology, flowability, chirality, hygroscopicity, drug–excipient interactions, degradation, discoloration, extractables, solid-state behaviour and other factors affecting formulation, manufacturing, stability or product performance.
Where specialized techniques are not available in-house, complementary analyses can be performed through Avivia’s established external network.
Analytical methods developed during pharmaceutical R&D ultimately need to perform reliably in their intended testing environment. Avivia can verify or pre-validate developed methods and prepare them for transfer to a qualified analytical or GMP laboratory.
During method transfer, relevant method knowledge and development experience can be communicated to the receiving laboratory, helping address potential differences in instrumentation, materials or laboratory practice and supporting a robust transition from development to routine testing.
Analytical Method Verification and Transfer
Analytical methods developed during pharmaceutical R&D ultimately need to perform reliably in their intended testing environment. Avivia can verify or pre-validate developed methods and prepare them for transfer to a qualified analytical or GMP laboratory.
During method transfer, relevant method knowledge and development experience can be communicated to the receiving laboratory, helping address potential differences in instrumentation, materials or laboratory practice and supporting a robust transition from development to routine testing.
Advanced Excipient Characterization Through Excipia
Excipient variability can influence pharmaceutical processing, stability and product performance even when the material complies with its pharmacopoeial specification. Avivia therefore developed specialized excipient characterization expertise, now provided through Excipia, its dedicated excipient analysis and characterization platform.
Excipia investigates excipient composition, variability, chemical reactivity and Functionality Related Characteristics (FRCs) that may not be represented on a routine Certificate of Analysis. This capability can be integrated directly with Avivia’s analytical troubleshooting and formulation development when excipient properties are suspected to contribute to a drug product problem.
Analytical Techniques and Laboratory Capabilities
Avivia’s in-house analytical R&D laboratory provides a broad range of pharmaceutical analysis, chromatographic and physicochemical characterization techniques, including:
UHPLC-UV/DAD; HPLC-CAD; HPLC-RI; SEC; IC; GC-MS (single quad); GC-FID;
For dissolution and release testing capabilities, see Pharmaceutical Dissolution Testing & Development;
UV spectroscopy; microscopy, scanning electron microscope (SEM); forced degradation equipment; light-stress equipment (suntester); climate chambers and more.
Additional specialized technologies are available through our established external network.
Frequently Asked Questions
Can Avivia develop an analytical method for a new drug product?
Yes. Avivia develops analytical methods for APIs, drug products, formulation studies and stability programs. Method development can start during early feasibility and continue alongside formulation development, allowing the analytical approach to evolve as knowledge of the product increases.
Can Avivia develop stability-indicating HPLC or UPLC methods?
Yes. Avivia develops stability-indicating chromatographic methods to separate the active ingredient from relevant impurities and degradation products. Method development can be supported by forced-degradation studies and targeted stability experiments to understand degradation behaviour and demonstrate method selectivity.
Can Avivia investigate an unknown impurity or degradation product?
Yes. Unexpected peaks or changes observed during development or stability can be investigated using chromatographic and complementary analytical techniques. Where relevant, the investigation can also consider formulation composition, excipients, processing, packaging, storage conditions and sample preparation to help identify the origin of the impurity or degradation pathway.
Can Avivia troubleshoot an analytical method that is not performing reliably?
Yes. Analytical troubleshooting can address problems such as insufficient selectivity, interfering peaks, variable recovery, poor precision, sample-preparation problems or unexpected analytical results. Avivia uses systematic experiments to identify the underlying cause and adapt the method or analytical approach accordingly.
Can analytical development be integrated with formulation and dissolution development?
Yes. This is a core part of Avivia’s development approach. Analytical scientists work directly with formulation and dissolution scientists, allowing analytical results, formulation behaviour and dissolution performance to be evaluated together and translated into development decisions.
Can Avivia characterize and compare a reference drug product?
Yes. Avivia performs analytical characterization and comparison of reference and development products to support generic and hybrid drug product development. This can be combined with Excipia deformulation and excipient characterization, formulation development and comparative dissolution to obtain a broader understanding of product composition and performance.
Can Avivia investigate whether an excipient is contributing to a stability or formulation problem?
Yes. When excipient properties are suspected to influence degradation, processing or product performance, Avivia can combine analytical and formulation investigations with specialized excipient characterization through Excipia. This may include evaluation of excipient composition, variability, chemical reactivity and Functionality Related Characteristics (FRCs).
Can Avivia transfer an analytical method to a GMP or routine testing laboratory?
Yes. Methods developed during pharmaceutical R&D can be verified or pre-validated and prepared for transfer to a qualified analytical or GMP laboratory. Method knowledge generated during development can be transferred together with the analytical procedure to support a robust transition to routine testing.