Lab Capabilities
Avivia provides pharmaceutical formulation development, analytical R&D, dissolution development and excipient analysis from its laboratories in Nijmegen, the Netherlands. Our laboratory capabilities support drug product development from early feasibility and formulation screening through analytical and dissolution method development, stability investigations, troubleshooting, process development and preparation for manufacturing transfer.
Our formulation scientists, analytical scientists and dissolution specialists work together throughout development. This integrated approach allows analytical results, physical observations and drug-release behaviour to be interpreted in the context of the formulation and used directly to guide development decisions.
Pharmaceutical R&D Laboratory Capabilities
Avivia’s laboratory capabilities support both complete drug product development programs and focused pharmaceutical R&D investigations. Typical activities include:
- Formulation feasibility, prototype development and optimization
- Oral, parenteral, modified-release and alternative-route formulation development
- Solubility and bioavailability-enabling formulation strategies
- Pharmaceutical analytical method development and troubleshooting
- Stability-indicating methods, degradation studies and impurity investigations
- Product characterization and reference-product comparison
- Dissolution method development, comparative dissolution and troubleshooting
- Excipient characterization, variability and Functionality Related Characteristics (FRCs)
- API–excipient compatibility and excipient-related formulation investigations
- Deformulation and reverse engineering through Excipia
- Stability studies and formulation troubleshooting
- Process development and preparation for technology transfer
Integrated Formulation, Analytical and Dissolution Development
Drug product development problems rarely belong to a single scientific discipline. A change in dissolution, for example, may originate from the formulation, an excipient, the manufacturing process or the analytical method used to evaluate the product. Avivia therefore combines formulation development with analytical R&D and dissolution expertise. Where excipient properties require more specialized investigation, our Excipia platform provides advanced excipient characterization beyond routine pharmacopoeial testing. This combination allows us to investigate not only whether a drug product meets a target, but also why it behaves as it does and which formulation or development parameters can be adjusted.
From Laboratory Development to Manufacturing Transfer
Projects can range from individual analytical or formulation investigations to integrated development programs. Depending on the project, Avivia can support development from feasibility and formulation strategy through prototype optimization, analytical and dissolution methods, stability assessment and process development.
Where GMP manufacturing is required, Avivia can support CMO selection, preparation of development and technology-transfer packages and transfer of formulations and analytical methods to an appropriate manufacturing partner.