Drug Development
Singota’s injectable drug development services provide clients a path to deliver safe, effective, and stable products through tailored solutions for early‑phase programs. With over 20 years of parenteral expertise, we support your molecule from pre‑formulation through aseptic manufacturing, providing the expertise and infrastructure needed to support informed, client‑driven development decisions.
Pre-Formulation & Formulation Development
As injectable products progress through development, challenges such as stability, formulation robustness, and manufacturability may introduce complexity and risk. Pre‑formulation and formulation development play a key role in evaluating these factors early and informing development decisions. Singota’s scientists work with clients to assess evolving product and process considerations, adapting development approaches to align with product goals and manufacturing requirements.
- Solubility Assessments
- Excipient Selection
- pH, Buffer, Osmolality Optimization
- Method Development/Optimization
- Phase Appropriate Validation
- QC Release & In-Process Testing
Analytical Development
Our analytical development services focus on method development and optimization, as well as method transfer, verification, and validation to support program needs across development stages. Using advanced analytical technologies and integrated digital approaches for data management and traceability, we apply specialized techniques to develop phase‑appropriate, compliant methods tailored to your product.
Lyophilization Development & Capabilities
- Support for Lyophilization Development Studies
- Development/Optimization of Lyophilization Cycle
- Crystalline/Amorphous Characterization, Thermal Stability
- Differential Scanning Calorimetry (DSC), Dielectric Analysis (DEA)
- Differential Thermal Analysis (DTA), Thermoelectric Analysis (TEA)
- Freeze-Dry Microscopy, Technology Transfer for Manufacturing
Other Development Capabilities
- Analytical Reference Standard Program
- Scaled Development & Engineering Batches
- Administration In-Use & Microbial Hold Challenge Studies
- Laboratory Hand Fills – Toxicology & Development Batches
- Statistical Analysis & Process Verification