Integrity Bio, Inc. combines unsurpassed formulation development expertise, process development know-how, and CGMP manufacturing capability in a single facility.
PREFORMULATION STUDIES:
We investigate the physical and biological properties of a molecule; identify key stresses and degradation products, stability indicating assays, and formulation feasible for early clinical trials
Biologics
- Physical Characterization: structure, thermal denaturation, solubility, viscosity
- Stability Indicating Assays and Stress Testing: orthogonal physical and chemical degradation products
- Clinical Formulation Selection: liquid or lyophilized
Chemical
- Liquid Formulation: solubility and stability over range of pH, excipients (PEGs, Tweens, etc) and biosimulated fluids
- Solid form selection: identify new polymorphs, optimal counter-ions for salt selection, and optimal organics for co-crystallization
FORMULATION STUDIES:
We optimize liquid, solid and lyophilized formulations for improved delivery and investigate the effect of excipients on drug substance and other parameters
Biologics
- Formulation development: optimization of formulation process based on broad screening of surfactants, pH, tonicity modifiers, bulking agents and other variables
- Long-term stability studies: 2 months to multi-year
- Drug substance compatibility: identify potential degradants and interactions with excipients and container/closure systems
- Lyophilization cycle Development: develop process for isolation and manufacturing
Chemical
- Forced Degradation: identify conditions that cause API degradation in liquid & solid formulations
- API Compatibility: identify incompatible excipients and drug products
PROCESS DEVELOPMENT:
Quickly identify and optimize key process conditions and parameters to speed and ensure successful development
Biologics
- Clinical manufacturing process: develop a scalable formulation process to take the laboratory method to clinical production
- Lyophilization scale-up: expertise to ensure the method piloted in the laboratory effectively scales to clinical manufacturing
Chemical
- Array based designs: investigate a broad parameter space for route selection and process development for catalytic and other organic transformations
- Crystallization development: identify key organic solvents and solvent systems which yield optimal solubility curves
CLINICAL CGMP FILL AND FINISH MANUFACTURING:
Specializing in small batch aseptic filling, Integrity Bio, Inc. has sized its liquid and lyophilized filling operation and documentation workflows to meet the needs of preclinical and clinical supply quantities
- Operation flexibility: both manual and automated fills
- Manufacturing requirements: meets both US and EU standards
- Lyophilization: ability to directly transfer from our lyo cycle development services
- Release and stability testing: wide range of in-house and contracted analytics