FORMULATION DEVELOPMENT
Understanding Your Product’s Personality
Formulation development at Altruist begins with the end in mind. We work with you to develop a robust formulation for your drug substance or drug product to ensure stability and efficacy of your molecule during preclinical, clinical, or commercial use.
Innovative Formulation Solutions
Our approach blends high-throughput technologies with regulatory-approved components and advanced analytics – ensuring your biologic is ready for every stage ahead.
Additional services include:
- Formulation and DP process development
- Container closure system development
- In-use stability and administration studies
- Formulation process characterization
- Late-stage formulation optimization
- High concentration development and formulation robustness studies
Our Capabilities
pH, Buffer Type & Excipient Screening
Identify optimal pH, excipient types, and ranges to assess DoE robustness
Surfactant Screening
Evaluate surfactants, agitation, and freeze/thaw stability
Stress Testing
Determine degradation pathways
Stability Testing
Real-Time
Six or more months to evaluate final formulation
Accelerated
Estimate long-term stability under pre-established conditions
Stressed
Evaluate formulation stability at extreme conditions (higher temperatures, photostability, freeze-thaw, oxidation and agitation, etc)
HIGH CONCENTRATION SERVICE
Altru-CON
Altruist Biologics’ high-concentration formulation platform enhances therapeutic efficacy and improves patient compliance to make self-administration easier. It enables rapid screening of over 40 buffer systems and over 30 excipient combinations, effectively reducing viscosity and enhancing stability. It supports concentrations up to 200 mg/mL and has successfully advanced multiple projects of various modalities.
- Two commercial projects with high concentration in autoinjector
- High concentration formulation up to 200 mg/mL of complex molecules (BsAb, ScFv, Fusion Protein and TsAb)
Contact
Ready to Discuss Your Project?
Our technical experts are here to support you every step of the way. Connect with our team to discover more of our development services.
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