Biopharmaceutical Characterisation &
Functional Assays
Understanding the True Nature of Molecules
At AAL Biosciences, characterisation goes beyond measurement, it is the art and science of understanding how a biopharmaceutical behaves, functions, and transforms within biological systems. With advanced cell-based platforms, molecular analytics, and immunological technologies, we decode potency, purity, mechanism of action, and long-term stability with precision fit for global regulatory pathways.
Our GLP/GMP-compliant facilities and cross-disciplinary scientific team bring together biology, chemistry, immunology, and analytical sciences to generate defensible data that accelerates your therapeutic development journey.
Necessity of Biopharmaceutical Characterisation & Functional Assays
Characterisation and functional assays uncover the identity, behaviour, and performance of every biopharmaceutical, guiding safe and reliable development.
Defines Mechanism & Function
Clarifies how a molecule binds, signals, and acts within biological pathways.
Establishes Potency & Bioactivity
Measures functional strength against reference standards to ensure consistent therapeutic effect.
Verifies Purity & Molecular Integrity
Detects impurities, HCPs, and structural changes that influence safety and efficacy.
Supports Stability & Shelf-Life
Reveals degradation, loss of activity, or formulation drift under real and accelerated conditions.
Enables Immunological Assessment
Evaluates immune activation, cytokine release, and PK/PD behaviour for clinical relevance.
Strengthens Regulatory Readiness
Provides validated, mechanism-driven data required for biosimilar, biologic, and IND submissions.
Area of Expertise
Chemical Characterisation (ISO 10993-18)
- Chemical Constituents
- Extractables
- Potential Toxic Substances
Comprehensive Biological & Toxicological Risk Assessment (ISO 10993-17)
- Conducted by UK & Europe Registered & ABT-Certified Toxicologists
- Clear assessment for regulatory submissions
- Product safety documentation
Extractables & Leachables Studies
- Supports biocompatibility assessments
- Mitigates potential patient exposure risks
- Ensures regulatory compliance for marketed devices
Toxicity Assessment
- Impurity
- Degradant