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.

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Necessity of Biopharmaceutical Characterisation & Functional Assays

Characterisation and functional assays uncover the identity, behaviour, and performance of every biopharmaceutical, guiding safe and reliable development.

Area of Expertise

Chemical Characterisation (ISO 10993-18)

Chemical Characterisation (ISO 10993-18)

  • Chemical Constituents
  • Extractables
  • Potential Toxic Substances
Analyses materials used in medical devices to identify chemical constituents, extractables, and potential toxic substances. These studies provide the foundation for evaluating biological safety and regulatory compliance.

Comprehensive Biological & Toxicological Risk Assessment (ISO 10993-17)

Comprehensive Biological & Toxicological Risk Assessment (ISO 10993-17)

  • Conducted by UK & Europe Registered & ABT-Certified Toxicologists
  • Clear assessment for regulatory submissions
  • Product safety documentation
Integrates chemical data, material properties, and published toxicological information to evaluate risks to patients.

Extractables & Leachables Studies

Extractables & Leachables Studies

  • Supports biocompatibility assessments
  • Mitigates potential patient exposure risks
  • Ensures regulatory compliance for marketed devices
Examines substances that may leach from device materials under real-use conditions.

Toxicity Assessment

Toxicity Assessment

  • Impurity
  • Degradant
Evaluates potential toxic effects from impurities or degradation products that may arise during manufacturing, storage, or use, helping ensure that devices remain safe over their intended lifespan.

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