Cellular & Molecular Lab Assays for
Biopharmaceuticals

Every cell counts

At AAL Biosciences, cellular and molecular assays serve as the first window into how a therapeutic behaves at the most intimate biological scale. Through high-fidelity cell models, reporter systems, and advanced molecular analytics, we decode toxicity, mechanism of action, genetic safety, and metabolic fate long before a molecule enters in vivo studies.

Our platforms combine precision biology with regulatory alignment, empowering innovators with data that is reproducible, sensitive, and development ready.

407218559 ee4e0f01 8a78 439f b13e be73a5017bdc

Necessity of Cellular & Molecular Lab Assay

Cellular and molecular assays form the scientific backbone of biopharmaceutical 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.

Request Quote






    Scroll to Top