Microbiology Testing for Biopharmaceuticals

Ensuring Purity for Safety

At AAL Biosciences, microbiological integrity isn’t an afterthought, it’s the foundation that keeps every biologic, biosimilar, and injectable product safe, stable, and trustworthy. Our microbiology lab operates under stringent GMP, GLP, and pharmacopeial frameworks, delivering data that holds its ground in global submissions and withstands regulatory scrutiny.

With advanced analytical platforms, controlled cleanroom environments, and a team trained in pharmacopeial methodology, we ensure every result reflects the highest standards of precision and purity.

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Necessity of Microbiology Testing for Biopharmaceuticals

Microbiological control protects every biopharmaceutical from contamination, instability, and safety risks throughout its development and lifecycle.

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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