Microbiology Testing for Biopharmaceuticals
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.
Necessity of Microbiology Testing for Biopharmaceuticals
Ensures Sterility & Safety
Confirms products are free from microorganisms, endotoxins, and pyrogens to protect patient health.
Controls Bioburden & Contamination
Monitors microbial load during manufacturing to prevent process failures and product rejection.
Validates Process Hygiene
Assesses cleanrooms, utilities, and surfaces to maintain GMP-compliant aseptic conditions.
Supports Product Stability
Identifies microbial degradation or preservative failure that may impact shelf-life and potency.
Regulatory Compliance
Meets mandatory pharmacopeial standards (USP, ISO, EP) for sterile and biologic products.
Quality & Manufacturing Integrity
Ensures consistent microbial control across batches, safeguarding product purity and reliability.
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