Advanced Testing Solutions for Complex Biologic Products
Biotechnology products—biologics, biosimilars, and ATMPs—are complex entities requiring specialized analytical approaches. Testing must confirm structure, biological activity, purity, and safety per **ICH Q5** and pharmacopeial requirements.
BQCIS laboratories provide comprehensive physicochemical, bioassay, and microbiological testing using high-resolution analytical platforms. Our validated methods ensure critical quality attributes remain consistent across manufacturing batches and product lifecycle.
We support global submissions with validated data packages for vaccines, monoclonal antibodies, and recombinant proteins—ensuring each biologic meets the highest standards of identity, potency, and safety.
Key Biotechnology Testing Services
Key Benefits of Biotechnology Testing
Scientific Reliability
Validated analytical and biological methods deliver data integrity essential for biologic approval submissions.
Accelerated Development
Integrated testing workflows streamline comparability and stability studies, reducing development timelines.
Regulatory Confidence
Data packages aligned with ICH Q5 and pharmacopoeial guidance ensure rapid global regulatory acceptance.
Enhanced Patient Safety
Rigorous bioassay validation and viral-safety testing protect patient well-being across the therapeutic lifecycle.
Success Story
Validated Potency Assay Enables Biosimilar Market Entry
A biosimilar developer required a validated potency assay to demonstrate equivalent efficacy to a reference monoclonal antibody.
BQCIS designed and validated a custom ICH Q2-compliant bioassay assessing linearity, accuracy, and precision—meeting global regulatory expectations.
The validated assay supported a successful comparability submission, enabling Phase III clinical advancement without regulatory delay.