Analytical & Bioassay Quality Control Services
Creative Biolabs is capable of customising the biological analysis and identification packaging to meet your unique biosimilar development needs. Advanced technologies and operating procedures are employed to ensure the critical data is accurate, complies with standards, and is timely delivered, regardless of project size. Our diverse analytical methods can help you evaluate the comparability of therapeutic antibodies and proteins, which are mainly introduced from these two aspects: antibody release and antibody characterisation.
Introduction of Analytical and Bioassay Quality Control
The control and characterisation of biopharmaceuticals are defined by global scientific standards, primarily focusing on product quality attributes, which mandate a comprehensive evaluation of purity, potency, and identity. Analytical and bioassay quality control involves a harmonised suite of physicochemical and functional tests to ensure the product remains safe and effective throughout its lifecycle. This process is essential for demonstrating comparability during process changes and supporting storage data.
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Fig.1 Representative bioassays for BsAb.1
What We Can Offer
Creative Biolabs has developed a novel technology to prepare fully human antibodies with enhanced stability and reduced propensity to aggregate. Please click CreStabTM technology for preventing antibody aggregation for more details.
- ✔ Visual appearance
- ✔ Concentration detection
- ✔ HP-SEC
- ✔ HP-IEX
- ✔ Sterility test
- ✔ Bacterial endotoxin test
- ✔ ELISA (sTNF affinity)
- ✔ Residual host protein, RNA and/or genomic DNA
- ✔ Binding analysis
- ✔ In vitro biological activity
- ✔ Peptide Mapping
- ✔ CEX-HPLC
- ✔ Immunodetection
The products for antibody characterisation at Creative Biolabs not only involve the commercial aspects of therapeutic antibody pharmacokinetics but also relate to quality assurance in basic research. The following provides detailed technical resources for antibody characterisation.
| • Amino Acid Composition | • Amino Acid Sequence | • Terminal Amino Acid Sequence | • Sulfhydryl Groups and Disulfide Bridges |
| • Carbohydrate Structure | • UV280 Quantitative | • Analytical Excessive Speed Centrifugation | |
How Creative Biolabs' service Can Assist Your Projects
Highlights
Integrated Quality Strategy
We don't just run assays; we integrate analytical data (purity, PTMs) with functional data (potency, binding) to build a robust quality target product profile, minimising scientific uncertainty.
Specialisation in Complex Biologics
We possess proven expertise in designing MoA-reflective potency assays for the most challenging formats, including bispecific antibodies (BsAbs) and T-cell engagers, often utilising complex reporter gene systems to capture multi-step mechanisms.
High-Throughput Screening Efficiency
Our immunochemical assays (ELISA, binding assays) are optimised for high-volume QC screening. This efficiency - renowned for its speed, cost-effectiveness, and minimal solvent usage - accelerates product lifetime assessment and lot-acceptance timelines compared to traditional, low-throughput methods.
Unwavering Data Traceability
All data is generated under the highest quality standards, fully compliant with the ALCOA+ principles, ensuring your audit trails are impeccable and scientifically accepted.
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Customer Reviews
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Reduced Testing Time
Implementation of Creative Biolabs' analytical and bioassay quality control services has demonstrably enhanced lot acceptance efficiency, resulting in a three-day reduction in the average testing turnaround time. - M. R**n S. -
MoA Assay Reliability
Using Creative Biolabs' analytical and bioassay quality control in our research has significantly improved the reliability of our bispecific antibody potency measurement. Their reporter gene assay proved far more stable and reproducible than our in-house primary cell killing assay. - Dr. L*e P.
FAQs
How does Creative Biolabs' QC process handle complex molecules like BsAbs?
We focus on developing mechanism of action (MoA) reflective potency assays. For BsAbs, this means creating a single, robust assay (often a reporter gene system) that captures both binding domains and the resulting biological cascade, backed by specialised binding assays (SPR) to justify the surrogate potency method.
Why do you emphasise immunochemical assays (ELISA) if mass spectrometry (MS) is the "gold standard" for identity?
MS provides ultimate structural detail, but it is low-throughput and expensive. ELISA and similar assays are used strategically for high-throughput QC screening (storage monitoring time points, large lot acceptance) due to their speed and cost-effectiveness. They act as essential, rapid screening tools to confirm integrity before resorting to high-cost instrumental analysis.
Related Services
Biochemical Selectivity Panel Screening Services
High-throughput screening using standardised biochemical selectivity panels (e.g., kinase, protease, ion channel) to identify potential off-target liabilities early in the discovery phase, thereby mitigating project attrition risk.
Learn More →Cell Line Development Service
The process involves the generation of high-titer, stable producer cell lines, utilising optimised expression systems and stringent clonal selection to ensure genetic consistency and maximised protein yield.
Learn More →How to Contact Us
Creative Biolabs offers an end-to-end quality control solution that is both scientifically rigorous and strategically aligned with the highest scientific demands. Our expertise in analytical and bioassay areas can help you find the optimal solution for your research. For more requirements, just contact us or send us a query directly.
Reference
- Register, Ames C et al. "Bioassay Development for Bispecific Antibodies-Challenges and Opportunities." International journal of molecular sciences vol. 22,10 5350. 19 May. 2021. Distributed under an Open Access license CC BY 4.0, without modification. https://doi.org/10.3390/ijms22105350
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