Precision-Driven Characterization of Antibody Therapeutics

With the growing complexity of antibody-based therapeutics, stringent regulatory expectations have underscored the necessity for precise, reliable, and validated analytical methods throughout the product development lifecycle. Whether for monoclonal antibodies (mAbs), bispecific antibodies, or antibody-drug conjugates (ADCs), comprehensive analytical method development is critical to ensure product identity, purity, potency, safety, and stability. At Creative Biolabs, our Antibody Analytical Method Development and Validation Service is built upon decades of industry experience and regulatory familiarity, delivering fit-for-purpose methods tailored to each project's specific stage and purpose—from early discovery to late-stage CMC support.

Creative Biolabs provides a full suite of analytical method development services to support characterization, quality control, and regulatory submission of antibody therapeutics. Our services are adapted to address both standard ICH Q2(R2) compliance and evolving regulatory requirements from global agencies such as the FDA, EMA, and NMPA. We offer:

All methods are aligned with the product's critical quality attributes (CQAs) and built to meet the expectations for Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) as needed.

State-of-the-Art Technologies Powering Robust Analysis

Our team employs an array of cutting-edge analytical technologies to ensure detailed and reproducible antibody characterization:

• Mass Spectrometry (LC-MS/MS): Peptide mapping, glycosylation profiling, post-translational modification (PTM) analysis, and intact mass confirmation.
• Chromatographic Techniques: SEC, IEX, HIC, RP-HPLC for purity, charge variant, aggregation, and hydrophobicity assessments.
• Capillary Electrophoresis (CE-SDS, icIEF): High-resolution separation of size and charge variants.
• Binding Assays: SPR, BLI, and ELISA for affinity, specificity, and bioactivity assessments.
• Potency Assays: Cell-based assays using reporter gene systems, proliferation/inhibition endpoints, or ADCC/CDC mechanisms.

Each platform is deployed and validated by our scientific experts with an in-depth understanding of analytical science and regulatory context.

A Streamlined Process with Scientific Rigor

To ensure a seamless project execution, we implement a structured workflow guided by scientific rationale and project-specific considerations:

Advantages That Set Us Apart

Choosing Creative Biolabs means working with a partner who understands both science and regulatory compliance. Our key strengths include:

End-to-End Expertise

From early discovery assays to validated methods, we support all phases of product development.

Flexible and Adaptive

Custom-tailored method designs that align with your timeline, risk tolerance, and budget.

Cross-Platform Integration

Coordinated deployment of orthogonal technologies for comprehensive CQA coverage.

Rapid Turnaround

Efficient development timelines without compromising data integrity or scientific rigor.

Partner with Creative Biolabs for Analytical Excellence

At Creative Biolabs, we are not merely a service provider—we are a strategic partner committed to the success of your antibody program. Our collaborative approach ensures transparency, communication, and adaptability throughout the lifecycle of analytical method development and validation. Whether you are in early preclinical stages or preparing for commercial filing, we have the technical capacity and regulatory insight to ensure your analytical package meets the highest global standards.

Reach out to us today to discuss your antibody analytical method needs and learn how our solutions can accelerate your path to research and market.

For research use only. Not intended for any clinical use.