Reducing Risk and Variability Through Seamless Method Continuity and Regulatory Alignment
QC testing that meets regulatory requirements from IND, NDA, BLA, and beyond.
Streamline quality control (QC) batch release and stability testing with BioAgilytix’s integrated CMC analytical approach. By uniting assay development and QC execution within a single expert team, we minimize handoffs, eliminate silos, and deliver consistent, validated results. This approach reduces variability, accelerates timelines, and strengthens your regulatory confidence. With the scalability to handle high sample volumes and built-in redundancy across global labs, we ensure continuity and capacity to meet your program’s needs.
From molecule to market: A single team driving analytical success
The team that develops and qualifies your assay is the same team that executes your stability and release testing—ensuring knowledge, experience, and critical method parameters are maintained.
- No transfer from analytical development to QC, eliminating risk of operator variability
- Critical method parameters are preserved, reducing training gaps and execution errors
- Harmonized quality systems across global laboratories, ensuring continuity
- Global SME support for all stages of your therapeutic lifecycle, keeping projects on track
Robust method transfer strategies that meet global regulatory standards
We apply a templated, risk-based method transfer process informed by FDA, EMA, USP, and ICH guidelines. Our strategies evolve with your program, from early-phase flexibility to late-phase regulatory readiness, ensuring assay reproducibility across sites and conditions.
- Side-by-side method comparisons with statistical analysis
- Acceptance criteria and controls aligned with ICH guidelines and USP standards
- Integrated quality management systems, with SOPs and protocols that meet global regulatory expectations
- Internal risk assessments and transfer protocols established for US/EU labs
QC testing for a wide range of modalities
Our GMP-compliant labs support global release testing and stability programs across most modalities, such as:
- Monoclonal antibodies (mAbs)
- Bi/Tri-specific antibodies
- Antibody-drug conjugates (ADCs)
- Proteins and peptides
- Fusion proteins
- Vaccines
- Gene therapies
- Cell therapies
Integrated CMC analytical support throughout the drug development process
Whether you’re optimizing your manufacturing process, assessing drug stability, or preparing a comparability package, our consultative, science-forward approach leads to the best solutions for your therapeutic.