CASSS Mass Spectrometry Symposium 2026

How do I transfer an LC-MS method into GMP testing?

Successful method transfer requires more than simply reproducing an analytical procedure. It involves evaluating method performance, documenting critical parameters, assessing robustness, and demonstrating reproducibility within a GMP-compliant laboratory. BioAgilytix supports method transfer, optimization, and phase appropriate validation to help ensure analytical methods are ready for regulated testing and commercial manufacturing.

What analytical validation strategy is appropriate for my development phase?

Validation requirements evolve throughout development. Early-stage programs often require phase-appropriate qualification, while later-stage clinical studies and commercial products require more comprehensive validation aligned with regulatory expectations. Our scientists work with sponsors to develop validation strategies that match each stage of development while supporting future regulatory submissions.

How can LC-MS support product characterization?

Mass spectrometry provides detailed insight into molecular structure, identity, purity, and critical quality attributes. LC-MS can support characterization of peptides, proteins, oligonucleotides, antibody-drug conjugates (ADCs), and other complex therapeutics, helping sponsors better understand their product while generating data that supports development and regulatory decision-making.

What testing is required before commercial lot release?

Commercial lot release testing typically includes validated analytical methods that verify identity, potency, purity, strength, and other product- specific quality attributes. Testing requirements vary based on the therapeutic modality, manufacturing process, and regulatory expectations. BioAgilytix performs GMP analytical testing that supports product release and ongoing commercial quality programs.

How do I prepare analytical methods for regulatory submissions?

Preparing methods for regulatory submission begins with developing robust analytical procedures supported by appropriate qualification or validation, thorough documentation, and data generated under applicable quality standards. BioAgilytix helps sponsors develop regulatory-ready analytical methods designed to withstand agency review while supporting IND, BLA, NDA, and commercial manufacturing activities

Can one partner support analytical development through commercialization?

Yes. BioAgilytix provides integrated CMC analytical development and GMP testing services designed to support programs from early development through commercial manufacturing. Our global laboratory network helps sponsors maintain analytical continuity across method development, characterization, validation, GMP testing, stability studies, and commercial lot release.

Why is product characterization important during CMC development?

Comprehensive product characterization helps establish a clear understanding of a therapeutic's structure, purity, potency, and critical quality attributes. These data support process development, manufacturing consistency, comparability studies, and regulatory submissions, ultimately helping reduce development risk and strengthen product quality throughout the lifecycle.

When should sponsors begin planning GMP analytical testing??

Planning for GMP analytical testing early in development can reduce delays later in the program. Early collaboration allows sponsors to align analytical development, method transfer, validation, and quality expectations before entering pivotal studies or commercial manufacturing, creating a more efficient path toward regulatory readiness.