Analytical Insight That Reduces Risk Across Development Stages
Analytical methods play a central role in understanding product quality, guiding process decisions, and supporting regulatory readiness. Our analytical development services are designed to provide clarity at each stage of development.
We focus on aligning analytical strategies with program phase, modality, and critical quality attributes. This helps partners move forward with confidence, knowing their data support both near-term decisions and future regulatory expectations.
Experience With Complex Modalities and Challenging Materials
Gannet BioChem has extensive experience developing analytical methods for materials that present inherent complexity, including heterogeneity, polydispersity, and conjugation variability.
Our teams routinely support programs involving:
- PEGs and activated polymers
- Bioconjugates and conjugated polymers
- Small-molecule components, linkers, and degradation products
- Novel excipients and common formulation excipients
- Aggregates, sub-visible particles, and biological impurities
This experience allows us to design analytical method development services that address real-world challenges such as molecular weight distribution, end-group characterization, conjugation heterogeneity, and stability behavior. Rather than relying on a single technique, we apply orthogonal strategies intentionally, ensuring methods are robust and fit for purpose.
A Structured Analytical Method Development Process
Our analytical method development process follows a structured framework that balances rigor, efficiency, and flexibility. Each program is tailored to the specific modality, development stage, and regulatory context.
- Program understanding and target definition: Aligning on analytes, phase, critical quality attributes, and analytical objectives
- Feasibility and risk assessment: Identifying potential interferences, technical risks, and method requirements early
- Method development and optimization: Establishing selectivity, sensitivity, robustness, and stability-indicating capability
- Qualification or validation: Applying analytical method validation principles appropriate to development stage
- Method transfer and life cycle support: Supporting tech transfer, troubleshooting, and method evolution as programs advance
Specialized Analytical Capabilities for Polymers and Bioconjugates
Gannet BioChem applies advanced analytical techniques to answer complex questions around identity, purity, molecular weight, and conjugation.
Capabilities include:
- MALDI-TOF for broad polymer mass distribution and polydispersity assessment
- GPC and SEC with advanced detection for accurate molecular weight characterization
- NMR and qNMR for end-group analysis and absolute quantitation
- LC-MS strategies tailored for PEGs, activated polymers, and conjugates
- Release testing for non-cGMP, GLP, and cGMP materials
- Stability and forced degradation studies across short- and long-term conditions
Regulatory-Ready Methods Designed to Evolve
Our analytical teams have extensive experience working within cGMP environments and applying ICH guidelines across all phases of development. We have supported IND-enabling studies, clinical programs, and late-stage development, contributing data and documentation to IMPD, IND, NDA, and BLA submissions. Methods are developed with longevity in mind, ensuring they remain suitable as programs transition between phases, sites, or manufacturing scales.
Analytical Capabilities in Action
Get an inside look at our analytical development technology and teams.
A Collaborative Analytical Partner
Gannet BioChem’s analytical group combines long-standing expertise with fresh perspectives from newer team members, creating an environment that values both proven approaches and thoughtful innovation. If you are developing complex polymers, PEGylated molecules, or bioconjugates, get in touch with our analytical method development experts.
