Our integrated CDMO services support therapeutic programs from early development through commercial supply. With deep experience in polymers, PEGs, and conjugated systems, our teams combine analytical expertise and cGMP manufacturing, providing continuity that helps reduce risk, streamline decision-making, and support reliable scale-up. Across our Alabama manufacturing sites, we support programs ranging from gram-scale research materials to kilogram-scale compliant production and commercial cGMP supply.

Project Management

Project management at Gannet BioChem supports successful execution across development and manufacturing by aligning scientific insight, analytical strategy, and operational planning. Our teams set realistic expectations early, coordinate cross-functional efforts, and maintain clear communication to help programs progress efficiently while safeguarding time, resources, and quality. Our experience supporting both custom and catalog activated PEG programs enables us to align development strategy with each program’s stage, regulatory pathway, and long-term supply goals.

Team members working together in an analytical lab
A polymer scientist in a laboratory with expertise in analytical method development and validation

Analytical Method Development & Validation

Our analytical development services provide the insight needed to guide complex programs forward with confidence. Gannet BioChem develops and validates methods that are scientifically sound, phase-appropriate, and designed to evolve alongside your molecule. With extensive experience in polymers, PEGs, and bioconjugates, our teams support clear understanding of critical quality attributes, informed process decisions, and health authority data packages. Our analytical capabilities also support compliant manufacturing environments, including comprehensive characterization and release testing of activated PEG and bulk polymer reagents.

cGMP Manufacturing

Gannet BioChem’s cGMP manufacturing capabilities support production of PEG and activated polymer reagents from early-phase batches through commercial-scale supply. All manufacturing is performed at our facilities. With flexible early-phase capacity and established commercial-scale infrastructure, we help partners scale efficiently while maintaining the quality, consistency, and delivery reliability their programs require.

A member of the Gannet BioChem cGMP manufacturing team

Frequently Asked Questions

Explore what our services include and how they benefit our clients.

Gannet BioChem provides integrated CDMO services designed specifically for polymer-based therapeutics, supporting programs from early development through commercialization. Core services include polymer and bioconjugation process development, project management, analytical method development and validation, and cGMP manufacturing.

Project management is highly collaborative and customer focused, supporting programs across development and manufacturing stages. Project managers work closely with scientific, analytical, quality, and manufacturing teams to translate technical complexity into clear, achievable plans. By aligning early on scope, objectives, timelines, and risks, PMs help set realistic expectations, maintain transparent communication, and adapt plans as programs evolve.

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Gannet BioChem balances scientific complexity with execution by pairing deep technical fluency with disciplined program planning. Our teams understand the nuances of polymer chemistry, conjugation behavior, and analytical control, allowing them to anticipate challenges that may impact timelines or scalability. This insight is translated into phase-appropriate plans that outline dependencies, risks, and decision points, enabling informed adjustments while keeping programs moving forward efficiently and responsibly.

Gannet BioChem offers comprehensive analytical services that support polymer, PEG, and bioconjugate programs throughout development. Capabilities include:

  • Analytical method development, qualification, and validation
  • Characterization of polymers, PEGs, and conjugates (identity, purity, molecular weight, and functionality)
  • Impurity and degradation product analysis
  • Stability and forced degradation studies
  • Release testing for non-cGMP, GLP, and cGMP materials

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Complex polymer programs often face challenges related to molecular heterogeneity, polydispersity, conjugation variability, and limited analytical sensitivity for certain materials. PEGs and activated polymers, for example, can complicate molecular weight assignment, impurity detection, and end-group characterization.

Gannet BioChem addresses these challenges by applying orthogonal analytical strategies, specialized polymer-focused techniques, and deep experience interpreting complex data, ensuring methods are fit for purpose and supportive of both development decisions and regulatory expectations.

Analytical strategies at Gannet BioChem are designed to be phase appropriate, evolving alongside the therapeutic program. Early-stage methods prioritize feasibility, speed, and process understanding, while later-stage methods emphasize reproducibility and regulatory compliance. By aligning analytical objectives with critical quality attributes and program phase, our teams ensure data support immediate needs while remaining suitable for tech transfer and regulatory submissions.

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Tech transfer at Gannet BioChem is a structured, collaborative process designed to support efficient and reliable scale-up. The process begins with a thorough review of the client’s technical package, analytical methods, and target specifications to identify critical parameters and potential risks. From there, a phase-appropriate transfer plan is developed, including defined deliverables, analytical strategies, and scale-up considerations, with ongoing communication and milestone tracking to ensure a robust, reproducible process ready for cGMP execution.

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