Gannet Biochem

Overview

Gannet BioChem is a specialized contract development and manufacturing organization (CDMO) focused on polymer science, polyethylene glycol (PEG) chemistry, and bioconjugation services. With a scientific legacy spanning more than 30 years—originating from Shearwater Polymers (founded 1992) and later Nektar Therapeutics—the company was spun out as an independent entity in 2024 and acquired Laysan Bio in 2026 to expand its activated polymer technologies and GMP manufacturing capabilities.

Core Capabilities

Polymer & PEG Services:

• Custom activated polymer and linker synthesis
• PEGylation and bioconjugation strategies for proteins, peptides, small molecules, and complex therapeutics
• Activated polymer services supporting development, scale-up, and manufacturing of complex materials with diverse architectures, molecular weights, and functional groups

Analytical Services:

• Analytical method development, qualification, and validation
• Characterization of polymers, PEGs, and conjugates (identity, purity, molecular weight, functionality)
• Impurity and degradation product analysis
• Stability and forced degradation studies
• Release testing for non-cGMP, GLP, and cGMP materials
• Phase-appropriate methods designed to evolve alongside therapeutic programs

Manufacturing:

• cGMP manufacturing of PEG and activated polymer reagents from early-phase batches through commercial-scale supply
• Compliant activated PEG production and bulk pharmaceutical chemical manufacturing
• Flexible early-phase capacity and established commercial-scale infrastructure
• FDA-registered facilities with 124,000 sq. ft. in Huntsville and 16,000 sq. ft. in Arab, Alabama

Project Management:

• Collaborative project management aligning scientific insight, analytical strategy, and operational planning
• Cross-functional coordination supporting programs from early research through commercial supply
• Realistic timeline and risk planning tailored to each program's stage and regulatory pathway

Track Record & Regulatory Compliance

• 9 FDA-approved therapies supported through PEG reagent supply
• 50+ global partners across preclinical and clinical programs
• 100% on-time, in-full delivery for PEG reagent manufacturing programs
• FDA-inspected facilities with rigorous documentation practices
• Comprehensive quality system designed for regulatory readiness at every development stage
• Routine support for customer audits

Modalities & Applications

The company supports therapeutic programs utilizing PEG-enabled drug delivery across multiple modalities, including small molecules, peptides, proteins, and biologics requiring conjugation or polymer-based formulation strategies.