Conjugate CDMO Solutions

At the forefront of advanced therapeutic modalities, conjugate technologies represent a paradigm shift in targeted interventions. Our integrated conjugate CDMO solutions leverage cutting-edge science and robust infrastructure to overcome the inherent challenges of conjugation chemistry, linker design, and manufacturability. Explore our full suite of CDMO Solutions, including specialized support for Biologic and Conjugate CDMO Solutions.

Antibody-Drug Conjugate (ADC) Development & Manufacturing

• Payload-Linker Design & Synthesis: Rational design and GMP synthesis of novel cytotoxic payloads and sophisticated linkers (cleavable/non-cleavable), focusing on stability, targeted release, and reduced systemic exposure.
• Conjugation Process Development: Optimization of conjugation methodologies (lysine, cysteine, site-specific) to achieve high conjugation efficiency, desired drug-to-antibody ratio (DAR), and minimal heterogeneity. We develop scalable, robust processes.
• Analytical Characterization & Control: Implementation of advanced orthogonal analytical methods (HIC, SEC, MS, potency assays) for comprehensive characterization of DAR distribution, free drug/antibody, aggregates, and impurities.
• GMP Manufacturing: Scalable, dedicated manufacturing suites for conjugation, purification (TFF, chromatography), and formulation under stringent aseptic conditions.

Antibody-Oligonucleotide Conjugate (AOC) Development & Manufacturing

• Oligonucleotide Synthesis & Modification: Expertise in solid-phase synthesis, purification, and chemical modification (e.g., for stability, reduced immunogenicity) of siRNA, ASO, or other oligonucleotide payloads.
• Conjugation Strategy Development: Design and optimization of stable, biocompatible linkers and conjugation chemistries suitable for attaching oligonucleotides to antibodies or other proteins, preserving the functionality of both components.
• Characterization Challenges: Addressing unique analytical needs, including confirmation of oligonucleotide integrity post-conjugation, assessment of hybridization efficiency, and characterization of conjugate size and aggregation.
• Formulation & Delivery: Development of formulations ensuring stability of the often-sensitive oligonucleotide component within the conjugate structure.

Peptide-Drug Conjugate (PDC) Development & Manufacturing

• Peptide Discovery & Engineering: Design, synthesis, and screening of novel targeting peptides or optimization of existing sequences for enhanced receptor affinity, selectivity, and serum stability (e.g., incorporating non-natural amino acids, cyclization, PEGylation).
• Linker-Payload Integration: Rational design and synthesis of linkers optimized for controlled payload release within the target microenvironment, coupled with stable attachment to diverse therapeutic agents (cytotoxics, immunomodulators).
• Site-Specific Conjugation Chemistry: Development of robust conjugation strategies (e.g., cysteine/maleimide, click chemistry, enzymatic ligation) tailored to peptide functional groups to ensure homogeneity and preserve peptide bioactivity.
• Complex Purification & Characterization: Implementation of advanced purification techniques (preparative HPLC, chromatography) to isolate homogeneous PDC species. Comprehensive characterization of conjugate identity, purity, stability, DAR equivalence, aggregation state, and in vitro functional activity.
• GMP Manufacturing Support: Scalable process development and GMP PDC APIs, including formulation development for optimal stability.

Peptide-Radionuclide Conjugate (PRC) Development & Manufacturing

• Peptide Engineering & Radiolabeling: Design and synthesis of targeting peptides, development of efficient bifunctional chelators, and optimization of radiolabeling conditions for high specific activity and radiochemical purity.
• Rapid Process Development: Focus on streamlined processes suitable for short-lived radionuclides, including rapid purification and quality control methods.
• Dedicated Radiochemistry Facilities: GMP-compliant hot cells and shielded suites designed for safe handling and manufacturing of radioactive conjugates.
• Stability & Release Testing: Implementation of rapid, validated analytical methods for release within the constraints of radionuclide half-lives.

Small Molecule-drug Conjugate (SMDC) Development & Manufacturing

• Targeting Ligand Design: Identification and synthesis of high-affinity small molecule targeting ligands (e.g., folate, PSMA binders).
• Linker-Payload Integration: Rational design of linkers tailored for release within the target microenvironment and attachment to diverse payloads (cytotoxics, imaging agents).
• Chemical Conjugation & Purification: Development of robust chemical conjugation routes and purification strategies for homogeneous SMDC products, often involving complex organic synthesis and purification (HPLC, crystallization).
• Analytical Method Development: Characterization of conjugate structure, purity, stability, and in vitro/in vivo release profiles using techniques like LC-MS, NMR, and radiolabeling.