We develop peptide conjugate APIs within an integrated CMC framework spanning Pharmaceutical Development & Manufacturing, Drug Substance Development, and Peptide Therapeutics Development. Our focus is rigorous upstream design, robust analytical control, and phase-appropriate scalability tailored to peptide–drug and peptide–oligonucleotide modalities.
Overview of Peptide–Drug/–Oligo Conjugate (PDC/POC) API
Peptide conjugates combine the recognition, trafficking, or physicochemical advantages of peptides with the functional payload of small molecules or nucleic acids. Peptide–drug conjugates (PDCs) use linkers to control payload release or permanence, while peptide–oligo conjugates (POCs) enhance cellular delivery, localization, and stability of oligonucleotides such as siRNA, ASO, or PMO. The resulting hybrid architectures demand precise control of site-selective chemistry, linker responsiveness, hydrophobic–hydrophilic balance, and charge distribution. As a drug-substance class, PDC/POC APIs benefit from development pathways that anticipate manufacturability, stability, and quality-by-design from the earliest experiments.
Our Services
We provide end-to-end development of peptide conjugate APIs under a CDMO paradigm, with services organized around strategy, synthesis, analytics, and stability. Each service is delivered with phase-appropriate controls, bridging feasibility studies to robust, scalable processes.
Conjugation Strategy & Linker Design Service
We design conjugation architectures that harmonize peptide functionality with payload or oligonucleotide requirements. This includes selection of conjugation sites (e.g., engineered cysteine, lysine, N-terminus, orthogonal noncanonical handles), cleavable vs. non-cleavable linkers, and release mechanisms triggered by pH, reduction, or enzymes. We map structure–property relationships (hydrophobicity, charge density, sterics) to mitigate aggregation, maximize aqueous compatibility, and maintain sequence integrity, translating design hypotheses into executable synthetic routes.
Payload/Oligonucleotide Compatibility Assessment Service
We evaluate payload and oligonucleotide compatibility with the peptide scaffold and linker system. For small molecules, we assess functional group tolerance, solubility windows, and derived impurity risks under conjugation conditions. For siRNA/ASO/PMO, we assess strand chemistry (e.g., 2′ modifications, phosphorothioation), duplex thermal behavior, and susceptibility to depurination or backbone scission during activation/coupling. We run orthogonal feasibility matrices (solvent, pH, coupling agents) to de-risk side reactions, guide protecting-group schemes, and define a reproducible material-control strategy.
Process & Scale-Down Synthesis Development Service
We convert bench-scale proofs into robust, scale-down processes suitable for later transfer. Scope includes peptide handle installation, linker activation, conjugation kinetics optimization, quench and clean-up design, and fit-for-purpose impurity controls. We establish platformable unit operations—activation, coupling, capture, and polishing—paired with in-process controls (e.g., reaction conversion by LC–UV/MS, residual linker monitoring, payload carryover tracking). DoE is applied where appropriate to define design spaces for critical parameters, enabling consistent quality across batches.
Analytical Method & Characterization Platform Service
We build a conjugate-specific analytical toolbox: intact-mass LC–MS with deconvolution for conjugation stoichiometry; peptide mapping with targeted MS/MS for site occupancy; ion-pair RP-HPLC or anion-exchange for oligonucleotide integrity; SEC-MALS for aggregate and conjugate size distribution; capillary electrophoresis for charge variants; and orthogonal assays for linker stability and payload release (e.g., controlled pH/reductive stress). Reference standards and system suitability criteria are established early to support trending and comparability.
Stability Study Service
We run accelerated and stress studies aligned to peptide–oligo and peptide–drug liabilities—oxidation, deamidation, backbone cleavage, payload hydrolysis, and linker scrambling. Our programs are designed to elucidate degradation pathways, rank formulation and storage conditions, and establish stability-indicating methods.
Our Peptide–Drug/–Oligo Conjugate (PDC/POC) API Portfolio
Our services support common, widely adopted classes of peptide conjugate APIs:
- Peptide–small molecule conjugates (Non-Cleavable)
- Peptide–small molecule conjugates (Cleavable)
- Peptide–siRNA conjugates
- Peptide–ASO conjugates
- Peptide–PMO conjugates
- Peptide–aptamer or short DNA/RNA conjugates
- Multivalent or multi-payload conjugates
- …
We deliver peptide conjugate API development with design-led chemistry, rigorous analytics, and stability science under a unified CMC philosophy. Engage us to transform PDC/POC concepts into robust, phase-appropriate drug-substance platforms.
Our products and services are for research use only.
