Within our Pharmaceutical Development & Manufacturing framework, we operate an integrated Drug Substance Development capability dedicated to peptide modalities. Our Peptide Therapeutics Development offering focuses specifically on synthetic peptide API development—covering sequence-to-specification workflows, analytical rigor, and phase-appropriate CMC enablement for peptide drug substances.
Overview of Synthetic Peptide API
Synthetic peptide APIs are chemically assembled chains of amino acids with precisely controlled sequence, stereochemistry, and counterion content. They occupy a unique space between small molecules and larger biologics, demanding orthogonal analytical confirmation of identity, purity, and solid-form attributes. Robustness in solid-phase synthesis, cleavage/deprotection, and purification determines manufacturability, while control of sequence-related impurities, truncations, and epimers underpins quality. Scalable, solvent-efficient routes and well-characterized reference standards are essential for lifecycle management, comparability, and regulatory alignment throughout pharmaceutical development.
Our Services
We deliver a cohesive suite of CDMO services spanning route design, synthesis platform development, purification, analytical characterization, and solid-form & pre-formulation study.
Route Design & Platform Development Service
We translate a target sequence into a workable synthetic platform, selecting between Fmoc-SPPS, solution-assisted, or hybrid approaches based on sequence complexity, length, and resin compatibility. We optimize amino acid activation, coupling times, and base strengths to minimize deletion/alkylation and backbone aggregation. Cleavage/deprotection conditions are tuned to preserve labile residues and disulfide precursors, with early risk assessments for racemization and diketopiperazine formation.
Purification & Impurity Control Service
We establish phase-appropriate, scalable purification strategies—primarily reversed-phase and ion-exchange chromatography—with deliberate gradients for critical impurity resolution (short and long deletions, oxidations, deamidations, epimers). We define impurity fate and purge across the process, qualify hold times, and implement counterion exchange and desalting where needed.
Analytical Development
We build an orthogonal analytical package: UPLC/LC-MS for identity and related substances, chiral HPLC for epimer quantitation, amino acid analysis for composition, qNMR for potency assignment, ICP for residual metals, KF for water, residual solvent testing, and counterion assay. We develop and maintain primary/working reference standards with traceability, stability protocols, and characterization reports suitable for method validation later in development.
Solid-Form & Pre-Formulation Service
We also investigate polymorph tendencies, amorphous content, hygroscopicity, and salt selection (e.g., acetate, hydrochloride) to balance stability and processability. We evaluate the lyophilization feasibility of the API as needed, define robust drying conditions, and generate preliminary stability-indicating data under ICH-like stresses to guide shelf-life projections and packaging recommendations for the drug substance.
Scalability & DoE Risk-Reduction Service
Using scale-down models, we apply design-of-experiments to quantify sensitivity to key variables (coupling reagents, equivalents, solvent composition, temperature profiles). We map design spaces for high-risk steps—difficult couplings, global deprotection, and chromatography cut points—then lock scalable conditions with documented parameter ranges and in-process controls suitable for technology progression.
Our Synthetic Peptide API Portfolio
We support a broad range of commonly used synthetic peptide drug substance types. We provide, including but not limited to, development services for:
- Linear L-peptides (short to mid-length)
- Mixed-chirality linear peptides
- Single disulfide-bridged peptides
- Terminally modified peptides
- Common salt forms
- …
We convert peptide sequences into robust, specification-ready synthetic APIs through platformizable chemistry, impurity-aware purification, and orthogonal analytics. Engage us to streamline your peptide drug substance development with clarity, rigor, and phase-appropriate CMC discipline.
Frequently Asked Questions
Q1. How do you decide between pure SPPS and hybrid (solution-assist) routes for a peptide API?
We screen manufacturability risks—including aggregation-prone motifs, sterically hindered couplings, and sensitive residues—using short experiments that probe coupling efficiency and on-resin solvation. If specific junctions resist SPPS conditions, we introduce solution-phase fragment assembly or convergent coupling to improve yields and reduce related substances, while keeping the workflow compatible with downstream purification and analytics.
Q2. What controls are in place to minimize epimerization at sensitive residues (e.g., Cys, His, Ser-adjacent sites)?
We tailor activation chemistry (carbodiimide/oxyma alternatives or uronium phosphonium systems), moderate base exposure, and temperature to suppress enolization pathways. In-process chiral HPLC checkpoints quantify epimers at high-risk couplings, and we tighten acceptance ranges through DoE-defined parameter windows.
Q3. What is your approach to characterizing and controlling sequence-related impurities and truncations?
We use gradient-designed UPLC/LC-MS to baseline-separate closely eluting truncations and oxidized/deamidated variants. Fraction-directed MS and high-resolution mapping assign structures; purge studies tie impurity formation to specific steps. The control strategy sets process limits and targeted cut points so that related substances remain within acceptance criteria under normal operating ranges.
Our products and services are for research use only.
