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Peptide CMC Development

Lifecycle-spanning CMC strategies to support scalable, regulatory-ready peptide programs.

CMC Decisions That Scale with Your Program

For peptide therapeutics, early CMC decisions shape how efficiently a peptide program moves through development and whether it can scale beyond the clinic.

Our integrated CMC development brings drug substance, drug product, analytical development, and regulatory activities together and advances them in parallel. This approach helps shorten development timelines and supports a smoother transition from early development to clinical and commercial supply.

API Process Development & Manufacturing

We provide peptide API process development and manufacturing using solid-phase peptide synthesis, with total SPPS capacity exceeding 100,000 L, supporting clinical and commercial supply.

Process development covers coupling efficiency, resin handling, solvent usage, throughput, and batch consistency. Hybrid solid-phase and liquid-phase approaches are applied where appropriate for long sequences, modified peptides, and complex structures.

Purification strategy is defined alongside API process development. Peptide purification is supported using continuous flow chromatography, ion-exchange chromatography, and reverse-phase chromatography for both clinical and commercial manufacturing.

Advanced peptide chemistries, including click chemistry, KAHA ligation, and ring-closing metathesis, are supported with established routes suitable for downstream purification and control.

Drug Product Manufacturing

Peptide drug product development and manufacturing is supported for both parenteral and oral dosage forms. Formulation development is aligned with peptide physicochemical properties, stability behavior, and intended clinical use.

Parenteral formulation development supports clinical and commercial manufacturing requirements. Oral peptide formulation capabilities enable early evaluation of non-injectable delivery approaches alongside drug substance development.

Formulation activities are coordinated with drug substance and analytical development to support transition into manufacturing and continuity through later stages.

Parenteral Drug Products

Analytical Capabilities

Key analytical strengths include in-house amino acid analysis and enantiomeric (chiral) purity assessment to confirm composition and quantify D-isomer impurities, peptide mapping for identity confirmation, and LC-MS/MS–based sequence confirmation for linear, branched, and multi-cyclic peptides. Advanced impurity profiling using multi-dimensional LC-MS supports detailed impurity separation and identification when higher analytical resolution is required.

For peptide programs intended for BLA filing, analytical support focuses on Bio-ID and bio-assay method transfer, qualification, and validation to meet late-stage regulatory expectations, ensuring continuity with established analytical strategies.

Analytical laboratories are co-located with peptide API process development, enabling close collaboration between analytical and process teams to support efficient execution, troubleshooting, and method transfer as programs advance.

Regulatory Dossier Preparation

Our global regulatory dossier preparation teams have extensive experience in global filings for IND, IMPD, and NDA submissions with the US FDA, EMA, and China’s NMPA. By integrating CMC dossier preparation with our API and drug product development and manufacturing, we can expedite the timeline to IND and NDA.

Green Peptide Manufacturing

Sustainability considerations are incorporated into peptide process development and manufacturing as programs advance toward larger scale. Process optimization focuses on reducing material usage, solvent consumption, and waste generation.

Improvements include enhanced coupling efficiency, streamlined processing steps, and optimized purification approaches. These practices are applied while maintaining peptide quality, process robustness, and suitability for clinical and commercial manufacturing.