Clinical Development Peptide NCEs
Peptide NCE Clinical Development & CMC Services
With over 50 years of peptide experience, Bachem supports peptide NCEs from pre-clinical development through to Phase I–III trials to market approval, with research-grade and GMP-grade material, process development, and analytical support at every phase.
150+
Ongoing CMC projects
4
GMP sites globally
40
Dedicated CMC project managers
Phase-by-phase CMC journey
Bachem supports a full range of peptide modalities, including but not limited to cyclic peptides, stapled peptides, peptidomimetics, conjugated peptides, and modified peptides.
Designed for biotech and pharma sponsors moving a peptide NCE from discovery into IND-enabling studies and clinical trials, we support peptide NCEs through all phases: pre-clinical development, Phase I–III clinical trials, market approval preparation, and commercial supply.
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Pre-clinical development
Pre-clinical development
Delivering material for toxicological studies, ensuring a smooth transition to clinical studies and scale-up.
Building a robust CMC foundation ensuring regulatory readiness, reliable manufacturing processes, and a seamless transition into early clinical development.
Method development for purity including peak purity and method suitability test to ensure high quality from start to finish through clinical phases.
The first production batches are used for feasibility, toxicology studies and early process development ensuring sound project setup, while the first GMP material is produced for Phase I.
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Clinical trial phase I
Clinical trial phase I
Building clinical confidence through robust first‑in‑human data and optimized scale‑up.
Refining and expanding initial CMC (Chemistry, Manufacturing and Controls) package with updated process, analytical, and stability data to ensure regulatory compliance.
Reliable early‑phase quality data and control strategy through validated purity methods, targeted developmental stability studies, and a sound strategy for critical starting materials.
Optimized manufacturing process for scale-up and a design batch to deliver the required API amount for phase I.
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Clinical trial phase II
Clinical trial phase II
Advancing analytical methods and production process to optimally support clinical phase II and prepare for future clinical and commercial supply of API.
Expanding and optimizing the CMC package with deeper process understanding, strengthened controls, and updated analytical data to support clinical phase II.
Further definition of control strategy, continued method development and validation for release and IPC.
Advancing process design and characterization, and ensuring material supply for clinical phase II studies.
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Clinical trial phase III
Clinical trial phase III
Supporting pivotal studies with reliable large‑scale manufacturing, rigorous quality standards, and regulatory‑ready documentation.
Finalizing complete, compliant CMC documentation that supports clinical phase III application.
Generating regulatory‑compliant stability data under ICH conditions to confirm product quality and support shelf‑life assignment. Finalize control strategy.
Finalize process risk Assessment and characterization, compilation of MBPR and production of pre-PPQ batch to support Phase III studies.
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Market approval preparation
Market approval preparation
Ensuring API market approval readiness with robust regulatory documentation, compliant stability data, and validated commercial scale processes.
Preparation of regulatory documents to support application for market approval.
Generating PPQ batch stability data according to ICH requirements to support successful marketing authorization.
Completing process validation through PPQ documentation and three PPQ batches to confirm commercial readiness.
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Commercial supply
Commercial supply
Delivering consistent, compliant, and scalable commercial supply for long‑term access and market success.
Ensuring reliable, compliant commercial supply with ongoing quality oversight and regulatory support.
Robust delivery of API at required scale and quality according to customer demand and supply agreements.
Ongoing optimization of production to ensure efficiency and regulatory compliance.
A commitment to reliable CMC development services
Process development
Process strategies are tailored to each molecule, using pioneering technologies to establish robust, scalable, and phase‑appropriate manufacturing processes that support smooth progression toward clinical and commercial readiness.
Analytical development
Comprehensive analytical methods enable consistent characterization, quality control, and compliance with regulatory expectations, supporting high‑quality peptide development at every stage.
Regulatory support
Regulatory guidance and documentation frameworks help gather essential CMC information for agencies, ensuring alignment with global GMP standards and facilitating a confident path through submissions.
Project management
Dedicated project leadership provides structured planning, risk mitigation, and cross‑functional coordination to keep development activities aligned with timelines and program goals.
Explore our latest in-depth materials
Risk management in clinical trials: A case study in API production
Building a successful Peptide therapy takes more than innovation—it demands a structured CMC strategy that scales, stays compliant, and manages risk. This case study shows how Bachem helped a biotech partner streamline development, enhance manufacturing efficiency, and mitigate risks early using FMEA.
Reducing solvent consumption for large-scale Peptide manufacturing
As Peptide therapies continue to grow in demand, scalable and sustainable manufacturing has become essential. Discover how Multi-column Countercurrent Solvent Gradient Purification (MCSGP) boosts productivity, reduces waste, and delivers high‑purity Peptide APIs at commercial scale.
Why choose Bachem
Longstanding CMC expertise
Decades of peptide and oligonucleotide leadership ensures deep scientific knowhow and best‑practice CMC strategies tailored to each molecule.
End‑to‑end development support
Integrated services – from early formulation and process development to clinical materials and commercial manufacturing – support every stage of the drug lifecycle.
Proven GMP excellence
Facilities are regularly inspected and approved by leading global authorities, ensuring consistent quality, safety, and regulatory compliance.
Innovative technologies & approaches
Advanced technologies, continuous innovation, and modern manufacturing solutions drive efficiency, process robustness, and readiness for evolving therapeutic formats.
Robust risk & quality management
Structured CMC planning, detailed process understanding, and risk‑mitigation tools like FMEA strengthen reliability and accelerate regulatory readiness.
Bachem is one of the few CDMOs able to develop and manufacture both peptides and oligonucleotides under one quality system, so if your pipeline spans both modalities, explore our Oligonucleotide NCE development services.
Driving clinical development together
Specialized in the development and manufacturing of Peptide APIs for clinical trials, backed by integrated analytical and regulatory support.
FAQs
Bachem’s peptide NCE development service supports peptide new chemical entities from pre-clinical studies through Phase I–III clinical trials to market approval, providing research-grade and GMP-grade material, process development, analytical methods, and regulatory support at each stage.
Bachem operates 4 GMP sites globally.
Bachem supports all stages of peptide NCE development: pre-clinical development, Phase I, Phase II and Phase III clinical trials, market approval preparation, and commercial supply — each with phase-appropriate CMC, analytical, and regulatory activities.
Yes. Bachem assigns dedicated CMC project managers to coordinate planning, risk mitigation, and cross-functional activity across the clinical development lifecycle.