What is the typical scale of peptide you can handle?

We handle projects from milligram to kilogram quantities. The exact scale is scoped during consultation based on your needs and the complexity of the peptide sequence. Contact us to discuss your specific requirements.

How do you handle difficult sequences (e.g., aggregation-prone or long peptides)?

We evaluate each sequence for potential synthetic challenges and employ strategies such as pseudoproline dipeptides, microwave-assisted SPPS, or optimized solvent systems to overcome them. The specific approach is developed on a case-by-case basis.

What analytical methods do you use for characterization?

Standard characterization includes analytical HPLC, LC-MS, and amino acid analysis. For in-depth analysis, we also perform peptide mapping, MS/MS sequencing, and impurity profiling. The suite of methods is selected based on your project goals.

Can you provide process documentation for regulatory submissions?

Yes, we compile detailed process development reports, batch records, and analytical data packages that are suitable to support IND, CTA, or NDA filings. The level of documentation is scoped per project.

What is the turnaround time for a typical project?

Turnaround depends on the complexity of the peptide, scale, and the depth of process optimization required. This is determined during the initial consultation and agreed upon in the project scope.

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Peptide Process Development and Optimization

Peptide Process Development

We design, scale, and validate robust chemical synthesis routes for your peptide candidates, from early-stage optimization to reproducible manufacturing processes.

Custom SPPS route design and cycle optimization
Preparative HPLC purification and lyophilization
Comprehensive analytical characterization (LC-MS, AAA)
Process impurity profiling and control strategy
Documentation for regulatory submission support

Start Your Project

A Reliable Path from Sequence to Scale-Up

For biotech and pharma teams needing a partner to transform a peptide sequence into a cost-effective, reproducible manufacturing process, our service delivers end-to-end process development tailored to your molecule's characteristics. We combine deep peptide chemistry expertise with process engineering to design synthesis routes that meet your purity, yield, and scale targets.

Retrosynthetic analysis and protecting group strategy
Automated SPPS optimization for yield and purity
Scalable purification and impurity removal
Batch consistency and stability assessment

Reproducible

Scalable

Regulatory-Ready

Our Approach

Integrated Chemistry and Process Engineering

We combine peptide chemistry expertise with process engineering to deliver a synthesis route that meets your purity, yield, and scale targets while staying cost-efficient.

Core Synthesis Optimization

Our chemists evaluate your target peptide sequence to design a customized synthesis strategy using solid-phase peptide synthesis (SPPS) or hybrid solution-phase methods. We systematically optimize coupling conditions, resin choice, and protecting group schemes to maximize yield and minimize by-products.

Resin and linker selection for optimal loading
Coupling reagent and temperature screening
Automated SPPS cycle optimization
Side-chain deprotection and cleavage optimization

Scale-Up and Process Characterization

After establishing a lab-scale process, we scale it to pilot and commercial volumes while maintaining product quality. We perform process characterization, impurity profiling, and robustness studies to ensure a smooth technology transfer.

Scale-up from gram to kilogram quantities
Preparative HPLC purification method development
Impurity identification and control strategy
Batch consistency and stability studies

Quality Control

Every batch undergoes rigorous analytical testing including LC-MS, amino acid analysis, and peptide mapping to ensure identity, purity, and lot-to-lot reproducibility.

Process Robustness

We evaluate critical process parameters and define design space to ensure the process is reproducible and transferable to manufacturing facilities.

Regulatory Documentation

We compile comprehensive process development reports, impurity assessments, and batch records that support IND/NDA filings for your peptide drug substance.

Deliverables

What You Receive

Our deliverables are designed to provide a complete package of data, material, and documentation needed to advance your peptide candidate.

Process Development Package

Optimized synthesis protocol and batch records
Purified peptide (as agreed upon scale and purity)
Analytical data (HPLC, LC-MS, AAA, peptide map)
Impurity profile and control strategy report

Reporting & Support

Detailed process development summary report
Stability data and recommended storage conditions
Documentation for regulatory submissions
Technical transfer support to your manufacturing site

Service Scope

Customizable Parameters per Project

Each project is scoped case by case to match your peptide's unique requirements and development stage. The table below lists typical parameters we define in consultation with you.

Parameter	Typical Project Scope
Sequence Length	Standard peptide sequences up to approximately 50 amino acids are handled routinely; longer or more complex sequences are assessed on a case-by-case basis.
Scale	From milligram to kilogram quantities as scoped
Synthesis Method	SPPS (Fmoc/t-Boc) or hybrid solution-phase, determined per sequence
Purification Method	Preparative reverse-phase HPLC, ion-exchange, or other as needed
Analytical Methods	HPLC, LC-MS, amino acid analysis, peptide mapping, MS/MS sequencing
Impurity Profiling	Identification and quantitation of process-related impurities (deletion, truncation, oxidation, etc.)
Documentation Level	Process development report, batch records, analytical data package, regulatory support documents
Stability Testing	Accelerated and long-term stability studies based on project needs

Workflow

Our Process Development Workflow

From sequence analysis to purified peptide, our workflow follows a systematic progression to build a robust manufacturing process.

Sequence Review & Retrosynthesis

Our chemists analyze the target peptide sequence to identify potential synthetic challenges such as difficult couplings, secondary structure, or aggregation-prone regions. We then design a retrosynthetic strategy including protecting group selection and resin choice.

Resin & Protecting Group Selection

Based on the peptide properties, we select the optimal solid support (e.g., Wang, Rink amide, or other) and a protecting group scheme (Fmoc/t-Boc) to minimize side reactions and maximize coupling efficiency.

SPPS Optimization

We optimize coupling conditions—reagents, temperature, and reaction time—using automated synthesizers. We monitor each step via analytical HPLC to ensure high fidelity and adjust cycles as needed.

Cleavage & Side-Chain Deprotection

After assembly, the peptide is cleaved from the resin and side-chain protecting groups are removed under optimized conditions. We use scavengers to minimize scavenging reactions and maximize crude purity.

Purification & Characterization

Crude peptide is purified by preparative HPLC using a method developed based on analytical scouting. The purified product is lyophilized and characterized by LC-MS, amino acid analysis, and peptide mapping to confirm identity and purity.

Applications

Where This Service Fits

Our process development and optimization service is designed for peptide therapeutics at various stages, from preclinical candidate selection to clinical manufacturing support.

From Hit to Lead Optimization

When you have a lead peptide candidate, we optimize the synthesis route to supply material for in vitro and in vivo studies. Our process ensures consistent quality for early ADME and PK assessments.

Supply of high-purity peptide for in vivo efficacy studies
Process refinement to improve yield and reduce cost
Analytical support for stability and formulation screening

Scale-Up for Early Clinical Trials

As your candidate advances, we scale the process to produce kilogram quantities under cGMP-compliant conditions (per project scope). We focus on maintaining drug substance quality during scale-up.

Scale-up from lab to pilot ( grams to kilograms)
Process validation and impurity control
Documentation for IND/CTA filings

Robust Manufacturing for Registration

We support process performance qualification and validation studies, ensuring your manufacturing process is reproducible and ready for commercial production.

Process characterization studies
Impurity tracking and qualification
Stability data for registration batches

FAQ

Frequently Asked Questions

Get answers to common questions about our peptide process development service.

We handle projects from milligram to kilogram quantities. The exact scale is scoped during consultation based on your needs and the complexity of the peptide sequence. Contact us to discuss your specific requirements.
We evaluate each sequence for potential synthetic challenges and employ strategies such as pseudoproline dipeptides, microwave-assisted SPPS, or optimized solvent systems to overcome them. The specific approach is developed on a case-by-case basis.
Standard characterization includes analytical HPLC, LC-MS, and amino acid analysis. For in-depth analysis, we also perform peptide mapping, MS/MS sequencing, and impurity profiling. The suite of methods is selected based on your project goals.
Yes, we compile detailed process development reports, batch records, and analytical data packages that are suitable to support IND, CTA, or NDA filings. The level of documentation is scoped per project.
Turnaround depends on the complexity of the peptide, scale, and the depth of process optimization required. This is determined during the initial consultation and agreed upon in the project scope.

Scientific Literature

References

Zhang Y. LncRNA-encoded peptides in cancer. Journal of hematology & oncology. 2024;17(1):66. View on PubMed
Goles M, Daza A, Cabas-Mora G, et al. Peptide-based drug discovery through artificial intelligence: towards an autonomous design of therapeutic peptides. Briefings in bioinformatics. 2024;25(4). View on PubMed
Tanada M, Tamiya M, Matsuo A, et al. Development of Orally Bioavailable Peptides Targeting an Intracellular Protein: From a Hit to a Clinical KRAS Inhibitor. Journal of the American Chemical Society. 2023;145(30):16610-16620. View on PubMed

Please kindly note that our products and services are for research use only.