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Neoantigen Peptide Service

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Neoantigens are immunogenic peptides generated by tumor-specific mutations and are key biomarkers that distinguish cancer cells from normal cells. CD Formulation provides a one-stop neoantigen peptide service solution, from research laboratories to cGMP-compliant manufacturing facilities.

What Are Neoantigen Peptides?

Neoantigens are novel cancer antigens that are expressed in tumor tissues but not in healthy tissues. They are unique to individual tumors and are ideal targets for personalized immunotherapy. Neoantigens are generated through mutations and are highly specific. They are not recognized as self-antigens, resulting in a strong immune response. Neoantigen peptides (neoantigens) represent a new type of tumor-specific immune target, providing new ideas and methods for cancer immunotherapy.

Fig. 1 Neoantigen Peptide design and production.Fig. 1 Peptide design and production for a personalized neoantigen vaccine. (Truex NL, et al., 2020)

Explore Our Custom Neoantigen Peptide Synthesis Services

CD Formulation is a vendor of personalized neoantigen peptides that are on-time delivered and can be used as drug substances for therapeutic cancer vaccine trials, as direct injection for peptide vaccines, and as starting material for cell-based vaccines.

Over these years, we have developed and become the expert in analytic services regarding neoantigens, and even we can change the process so as to be possible for small quantities of peptides and deliver them in a short time. Our mastery of and passion for efficiency allow us to develop analytical services on the leading edge of neoantigen science. With our expertise and obsession with efficiency, we are proud to offer cutting-edge analytical services that meet the needs of the rapidly evolving neoantigen field.

  • Length: <42 amino acids (typically 16-35 aa).
  • Quantity: Multiple individual peptides.
  • Purity: 90%, 95%, 98%.
  • Counterions: Trifluoroacetic acid (TFA), acetate, or chloride.
  • Robust QC testing properties.

Available Neoantigen Peptide Options

Short Neoantigen Peptides

Short peptides (8 to 12mers, either singly or mixed) can be used to load MHC (major histocompatibility complex) class I molecules directly - onto synthetic polymers or antigen-presenting cells to activate or stimulate cytotoxic T cells.

This class of peptides can be used directly in cytotoxic T-cell stimulation assays to assess their reactivity to specific neoantigens. In addition, short peptides can be used to activate patient or donor T cells for T cell therapy targeting neoantigens.

Long Neoantigen Peptides

If the peptide needs to be processed by antigen-presenting cells, our experts recommend using long neoantigen peptides (17 to 40mers). This may include using different delivery methods to ensure cellular uptake of the neoantigen peptide.

Alternatively, we will help you combine short tumor neoantigen peptides with other functional short peptides into long peptides. The functional part can be used to tag the tumor neoantigen to another molecule for targeted delivery, self-assemble into nanoparticles, or add peptide adjuvants to the tumor neoantigen.

Crude Neoantigen Peptide Library

The purity level of the neoantigen peptide is selected depending on the application and the length of the peptide.

For screening large numbers of short peptides, CD Formulation's crude peptide libraries are ideal. Our team has optimized the synthesis procedures to achieve high success rates and purity – even for "20+" peptides. With the option to QC 100% of your peptides, you know the quality of your peptide input and can start screening in as little as 3 weeks.

Our peptide experts have designed and synthesized a crude neoantigen peptide library containing a variety of short peptides and successfully used it in T-cell stimulation assays, such as labeled MHC multimers for FACS fluorescence-activated cell sorting.

Advantages of Our Neoantigen Peptide Manufacturing Platform

Neoantigen peptides usually vary in length, charge, and hydrophobicity, which makes synthesis and purification difficult. At CD Formulation, we launched a new neoantigen manufacturing platform with the following advantages:

  • Rapid manufacturing, quality control, and release.
  • Most projects are completed within 2-3 weeks.
  • Automated and manual synthesis.
  • Flexible and adaptable synthesis methods can increase the success rate.
  • Guaranteed high quality of customized neoantigen peptides, produced in accordance with GMP standards.
  • Provide peptide pool recommendations based on solubility testing of individual peptides.

Peptide Manufacturing & Analytical Services

In addition to peptide synthesis capabilities, we combine flexible GMP manufacturing facilities with cutting-edge peptide analytical knowledge to provide a full range of quality control testing services to accelerate the commercialization of your products, including:

  • Peptide identification (ESI-MS).
  • Peptide Molecular weight determination.
  • Peptide sequencing.
  • Peptide quantification/peptide content determination.
  • Peptide purity and impurity analysis (HPLC/UV).
  • Amino acid sequence.
  • Amino acid composition determination.
  • Net peptide content.
  • Enantiomeric purity testing (GC/MS; LC).
  • Residual counterion testing (e.g. TFA).
  • Elemental analysis.
  • Residual solvent testing.
  • Water content testing (GC or KF).
  • Peptide solubility testing.
  • Peptide stability testing.
  • Optical rotation determination.
  • Bioburden testing(TAMC/TYMC).
  • Bacterial endotoxin testing.
  • Sterility testing.
  • Cytotoxicity testing.
  • Process/product related impurity testing.
  • Other pharmacopoeia testing.

Why Choose Us for Custom Modified Peptide Synthesis?

  • Expert team: CD Formulation has project managers and product experts with deep knowledge of peptide chemistry to ensure seamless integration of project requirements and production processes
  • Advanced tumor neoantigen peptide screening algorithm: CD Formulation uses heterogeneous expression profiling analysis (HEPA ) can quickly screen genes with similar expression profiles to classic tumor-specific antigens from the human genome containing tens of thousands of genes.
  • Rich experience in peptide synthesis: CD Formulation has unique technology for difficult-to-synthesize peptides, controls peptide impurities such as TFA, organic residual solvents, and endotoxins, and independent synthesis lines will not produce cross-contamination.

Publication

Published Data

Technology: Automated Peptide Synthesis for Neoantigen Vaccine Manufacturing

Journal: Pharmaceutics.

IF: 6.88

Published: 2022

Results:

The authors developed a personalized neoantigen-based vaccine formulation (FRAME-001) for a Phase II trial in advanced NSCLC. FRAME-001 consists of four peptide mixtures, each containing six peptides. Selected tumor neoantigen peptides were synthesized by utilizing a high-throughput synthesis platform and processed into an aqueous peptide mixture (drug product) under good manufacturing practice (GMP) conditions. A risk-based approach was used to develop a GMP manufacturing process and validated stability-indicating analytical methods. The compatibility of the vaccine adjuvant Montanide ISA 51 VG blend with the drug product was investigated by emulsion stability studies, and an extensive stability study was performed. The results showed that the drug product had a shelf life of 32 weeks when stored at −25°C or −80°C. These data suggest that FRAME-001 is a feasible personalized vaccine formulation for the treatment of stage III-IV NSCLC.

Fig. 2 Neoantigen vaccine formulation (FRAME-001).Fig. 2 Schematic representation of the entire manufacturing process of neoantigen vaccine formulation (FRAME-001). (Oosting LT, et al., 2022)

CD Formulation is an experienced and trusted partner in the supply of personalized neoantigens. Please don't hesitate to contact us if you would like to learn more about the possibilities of your peptide modification. We look forward to cooperating with you.

References

  1. Truex NL, Holden RL, Wang BY, et al. Automated Flow Synthesis of Tumor Neoantigen Peptides for Personalized Immunotherapy. Sci Rep. 2020,10(723).
  2. Chen X, Yang J, Wang L, et al. Personalized neoantigen vaccination with synthetic long peptides: recent advances and future perspectives. Theranostics. 2020 May 15;10(13):6011-6023.
  3. Oosting LT, Franke K, Martin MV, et al. Development of a Personalized Tumor Neoantigen Based Vaccine Formulation (FRAME-001) for Use in a Phase II Trial for the Treatment of Advanced Non-Small Cell Lung Cancer. Pharmaceutics. 2022; 14(7):1515.
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