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