Neoantigen Peptide Cancer Vaccine
Intavis Peptide Services is your perfect partner for the research and development around your neoantigen cancer vaccine pipeline. We support neoantigen peptide research and development projects with peptide development, high-quality peptide synthesis, analytics, and scientific CMC expertise.
What we do
Accelerate and de-risk your neoantigen peptide cancer vaccine Project with Intavis’ comprehensive CDMO service.
Intavis Peptide Services has over 30 years of experience in peptide synthesis. Moreover, it has collaborated with biotech, pharmaceutical companies, and academic research groups across the globe. We have extensive experience in the development and manufacture of high-quality peptides for research and development projects.
What are Neoantigen Cancer Vaccines?
Tumour neoantigens are peptide epitopes that arise from somatic mutations in cancer cells and are absent from normal tissue. Because they are not subject to central immune tolerance, they can be recognized as foreign by the patient's T cells, making them highly specific targets. Personalized cancer vaccines direct CD4+ and CD8+ T-cell responses against the unique mutational repertoire of an individual tumour.
These vaccines are designed by sequencing tumour and matching normal tissue, typing HLA alleles, and predicting which mutated peptides are presented and immunogenic; prioritized candidates are usually made as synthetic long peptides (~15–35 residues) and given with an adjuvant such as poly-ICLC. A 2024 Nature Communications study of 173 glioblastoma patients reported vaccine-induced T-cell responses in 90% of monitored patients and significantly longer survival in those with multiple responses. Because each vaccine is a one-off set of patient-specific, and often difficult, sequences, peptide identity, purity, and reproducible QC directly affect both immunogenicity and the interpretability of immune-monitoring data.
Development support for neoantigen-based peptide projects
Quality
- Standard Operating Procedures (SOPs): Detailed, written instructions designed to ensure uniformity in the performance of specific tasks, thereby maintaining consistency; in developing our processes, we adhere to internationally recognized principles to manufacture our peptides.
- Quality Management and Continuous Improvement: Our quality processes are regularly reviewed internally and continuously refined.
- Continuous Training: Ongoing training programs for staff to stay updated on regulatory guidelines and best practices, ensuring everyone follows the required procedures accurately.
Speed
- Given the great medical need and urgency of ill patients, the industry aims to provide personalized neoantigen peptides as quickly as possible within weeks.
- Organization of the logistics, as well as controlling export and import regulations, is also crucial to enable rapid access to urgently needed medicines to patients.
Pooling
- Choosing the right pooling strategy has a crucial impact on the success of your project
Development support for Neoantigen-based Peptide Products
Single Peptide Manufacturing
Preparing your neoantigen cancer vaccines project with Intavis:
- Neoantigen peptides can be manufactured in parallel settings to save time
- We customize our process for your case to meet the requirements of your regulatory body
Pooled Peptides
- Pooling of peptides and fine filtration
- Vialing peptide pools according to your needs
- Comprehensive analytical testing and release specification package available
- Consultation along the way for CMC-related topics
Analytics
We offer analytical method development and testing for research and development projects.
Analytical concepts for future GMP projects are being developed according to project-specific regulatory requirements.
Product testing
| Item | Method | Acceptance criteria |
| Amino Acid Sequence | LC-MS/MS (CID) USP<730>; Ph. Eur. 2.2.47 |
Complies with the expected sequence for each component |
| Appearance | Visual inspection | White to off-white powder |
| Assay | LC-MS (EIC) Ph. Eur. 2.2.29; Ph. Eur. 2.2.46 |
0.25 mg ± 30% |
| Bacterial Endotoxins | USP <85> Method C) | <50 EU/vial |
| Bioburden | Bioburden determination (Ph. Eur. 2.6.12) 2 mg/mL Compound in DMSO/H2O (1:3) |
TAMC: < 2 KBE/mg TYMC: no growth[SD1] [MS2] [PL3] |
| Container closure | Dye Ingress Test; USP <1207> | No ingress |
| Identity | ESI-MS, USP<736> | Theoretical monoisotopic mass ± 0.5 m.u. |
| Peptide Content | Nitrogen Analysis | Report value [%] |
| Peptide Purity | RP-HPLC | e.g. ≥90% |
| Residual Solvents | GC, USP<467> | Acetonitrile (ACN; Class 2): ≤ 0.041 mg/vial N,N-dimethylformamide (DMF, Class 2): ≤ 0.088 mg/vial Dichloromethane (DCM; Class 2): ≤ 0.06 mg/vial tert-Butanol/Tertiary-butyl alcohol (TBA, Class 2): ≤ 0.48 mg/vial |
| Solubility | Visual inspection | Clear solution without visible particles |
| Sterility | (USP <71> Celsis AMPi screen method) | No growth observed |
| Total Pool purity | RP-HPLC (UV); USP<621; Ph. Eur. 2.2.29 | >90% |
| Trifluoroacetic Acid Content | GC | Report value |
| Water Content | GC | Report value |
Why choose Intavis Peptide Services?
Intavis Provides:
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High flexibility & rapid conversion experience in the production of peptide-based
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Deep understanding and experience
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Leading player in neoantigen peptide manufacturing
You get:
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Open communication pathways to our staff
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Support in shaping your individual projects
Working with us
1. Initial consulting
We will evaluate your project and are happy to help you design your Neoantigen Cancer Vaccine project.
2. Process Adaptation
While we do have an optimized standard process, we can adapt to your needs with high flexibility.
3.Process Validation
In case of adapting our process to your specifications, we will validate the resulting new process to ensure regulatory compliance.
4. Technical Documentation
We provide technical and analytical documentation for your Research or Advanced Grade peptides.
5. Manufacturing
We make sure to have the right manufacturing process in place for your regulatory demands.
6. Shipping
We work with globally operating distributers and aid the process of stringent delivery according to your needs.