The one-stop-shop for Neoantigen Peptide Cancer Vaccine Trials
Intavis Peptide Services is the only one-stop-shop for Neoantigen Cancer Vaccine worldwide, offering to manufacture peptide drug substance and drug product at one single site. In addition, Intavis Peptide Services offers all the necessary analytics for process validation and batch release. One vendor for everything you need for your Neoantigen Cancer Vaccine trial.
Germany has one of the toughest regulations globally and we are proud to meet them. Made in Germany promises the highest quality standards available globally.
Neoantigen Peptide Cancer Vaccine Trials
What we do
Accelerate and de-risk your neoantigen peptide cancer vaccine trial 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. In recent years we have gathered extensive experience in the manufacturing of peptide-based cancer vaccines, supplying compassionate use and clinical trials.
We are the only company globally who can provide peptide drug substance and drug product for personalized neoantigen peptide cancer vaccines from a single source.
What are Neoantigen Cancer Vaccines?
Neoantigen cancer vaccines are a promising personalized therapy designed to fight cancer using the body's own immune system. These vaccines target unique mutations (neoantigens) found on a patient's tumor, training their immune system to recognize and destroy cancer cells while minimizing harm to healthy tissues. They can be created in various ways, from off-the-shelf options to completely individualized vaccines based on a patient's specific genetic makeup.
Find more info in our blog.
Manufacturing Neoantigen Cancer Vaccine
Quality
- Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity in the performance of specific functions, ensuring consistency and compliance with GMP standards.
- Regular Audits and Inspections: Internal and external audits to assess adherence to GMP regulations, identify areas for improvement, and ensure corrective actions are implemented.
- Continuous Training: Ongoing training programs for staff to stay updated on GMP guidelines and best practices, ensuring everyone follows the required procedures accurately.
Speed
- Since patients are terminal each single day counts. The industry benchmark is at 3-5 weeks for drug substance and another 2-3 weeks of drug product, totalling 5-8 weeks in production time.
- Shipping product is one of the major factors for delay and costs in a Neoantigen Cancer Vaccine trial. Reducing shipping substantially de-risks your trial and reduces your costs of coordinating logistics.
Pooling
- Peptide pools need to be composed in a way to minimize aggregation and ensure proper analytics via HPLC. This process requires peptide expertise.
Herstellung von Peptidwirkstoffen und Arzneimitteln
We are the only one-stop-shop for Neoantigen Cancer Vaccine worldwide.
Drug Product
- Pooling of peptides
- Sterile filtration
- Fill and finish into 2R vials under aseptic conditions; up to 140 vials for each patient/peptide pool
- Comprehensive (QA/QC)
- Shipping in liquide of lyophilized form
- Release via our QP
Drug Substance Manufacturing
What we can do for your Neoantigen Cancer Vaccine trial:
- Manufacture up to 24 Peptides per batch in parallel under GMP conditions: 1mg up to 500mg and a purity of 98%.
- 3-5 weeks turn around time for manufacturing of individualized peptides via SPPS
- Release via our QP
- Depending on the regulations of the country your clinical trial is running in, we can pool peptides at the drug substance or product stage of the manufacturing process.
Analytics
As a true one-stop-shop we offer all the necessary (& optional) analytics for of DS and DP release.
DS release testing
| Variable | Method |
| Appearance | Visual inspection |
| Identity | MS |
| Purity | HPLC UV214 |
| Impurity quantification | LC MS |
| Net Peptide content | Nitrogen Analysis |
| Residual solvent | GC |
| Residual water | Karl Fischer Titration |
DP release testing
| Variable | Method |
| Sterility test | Testing in cleanroom |
| Endotoxin testing | MAT, LAL or rFC |
| Identity | MS |
| Purity | HPLC UV214 |
| Sequence confirmation | LC-MS² |
| Assay | LC-MS |
Why choose Intavis Peptide Services for your Neoantigen Cancer Vaccine trial?
We comply with German/European regulations for GMP
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We have been doing peptide synthesis for 30 years and gathered extensive experience in the manufacturing of peptide-based cancer vaccines, supplying compassionate use and clinical trials.
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Our facilities in Tübingen, Germany are new and state-of-the-art
Fast and reliable services
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We are fast, as we minimize shipping: expect your final DP within 8 weeks of sequence submission, without any hassle on your side
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Peace of mind – the risk of delays is minimized with the Intavis Peptide Services one-stop-shop
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We keep communication up at every step of the way – both ways.
Working with us
1. Initial consulting
We will evaluate your project and are happy to help you design your Neoantigen Cancer Vaccine trial.
2. Process Adaptation
While we do have an optimized standard process, which is suitable for most personalized Neoantigen Cancer Vaccine trials we can adapt to your needs.
3.Process Validation
In case of adapting our process to your specifications, we will validate the resulting new process to ensure GMP/regulatory compliance.
4. Regulatory Compliance
We support your IND/IMPD application.
5. Manufacturing
We produce your DS/DP according to GMP regulations.
6. Shipping
We ensure your product reaches your clinical trial site safe and sound.