Labs, Manufacturers & Treatment Sites
Getting a personalized cancer vaccine requires coordination across multiple specialized providers. This directory covers the sequencing labs, vaccine manufacturers, and administration sites involved in the process.
Information verified March 2026. Availability and pricing may change. Always confirm directly with providers.
How the Provider Chain Works
No single company handles the entire personalized vaccine process. It requires a chain of specialized providers, each handling one step. Understanding who does what helps patients and physicians navigate the system.
1. Sequencing Lab
Decodes tumor + healthy DNA
~4 weeks
2. Bioinformatics
AI identifies vaccine targets
~4-6 weeks
3. Manufacturer
Builds the custom vaccine
~12-14 weeks
4. Shipping & QC
Cold-chain delivery to clinic
5. Physician
Files IND, administers 7 doses
The Existing Blueprint: JLF Partner Chain
The Jaime Leandro Foundation is currently the only organization coordinating personalized cancer vaccines through expanded access at scale. Their partner chain represents the proven model for how this process works in practice.
NoRD Bio — Cambridge, MA
Bioinformatics and neoantigen target identification using pVAC-Seq pipeline
CSBio — San Jose, CA
GMP peptide synthesis and vialing. JLF's primary manufacturing partner.
xCures — San Francisco, CA
AI platform managing the patient journey, coordination, and data
Washington University — St. Louis, MO
Vaccine design support and academic collaboration
Administering Physician — 5 sites
Files the IND application with the FDA and administers 7 vaccine doses
JLF administration sites: San Francisco, Los Angeles, St. Louis, Miami, Dallas
Patients served: 48 completed protocol, 24 in queue (as of August 2025)
Source: Jaime Leandro Foundation FAQ
Genomic Sequencing Labs
The first step in creating a personalized vaccine is sequencing the tumor's DNA alongside healthy tissue to identify mutations. Not all sequencing products are equivalent — full whole exome sequencing (WES) provides the broadest view, while targeted panels cover fewer genes.
Tempus
Full ExomeTempus is one of the largest genomic sequencing platforms in oncology. Financial assistance programs are available for qualifying patients.
tempus.com/oncology/genomic-profilingCeGaT
Exome + Vaccine DesignCeGaT (Germany) offers the most comprehensive single product — sequencing, HLA typing, and neoantigen prediction bundled together. This is diagnostics and vaccine design only; manufacturing is separate and costs approximately 39,000 EUR additional through partner labs.
Pricing from a published patient account, not listed on CeGaT's website.
cegat.com/diagnostics/tumor-diseases/cancerneoFoundation Medicine
Targeted PanelWidely used in oncology for treatment matching. However, 324 genes is a targeted panel, not a full exome — it may miss neoantigen targets that a full WES would catch. Best used as a first step or complement to full exome sequencing.
foundationmedicine.comGuardant Health
Liquid BiopsyLiquid biopsy (blood draw instead of tissue biopsy). Fastest turnaround but too narrow for vaccine design — 74 genes is insufficient for comprehensive neoantigen identification. Useful for monitoring but not for initiating the vaccine process.
guardanthealth.comWhich do you need? For personalized vaccine design, full whole exome sequencing (Tempus xE or CeGaT CancerNeo) provides the most comprehensive data. Targeted panels (Foundation Medicine) and liquid biopsies (Guardant) are useful for other purposes but may miss important neoantigen targets.
Vaccine Manufacturers (GMP Peptide CMOs)
Once neoantigens are identified, a contract manufacturing organization (CMO) builds the custom vaccine under GMP (Good Manufacturing Practice) conditions. Each patient's vaccine is a unique batch manufactured in a cleanroom with individual quality testing.
| Manufacturer | Location | GMP Status | Notes |
|---|---|---|---|
| CSBio | San Jose, CA | GMP | JLF's current manufacturing partner. Established track record with personalized peptide vaccines. |
| GenScript | China + US | GMP | End-to-end capability: vaccine design through GMP production. FDA-audited (March 2025). |
| AnaSpec | Fremont, CA | ISO 7 | Expedited turnaround. Supports peptide vaccine API through Phase I and emergency IND applications. |
| Biosynth | Netherlands | GMP (EudraLex) | Clinical trial-grade manufacturing. Strong batch consistency for multi-peptide formulations. |
| CPC Scientific | Sunnyvale, CA | cGMP | Five FDA inspections passed. New US facility opening 2026. Supports 50+ countries. |
Sources: AnaSpec, GenScript, CPC Scientific, company websites
GMP Requirements for Personalized Vaccines
- Each patient = unique batch with individualized release criteria
- ISO 7 cleanroom minimum (controlled environment for sterile manufacturing)
- Sterility testing — standard takes 2-3 weeks, a significant timeline bottleneck
- Chain-of-identity tracking (unlike mass-produced drugs, each batch maps to one patient)
- Validated analytical methods for peptide identity and purity (typically >95%)
How to Talk to Your Oncologist About This
Most oncologists are aware of personalized cancer vaccines as a research concept but may not know that patients can access them today through expanded access. Here are specific questions to bring to your next appointment:
"Has my tumor been genomically sequenced? If not, would whole exome sequencing be appropriate?"
Full WES is the foundation of personalized vaccine design. Many patients have had targeted panels (FoundationOne CDx) but not a complete exome.
"Based on my diagnosis and prognosis, would I be a candidate for FDA expanded access to a personalized neoantigen vaccine?"
Your oncologist can assess whether you meet the general criteria: no curative options, 12+ month life expectancy, ECOG 0-2.
"Are you aware of the Jaime Leandro Foundation's expanded access program for personalized peptide vaccines?"
JLF is the most established program. Your oncologist may want to review their FAQ at jaimeleandrofoundation.org/faqs.
"Would you be willing to file an individual patient IND application, or can you refer me to a physician who would?"
Any licensed physician can file. The simplified Form FDA 3926 is a single page. Some oncologists may prefer to refer to a colleague with expanded access experience.
"Are there any clinical trials for personalized cancer vaccines that I might qualify for?"
Clinical trials may be free or lower-cost than expanded access. Search at clinicaltrials.gov or ask your oncologist to check.
Disclaimer: This directory is for informational purposes only. ImmunaPath does not endorse, recommend, or have any business relationship with the labs, manufacturers, or organizations listed. Listing does not imply quality certification. Always verify credentials, availability, and current pricing directly with providers. All medical decisions should be made with your oncologist.
Last verified: March 2026. Provider information may change without notice.
Understand Your Options
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