cGMP is not a type of peptide, such as a cyclic peptide. Instead, it is a regulatory standard for manufacturing and controlling peptides, especially when they are intended for specific stages like clinical trials.
20+ Years Expertise
cGMP Compliance
Regulatory support
cGMP manufacturing opened 2023
One stop service, provide API manufacturing process development to regulatory compliance for IND application
Clean suite with Grade A isolator for sterile peptide
Sterilization filtration and aseptic filling for neoantigen
Process development and scale-up competence
Delivers up to 48 personalized neoantigen sequences/patient/batch, enabling rapid manufacturing, QC, and release.
Complex sequences and peptide modifications adapted to large scale production, including cyclic peptides and peptide-drug conjugates.
Traceable and comprehensive batch production records
Identity, purity, bioburden, endotoxin, etc. for releasing specification
Material supplier management
Analytical method development, verification and validation
Long-term stability study, accelerated stability study and stress condition studies compliance with ICH guidance
Phase-appropriate GMP implemented and documented
TSE/BSE statement
GenScript offers the manufacturing expertise, capacity, and validated platform processes to accelerate your neoantigen and API peptide from early drug discovery to the clinic Phase I/II study. Our complete suite of phase-appropriate cGMP facilities and one-stop service provide the flexibility to support your project at all stages.
cGMP is not a type of peptide, such as a cyclic peptide. Instead, it is a regulatory standard for manufacturing and controlling peptides, especially when they are intended for specific stages like clinical trials.
cGMP is required for peptide drugs when they progress to human clinical trials. However, GMP is not essential during the drug discovery or preclinical studies stages.
Neoantigen
48 peptides/batch
500 peptides/month
Up to 150 mg/batch
API
800 g/batch
Over 20 kg/year
>30 Types Modifications
Support from peptide API CMC to IND enabling, clinical trials and NDA/commercial
cGMP-compliant facilities
Meets ICH Q7 and 21 CFR 210/211 guidelines
Clean suite with Grade A isolator in Grade C background
Regulatory strategy for peptide drug substance or drug product
When the client requests a final injectable drug product, it must be sterile. However, when discussing the peptide active pharmaceutical ingredient (API), sterility is not needed during manufacturing, as a sterilization step will be employed to ensure the final drug product is sterile. In one scenario, sterility is required for the peptide itself, specifically the neoantigen used for peptide vaccine. GenScript's sterile filtration and aseptic fill/finish facility will begin operations in Q2 2024
| Peptide Vaccine | ||||
|---|---|---|---|---|
| Research Milestone | R&D | IIT | IND | Clinical |
| Production environment | RUO | Grade C environment | Grade C environment /GMP | GMP |
| Identification | MS | MS | MS | MS |
| Purity | ≥95% | ≥95% | ≥95% | ≥95% |
| Residual solvent | / | Δ | ICH Q3C | ICH Q3C |
| Counter ion content | / | / | ≤10% | ≤10% |
| TFA content | ≤1% | ≤1% | ≤1% | ≤1% |
| Water | / | / | ≤10% | ≤10% |
| Bacterial endotoxin | <10 EU/mg | <10 EU/mg | <10 EU/mg | <10 EU/mg |
| Microbial limit | / | TAMC≤ 200 CFU/g TYMC≤ 50 CFU/g |
TAMC≤200 cfu/g TYMC≤50 cfu/g |
TAMC≤200 cfu/g TYMC≤50 cfu/g |
| Sterility | / | / | Δ | Δ |
| Peptide content | / | ≥70% | ≥70% | ≥70% |
| CMC study | / | / | ✔ | ✔ |
Δ: Optional
| DC Vaccine | ||||
|---|---|---|---|---|
| Research Milestone | R&D | IIT | IND | Clinical |
| Production environment | RUO | RUO/ Grade C environment | RUO/ Grade C environment | Grade C environment /GMP |
| Identification | MS | MS | MS | MS |
| Purity | ≥90% | ≥90% | ≥95% | ≥95% |
| Residual solvent | / | / | ICH Q3C | ICH Q3C |
| Counter ion content | / | / | ≤20% | ≤20% |
| TFA content | ≤1% | ≤1% | ≤1% | ≤1% |
| Water | / | / | ≤10% | ≤10% |
| Bacterial endotoxin | <10 EU/mg | <10 EU/mg | <10 EU/mg | <10 EU/mg |
| Microbial limit | / | TAMC≤5 cfu/mg | TAMC≤5 cfu/mg | TAMC≤5 cfu/mg |
| Sterility | / | / | / | / |
| Peptide content | / | / | ≥70% | ≥70% |
| CMC study | / | / | ✔ | ✔ |
GenScript provide GMP-grade modified peptides, including cyclic peptides, peptide-drug conjugates (PDCs), etc.
GenScript can provide customized QC test items for neoantigens, as shown in the recommended specifications table.
For peptide drugs, the testing items may vary for each product at different stages, with different testing items for the preclinical and clinical stages. When advancing to the New Drug Application (NDA) stage, a solid specification can be established.
| Quality Attribute | Acceptance Criteria | Method Reference |
|---|---|---|
| Appearance | White to off-white solid | Visual Inspection |
| Molecular Weight | Consistent with calculated molecular weigh | USP <736>, MS |
| Identification | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay | USP <621>, HPLC |
| Purity | 95% specific to different sequences | USP <621>, HPLC |
| Related substances | Report result | HPLC |
| Ion Content（ TFA、Acetic acid） | TBD | USP <503> <1065>, HPLC/IC |
| Solubility | Report result | Visual Inspection |
| Water content | Not more than 10% | USP <921>, Karl Fischer |
| Residual Solvents | Comply with ICH Q3C | GC |
| Elemental impurities | Comply with ICH Q3D | ICP-MS |
| Microbial limit | TAMC: NMT 200 CFU/g TYMC: NMT 50 CFU/g |
USP <61> <62> |
| Endotoxin | NMT 10EU/mg
TYMC: NMT 50 CFU/g |
USP <85>, Gel-clot method |
| Sterility | Sterile | USP <71>, Membrane Filtration |
We have an individual production line for neoantigen peptide, which can guarantee the products quality and also shorten the waiting time. For API peptide, we are able to provide complex peptide including cyclic peptide, peptide drug conjugate and etc.
At GenScript, we provide neoantigens to our clients. However, approval from regulatory agencies such as the EMA or FDA is required before clinical trials can commence and before our clients' final drug product can be commercialized.
Drug Substance (Active Pharmaceutical Ingredient, API) refers to an active ingredient intended for incorporation into a finished dosage form, meeting the statutory definition of a drug that is intended to provide pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the human body.
Drug Product, on the other hand, is a finished dosage form (such as a tablet, capsule, solution, or injection) containing a drug substance, generally but not necessarily in association with one or more other ingredients.
We can provide phase-appropriate quality management for neoantigens. Additionally, for peptide APIs, if the client's peptide drug is in the preclinical or IND-enabling stage, full GMP may not be required, but we can still provide phase-appropriate quality management.
Neoantigen peptide projects typically take 30-40 days, with no waiting period once confirmed, and the project is initiated immediately.
For peptide API projects, the process begins with lab-scale process development, followed by pilot-scale production, and then transition to GMP manufacturing. This project involves several milestones, and the timeline for each milestone depends on the complexity of the client's peptide and the progress made by our clients.
Please contact our sales account manager for assistant.
There is no minimum quantity for each order. For specific pricing and quantity range information, please contact our sales account manager.
Significant discovery efforts precede the selection of neoantigens in support of adoptive T-cell therapy or vaccine development.
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