cGMP Peptide Synthesis

GenScript Expands Peptide Production Capabilities to Include Neoantigen Peptides and APIs!

Support from Discovery to Clinical Trials

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.

FAQs

• What is cGMP Peptide?

  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.

• What is it used for?

  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.

• What is Genscript's offer for cGMP peptide?

  Neoantigen

  48 peptides/batch
  500 peptides/month
  Up to 150 mg/batch

  API

  800 g/batch
  Over 20 kg/year
  >30 Types Modifications

• What can GenScript support in cGMP peptide service?

  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

• Do you provide sterile products?

  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	/	/	✔	✔

• What modification can you provide?

  GenScript provide GMP-grade modified peptides, including cyclic peptides, peptide-drug conjugates (PDCs), etc.

• What QC do you provide for cGMP peptide?

  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

• what is the advantage of Genscript's GMP peptide

  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.

• Does neoantigen peptide need EMA or FDA approval?

  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.

• What is the difference between drug substance and drug product?

  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.

• Do you provide GMP-like? Pre-clinical?

  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.

• What is GenScript cGMP turnaround time? Any waiting period?

  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.

• How should I place an order for cGMP peptide?

  Please contact our sales account manager for assistant.

• What is the minimum quantity I can order? Maximum quantity?

  There is no minimum quantity for each order. For specific pricing and quantity range information, please contact our sales account manager.

Resources

White Paper - Synthetic Peptides in Cancer Immunotherapy Development

Significant discovery efforts precede the selection of neoantigens in support of adoptive T-cell therapy or vaccine development.

Free Download