Learn important facts about Peptide Quality & Purity

Peptide Quality & Purity

1. Peptide Purity

JPT's Peptide Purity Grades for immunology products

Fast Grade

Fast Plus Grade

Research Grade

Research Plus Grade

Development Grade

Trial Grade

Premium Grade

Clinical Grade*

Purity

unpurified (crude)

each peptide is detectable

each peptide is guaranteed to be the main product

each peptide is purified to > 70%

each peptide is purified to > 80%>90% or>95%

each peptide is purified to >90%

each peptide is purified to >90% or>95%

Example applications

T cell epitope discovery, target discovery

neo-epitope prioritization, target identification, screening

T cell epitope discovery, immunogenicity testing, identification of immunodominant antigens

T cell epitope discovery, target identification, screening

immune monitoring, T cell epitope mapping

immune monitoring in trials, vaccine development

clinical and translational research

clinical immune monitoring, diagnostics and therapy development

QC

statistical HPLC-MS (5% of all peptides)

HPLC/MS of each peptide

HPLC-MS of each peptide + recurrent performance testing (ELISpot) + cytotox, endotoxin & sterility testing -> new CoA after each test

HPLC/MS of each peptide+ further QC and documentation

Synthesis method

high-throughput SPOT synthesis

resin-based peptide synthesis

Related products

PepTrack Fast TrackSpotMix

PepTrack Fast Track PlusSpotMix Plus

PepTrack Research Track

PepTrack Research Track PlusPepMix Research Plus Grade

PepTrack Development TrackPepMix Development Grade

PepTrack Trial TrackPepMix Trial Grade Antigen Peptides

CEFX Pool Premium GradeCEFT Pool Premimum GradePepMix CMV (pp65) Premium Grade

Clinical Peptides & Pools

* Clinical Grade Peptides are synthesized in an enhanced peptide synthesis environment including a variety of quality features required for clinical peptide applications.

2. Peptide Quality Measures Beyond Purity

Animal-derived component free (ADCF)

Equipment which has not been exposed to animal-derived materials or has been decontaminated

Use of non-animal derived raw materials

Manufacturing takes place in laboratories where no materials of animal origin are stored and used

Other components, tools and processes used to decrease the risk for contaminating peptides

Non-peptide impurities

TFA Content & Counter Ion Exchange

Risk

Counter measure

Decomposition of peptides

Post counter ion exchange peptide analysis is mandatory for each peptide (i.e. by HPLC-MS) as partial decomposition may occur

Counter ion exchange is sequence dependent

Apply optimized and peptide sequence-specific protocols

Incomplete ion exchange

Determine residual TFA quantitatively after exchange for each peptide

Difficult Peptides

Strong hydrophobicity

Secondary structure propensity

Spontaneous re-arrangement and oxidation reactions

Hydrolysis and peptide bond cleavage

Loss of stereomeric integrity

Remaining protecting group artifacts

Several more

Average Purity

Peptide Pool Analysis

Manufacturability Algorithm

Line clearance

Low Bioburden Manufacturing Processes

Established pest control and hygienic program

Cleaning procedures prior to specific process steps during the manufacturing of ISO PLUS and CGP products

Advanced protective clothing such as mask, hairnet and gloves for high risk processes such as final weighing steps during the manufacturing of CGP products

Filtering processes to remove large particles after the peptide purification process during the manufacturing of CGP products

Peptide pooling and aliquotation are performed in sterile workbenches for CGP products

Capping

Recurrent Performance Testing

Assay standardization & validation

Minimized performance variability

Updated Certificate of analysis (CoA)

Cytotox Testing

Endotoxin Testing

Sterility Testing

3. Quality Management System