One-Stop Product Development Support

From early R&D to clinical , we support each stage of your GMP peptide drug development,
ensuring consistent quality and compliance throughout your project's lifecycle.

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Peptide Grade Comparison

Understanding the difference between the GMP-grade and RUO-grade peptide attributes is crucial to your project’s success.
View the grade comparison chart:

SMALL & LARGE SCALES
CLASSICAL & COMPLEX

Peptide chemistry (cyclic, stapled, phosphorylated, biotinylated, fluorescent dye or quencher labeled or both for FRET/TR-FRET)

Attributes GMP Grade Research Grade
Quality Systems Controls 21 CFR parts 210 & 211 ISO 9001
Service Agreement Master Service Agreement, Quality Agreement Standard
Analytical Methods
Certificate of Analysis
Change Control Notification
Product Specification
Incoming Raw Material Specification & Testing
Expiry or Retest Date
Supplier Qualification
Identification of Critical Process Parameters
Batch Manufacturing Record & Review
Lot Sample Retained
Dedicated Project Management
Classified Clean Room ISO7 (10.000)
Validation Work

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Peptide modification experts

The optimization of peptides via synthetic modification, is crucial to the progression of novel peptide therapies,
peptide vaccines and peptide theranostics. Our expert team brings decades of experience in peptide synthesis
and purification of highly modified peptides. Our advanced techniques and state-of-the-art facilities
ensure precision and high quality in every modified sequence we produce.

Continuous training and staying updated with the latest advancements enable us to offer a range of modifications,
including cyclic peptides, chelation peptides, conjugated peptides, lipopeptides, glycosylated peptides, just to name a few.

Browse our modification list

Efficient Project Management

With our robust project management, we ensure timely and efficient delivery of your custom peptides. Our dedicated project managers work closely with you to understand your requirements, provide regular updates, and ensure that all milestones are met.

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Diverse Applications of GMP Peptides

AnaSpec manufactures GMP peptides for industries such as biopharma, biotech, diagnostics,
cosmetics, agro-food, and academia. These high-quality peptides are suitable for
preclinical studies and clinical use, or as critical raw material for biopharmaceutical applications.

Due to their potential for enhanced specificity and bioavailability compared to small molecules and large proteins, peptides are increasingly sought after by the biopharmaceutical industry and other sectors for the development of innovative peptide-based therapies.

Peptides currently play a crucial role in treating various conditions, including metabolic disorders, cancer, and infectious diseases, and rare diseases. Our GMP peptides are designed to meet the rigorous standards required for clinical use as API peptide drug substance, API precursors and excipients.

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In theranostics, GMP peptides are used for drug-targeting and payload delivery, often employed in radiopharmaceuticals for precise transport of imaging reagents.

In diagnostic assays GMP peptides serve as standards, controls, and reagents in mass spectrometry, immunoassays and other diagnostic techniques. Our high-quality GMP peptides ensure consistency and reliability for critical diagnostic applications.

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GMP peptides are integral to the development of peptide-based vaccines. They are used as antigens to stimulate the immune response and create immunity against various diseases. In personalized medicine, tumor specific epitope peptides called neoantigens can be employed to elicit an anti-tumor immune response.

Our GMP peptides support vaccine research and production, contributing to the advancement of safe and effective vaccines.

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The cosmetic industry utilizes GMP peptides for their beneficial effects on skin health and appearance. These peptides are included in formulations for anti-aging, skin repair, and hydration products.

Our GMP peptides ensure the safety and efficacy of cosmetic products, meeting the high standards of the industry.

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GMP peptides have applications in the development of bio-pesticides. These peptides contribute to sustainable agricultural practices by offering a natural and environmentally friendly alternative to traditional pesticides, improving crop protection, and reducing the reliance on chemical treatments.

GMP antimicrobial peptides (AMPs) have applications in veterinary medicine by acting as natural antibiotics in the treatment of infectious diseases.

Peptides are also being developed for a variety of other veterinary diseases including cancer, diabetes, and obesity.

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Why entrust AnaSpec with your GMP peptides?

One-Stop Provider

We offer a 5-in-1 solution, including GMP manufacturing, Analytical Method Validation, Stability Programs, CMC assistance for IND filing, and GLP study packages.

Small to Large Scale

Your request is important to us regardless of the production scale and we offer peptide quantities from a few milligrams to kilograms.

Fast Lead-Times

Quick delivery of peptide API for clinical use, emergency IND (EIND) use, API precursors and excipients, and other critical raw materials.

Quality Management

Comprehensive QMS global quality policy covers all company aspects from initial Sales, to Manufacturing, QA,QC, Shipping and beyond to ensure highest product quality and genuine excellence.

Transparent Communication

We provide fast, responsive, and transparent communication, with access to key team members. Client audits are always welcome.

Made
in the USA

Our multi-zone state-of-the-art facility headquartered in the heart of the silicon valley, houses all depts from Manufacturing, QA, QC testing, EH&S, Materials Management and beyond.

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