Custom GMP Manufacturing
GMP Peptide
Manufacturing Services
We specialize in the manufacture of GMP peptides, with a focus on
complex-modified peptides and peptidomimetics. Discover how our decades of
industry expertise, rigorous quality management system, and state-of-the-art facilities,
can be leveraged to deliver peptides according to your unique requirements.
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.
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 | ✓ | |
CMC Package for IND submission
AnaSpec offers a Chemistry, Manufacturing and Control (CMC) package as required for IND application. The CMC package includes stability program, purity method development (includes forced degradation studies to establish Stability indicating Method) as well as phase appropriate validation per applicable ICH guidelines suited for products intended use.
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.
Modifications at a glance
Conjugated
- Chelation Peptides
- Drug-Peptide Conjugates
- Peptide-Oligo Conjugates
- Carrier Protein Conjugates
Structural
- Lactam ring cyclic peptides
- Disulfide-bridged peptides
- Stapled peptides
- Thioether-bridged peptide
- Thiolactone cyclization
State-of-the-Art Manufacturing Facilities
Our cutting-edge manufacturing facilities are designed to support the production of high-quality GMP peptides.
Spanning 44,000 square feet in California’s Silicon Valley, our headquarters include dedicated, multi-zoned areas for manufacturing, QA, QC, packaging, and shipping. Equipped with state-of-the-art manufacturing equipment, our facilities include highly controlled ISO 7 classified cleanroom environments, to ensure the integrity and quality of every peptide we produce.
We follow strict GMP guidelines, with features including restricted airlock entry, rigorous environmental monitoring, complete segregation of downstream from upstream processing, and line clearance procedures.
Solid Quality Assurance
AnaSpec adheres to stringent GMP standards. Our dedicated QA department oversees the global quality management system, continuously updating staff on the latest QA practices and regulatory requirements to ensure ongoing compliance and excellence. We regularly undergo thorough audits and inspections to maintain compliance and uphold our commitment to quality.
Our comprehensive Quality Management System (QMS) adheres to 21 CFR 210 and 211 as well as ICH Q7 guidelines suited for products intended use. Each peptide we produce undergoes rigorous testing to ensure purity, quality, integrity and consistency. FDA FEI Number : 3001419809
PSC Biotech has verified our compliance to produce GMP peptides.
Key Elements of our QMS
- Regulatory Compliance: We follow GMP standards and undergo regular audits to ensure quality.
- Raw Material Control: We verify the quality of starting materials and qualify suppliers.
- In-Process Control: Robust controls during production ensure our products meet specifications.
- Quality Control: We use qualified analytical methods to verify peptide quality.
- Stability Testing: Stability samples are maintained and monitored in validated storage chambers, upon request.
- Documented Process: Our GMP manufacturing process is meticulously documented and archived for five years, with redacted records available for transparency.
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.
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.
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.
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.
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.
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.
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.
