Clinical Peptides

Clinical Peptides| cGMP Peptide Production | IND Filed Peptides | Clinical Trial Drugs | Science-Peptide

Need Clinical Peptides for IND filing or clinical trial? Science-Peptide provides Clinical Peptides cGMP manufacturing service, covering Phase I-III clinical samples, complying with FDA/EMA standards, 20 years experience, over 100 batches have been delivered. Welcome to contact us.

Why are Clinical Peptides requirements different?
Anyone who has done peptide drug development knows that even if you do well in the lab, it's another matter when you enter the clinic. Regulators are watching every detail - where the raw materials come from, how the process is controlled, how many impurities there are, and how stable the batches are.

 

Here's the difference between Clinical Peptides and Research Grade Peptides:
Research grade: just enough, mainly depends on the activity
Clinical use: every batch must be auditable, every piece of data must be traceable

Science-Peptide has been working in the field of Clinical Peptides for 20 years, and has helped clients through the whole process from IND filing to Phase III clinic. Currently, we have delivered more than 100 batches of clinical peptides, covering all stages from toxicology to process validation.

1. Covering the Full Clinical Development Cycle

2. The types of Clinical Peptides we can make

• Linear peptides: 2-50 amino acids, various lengths
• Cyclic peptides: first and last cyclization, side chain cyclization, disulfide bond cyclization
• Modified peptides: PEGylation, fatty acid modification, phosphorylation, acetylation
• Complex peptides: multiple pairs of disulfide bonds, stapled peptides, glycopeptides

3. CGMP Production Capacity

All facilities are FDA/EMA cGMP compliant, ISO certified and subject to customer audits.

4. The quality control system
Quality control of the whole process: intermediates, crude peptides, purified peptides, impurity profiles, each node is stuck

• Detection capabilities: HPLC, UPLC, MS, MS/MS, amino acid analysis, moisture, residual solvents, endotoxins, microorganisms, elemental impurities
• Stability studies: long-term, accelerated, influencing factors, support for expiry date development

1. 20 years of experience, over 100 clinical deliveries
Clinical peptides are not for everyone. We have been in the business for 20 years and have delivered over 100 batches of clinical peptides, covering all stages from IND enabling to Phase III. There are more than 10 APIs on the market - Atosiban, Terlipressin, Octreotide, Cetrorelix, etc., and each of them has gone through complete process validation and stability studies.

2. Process amplification: not simply replacing the bottle with a larger one
If you do well in a small test, the scale-up may not be smooth. The mixing efficiency changes, the heat and mass transfer is different, and the impurity profile may also change. We've suffered from scaling up, but we've also gained experience:

• Solid-phase amplification: Optimize resin selection, dosing ratio and washing method to ensure batch-to-batch reproducibility
• Liquid phase amplification: long peptides or hydrophobic peptides, liquid phase route is more economical, we specialize in designing hybridization routes
• QbD concept: Considering amplification factors at the development stage, identifying critical process parameters in advance

3. Impurity control, declaration of non-treading
What does Clinical Peptides fear most? An impurity profile that is not clear, or an impurity that is out of limits. We focus on impurities from the process development stage:

• Source analysis for each process impurity
• The key impurities are synthesized separately as controls
• Heterogeneous mass spectrometry and original research comparisons to ensure controllability

4. Filing documents, which help you to minimize the number of steps you have to take
Anyone who has ever done a clinical submission knows how annoying it can be to prepare the documentation. We can provide:

• DMF filing (authorized citation)
• Process validation report (program + results)
• Impurity profiling (process impurities + degradation impurities)
• Stability data (supports retest period setting)
• Change control and deviation management (in accordance with ICH Q10)
• These documents have helped many of our clients to successfully pass the FDA and EMA reviews.

5. Supply chain, so you don't get cut off
What's the biggest fear of making Clinical Peptides? Losing the raw materials while working on it. We:

• Dual sourcing: resins, amino acids, solvents, at least two qualified suppliers
• Strategic stockpiling: maintain safety stocks of commonly used materials
• Multi-base production: R&D, Pilot and Commercialization in three plants to diversify risks

6. Flexible forms of cooperation
Whether you're an innovative pharmaceutical or biotech company, we can:

• Early collaboration: process development + clinical samples, packaged pricing
• Post-transfer: assist technology transfer to your designated factory, or long-term OEM
• Filing support: cooperation with on-site audits, provision of documentation

Regardless of the stage of your project in IND filing or clinical trials, we can provide compliant, reliable and efficient Clinical Peptides manufacturing services.

I need you to tell me:
Peptide sequence or structure (signable NDA)
Current stage (IND, Phase I, Phase II, Phase III)
What services are needed (toxicology approvals, clinical approvals, validation approvals)
Batch size (grams or kilograms)
Special requirements (finishing, packaging, documentation)

When do you want it?

Give you a detailed proposal and quote within 24 hours.