GMP Grade Peptide Manufacturing | cGMP Peptide Manufacturing | Clinical Peptide Supply | Science-Peptide
Need GMP grade peptide for clinical trial or commercialization? Science-Peptide provides GMP Grade Peptide Manufacturing service, which is compliant with FDA/EMA cGMP standard, and supports IND filing to commercial supply. 20 years of experience, and over 100 batches of peptide for clinical use have been delivered. Welcome to contact us.
Your peptide's going into the clinic? GMP manufacturing is the next hurdle
Why do we need to consider GMP production now?
At this stage of the project, you may ask: the research grade peptide we used before is quite good, why do we have to do GMP Grade Peptide Manufacturing?
The difference is simple: research-grade peptides are for "discovery", while GMP-grade peptides are for "people". Once your peptide is ready to be used in a clinical trial, regulators will be watching every detail - where the raw materials come from, how the process is controlled, how many impurities are present, and how stable the batch is. These are not questions that research-grade peptides can answer.
The core of GMP Grade Peptide Manufacturing is to ensure that every batch of peptide produced is safe, effective and of consistent quality with a system that can withstand audits. We have accompanied many of our customers along the path from IND filing to Phase III clinical trials to commercialization.
Our GMP manufacturing facility
Science-Peptide is equipped with specialized production platforms for all stages of peptide drug development:
|
Facilities |
Area |
Function |
|
Research and Development Center |
1200㎡ |
process development, analytical method validation, preclinical sample preparation |
|
GMP pilot site |
4800㎡ |
4 independent production lines to support production of Phase I-III clinical samples (1-50 kg/batch) |
|
cGMP API plants |
10 acres |
Commercial scale production, solid-phase synthesis kettle up to 5000L, liquid-phase reaction kettle up to 3000L |
All facilities are designed and operated in accordance with FDA/EMA cGMP standards, are internationally ISO certified, and are subject to regular client audits.
Our GMP Grade Peptide Manufacturing Capabilities
|
Project |
Capacity |
|
scale of production |
Grams to hundred kilograms (scalable to tons) |
|
Synthesis platforms |
solid-phase synthesis (SPPS), liquid-phase synthesis (LPPS), solid-liquid hybridization |
|
Amino acid length |
2-40 amino acids |
|
modification capabilities |
GMP level modifications (PEGylation, fatty acid modification, disulfide bonding, etc.) can be undertaken. |
|
purity range |
Customized, up to 99.5% or more |
|
compliance standards |
cGMP(FDA/EMA),ICH Q7,ISO9001 |
|
The documentation system |
DMF filings, process validation reports, stability data, impurity profiling |
Why Choose GMP Grade Peptide Manufacturing from Kepin Bio?
Why choose Science-Peptide's GMP Grade Peptide Manufacturing?
1. Extensive experience in GMP production, having delivered more than 100 batches
We have successfully completed more than 100 batches of GMP Grade Peptide Manufacturing projects, covering all stages from IND enabling to commercialization. We have marketed more than 10 APIs, including Atosiban, Terlipressin, Octreotide, Cetrorelix, etc., each of which has undergone complete process validation and stability studies.
2. Whole process quality by design (QbD)
At the process development stage, we introduced the QbD concept to identify critical process parameters (CPP) and critical quality attributes (CQA) to ensure robust scale-up. Even in the early clinical stage, we reserve space for subsequent commercial scale-up to minimize the risk of late-stage process changes.
3. Strict quality control system with batch traceability
- Whole process quality control: intermediate detection, crude peptide purity, purity after purification, impurity profile analysis.
- Detection Capability:HPLC, UPLC, MS, MS/MS, Amino Acid Analysis, Moisture, Residual Solvent, Endotoxin, Microbial Limit, Elemental Impurities, etc.
- Stability studies: long-term, accelerated, impact factor tests to support expiration date development.
4. Complete regulatory documentation support, global declaration without worry
We provide a complete set of documents that meet the US FDA/European EMA filing requirements:
- DMF filing (can be cited under customer authorization)
- Process validation report (with process description, validation program and results)
- Impurity profiling (covering process impurities, degradation impurities)
- Stability data (supports retest period and expiration date settings)
- Change control and deviation management (in accordance with ICH Q10)
5. Security of the supply chain, without fear of disruption
- Dual-source procurement: at least two qualified suppliers for key materials (resins, amino acids, solvents).
- Strategic stockpiling: Maintain safety stocks of commonly used materials to cope with unexpected demands.
- Multi-base production: R&D, pilot plant and commercialization are distributed in three independent plants to diversify risks.
6. Flexible models of cooperation, accompanied by services
Whether you are an innovative pharmaceutical company, a biotech company, or a generic company, we offer flexible collaboration options depending on the stage of your project:
- Early cooperation: process development + clinical sample production, package pricing.
- Post-transfer: We can assist in technology transfer to your designated factories, or long-term OEM production.
- Filing support: cooperate with on-site audits and provide required documentation.
What Conditions Require GMP Grade Peptide Manufacturing?
|
Stage |
Dem |
What we can do |
|
IND declaration |
GLP/GMP compliant toxicology lot and clinical lot samples are required |
Rapid enlargement, provision of full set of filing documents |
|
Clinical Phase I/II |
Need multiple batches of GMP material, explore dosage |
Multi-batch production, robust process, controlled impurity profile |
|
Clinical Phase III |
Requires a process validation lot to confirm the commercialization of the process |
Process validation (PPQ), stability studies |
|
commercialization listing |
Need for continuous supply, cost optimization |
Process optimization, dual-source guaranteed supply, long-term cooperation |
|
generic drug development |
Reverse engineering is required to develop compliant processes |
Heterogeneous mass spectrometry against the original, declared support |
Delivery and support
Delivery form: aseptic bag/drum, can be packaged according to customer's requirements (such as special lining, nitrogen protection).
Accompanying documents: COA (with purity, impurities, residual solvents, etc.), process validation report (negotiable), stability summary (optional).
Regulatory support: provide a full set of documents required for filing, and cooperate with on-site audits.
Technology transfer: We can assist in transferring the process to the customer's designated factory, or provide long-term OEM service.
Real-life examples: from IND to commercialization, all the way to accompaniment
Case 1: Late clinical supply of innovative pharmaceutical companies
A domestic innovative pharmaceutical company is developing a peptide drug, ready to enter the phase III clinic, and needs 20 kilograms of GMP-grade materials. By utilizing our existing solid phase synthesis platform, we completed the process scale-up and 3 batches of GMP production in 4 months, with purity >98% and monohybrid <0.5% in all batches. The customer has successfully submitted NDA and has been approved for marketing, and we continue to supply API for commercialization.
Case 2: DMF filing support for overseas pharmaceutical companies
A European pharmaceutical company plans to file its peptide API in China and needs DMF support from a local cGMP manufacturer. We prepared the DMF document according to ICH M4 format and authorized the client to quote it in the filing. The client successfully obtained approval and we became an important part of its supply chain in Asia.
Case 3: "Firefighters" in emergency supply shortages
A multinational pharmaceutical company's marketed peptide API, the original supplier stopped production due to environmental issues, facing a global supply shortage. We received an urgent order to deliver 100 kg of API within 6 months, and we mobilized two lines of solid-phase and liquid-phase production in parallel, and finally delivered the product 2 weeks ahead of schedule, helping the customer to avoid shortage in the market.
Now, what about your GMP production needs?
Regardless of the stage of your project - IND filing, clinical trial, or commercialization - we can provide you with compliant, reliable, and efficient GMP Grade Peptide Manufacturing services.
Please tell us:
Peptide Sequence or Structure (Signable NDA Confidential)
current stage and required lot size
Quality requirements (purity, impurity limits, etc.)
Special needs (e.g., grooming, packaging, documentation)
Give you a professional feasibility assessment and quote within 24 hours.
