Large Scale Peptides | kilogram peptides | cGMP peptide synthesis | Science-Peptide
Meta Description
Need peptides over kilograms in size? Science-Peptide's Large Scale Peptides service covers from process development to cGMP production, with a dual platform of solid phase/liquid phase. Please feel free to inquire.
Your peptide going to the clinic or market? We'll scale up production
Why do you need Large Scale Peptides?
When your peptide project from the laboratory to the clinic, or even ready to go to market, the need is no longer milligrams of samples, but kilograms, hundred kilograms of API. At this time, the question arises: can the small test process be scaled up smoothly? Can the cost be controlled? Can the quality be stabilized, and can the GMP compliance meet the global declaration?
Science-Peptide's Large Scale Peptides service is designed for this stage. We have 20 years of experience in peptide production, driven by dual platforms of solid-phase and liquid-phase synthesis, from process development to commercialization. Purity, yield and cost are all well tested.
Why choose our Large Scale Peptides?
1. Process amplification: not simply replacing the bottle with a larger one
If you do well in the 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 change. We have accumulated enough lessons and experience in scale-up:
Solid Phase Synthesis Scale-up: From grams to kilograms, we have optimized resin selection, feed ratios, and washing methods to ensure batch-to-batch reproducibility.
Scale-up by liquid phase synthesis: For long or hydrophobic peptides, liquid phase routes are often more economical. We specialize in designing liquid/solid phase hybrid routes that balance cost and purity.
Quality by Design (QbD): Considering scale-up factors during the process development phase, identifying critical process parameters in advance and reducing risks at a later stage.
2. cGMP compliance: meets global reporting requirements
Our production sites:
GMP pilot plant (4800 square meters): 4 independent production lines to support the production of clinical phase I-III samples.
cGMP API plant (10 acres): Fully compliant with ICH guidelines and ISO certified.
Documentation system: Provide DMF filing information that meets the requirements of U.S. FDA/European EMA, and support customers to register globally.
3. Flexible capacity for Large Scale Peptides: from kilograms to hundred kilograms to tons
R&D Center (1200㎡): Rapid process development, milligrams to hundred grams.
Pilot plant: 1-50 kilograms to meet the needs of clinical samples.
Commercial production: 50 kg to hundreds of kilograms, scalable to tons.
Multiple production lines: solid-phase synthesis kettle (max. 5000L), liquid-phase reaction kettle (max. 3000L), parallel production of multiple projects.
4. Strict quality control, 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, etc.
Stability studies: long-term, accelerated, impact factor tests to support expiration date development.
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 Stocks: Maintain safety stocks of commonly used materials.
Multi-base production: R&D, pilot plant and commercialization are distributed in three independent plants to diversify risks.
An Overview of Our Large Scale Peptides 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 |
2-189 amino acids |
|
Modification support |
Can articulate large-scale modifications (PEGylation, fatty acid modification, etc.) |
|
Purity range |
Customized, up to 99% or more |
|
Compliance standards |
cGMP (FDA/EMA standard), ISO9001 |
|
Documentation support |
DMF filings, process validation reports, stability data |
What Large Scale Peptides Situations Require Large Scale Peptide Synthesis?
|
Stage |
Dem |
What we can do |
|
Preclinical toxicology studies |
Need kilogram samples for GLP toxicology |
Rapid scale-up to provide GLP-compliant materials |
|
Clinical phases I-III |
High batch-to-batch consistency requires cGMP production |
Multi-batch production, robust process, controlled impurity profile |
|
Commercialization listing |
Hundred-kilogram API supply, cost-optimized |
Process optimization, liquid-phase route for cost reduction, dual-source supply |
|
Secondary development of listed APIs |
need to substitute suppliers or optimize processes |
Reverse engineering to develop more cost-effective routes |
Delivery and Support
Delivery form: aseptic bag/drum, can be packaged according to customer's requirement.
Accompanying documents: COA (with purity, impurities, residual solvents, etc.), synthesis report, stability summary (optional), process validation report (negotiable).
Regulatory support: provide a full set of documents required for filing, and cooperate with on-site audits.
Real-life example: the leap from grams to hundred kilograms
Case 1: The localization and substitution of API in a European pharmaceutical company
The peptide API used by the customer for the original drug development came from a European supplier with high cost and long delivery time. After we took over the business, we first synthesized gram-scale samples in the R&D center to confirm the quality consistency; then we completed 3 batches of process validation in the pilot plant (each batch of 10 kg), and the purity was comparable to that of the original research, with better impurity profiles; finally, we scaled up to a commercial batch of 50 kg/batch, which reduced the cost by 40%, and became the designated supplier in the global supply chain of the customer.
Case 2: Late clinical supply of innovative domestic pharmaceutical companies
The customer has developed a peptide drug, ready to enter the phase III clinic, and needs 20 kg of GMP grade material. By utilizing our existing solid phase synthesis platform, we completed the process scale-up and 3 batches of GMP production in only 4 months, and all batches were >98% pure with <0.5% single impurity. The customer has successfully submitted IND, and the product has been approved for marketing.
Case 3: "Firefighters" in emergency supply shortages
A multinational pharmaceutical company's marketed peptide API, the original supplier shut down production due to environmental issues, the market is facing a shortage of supply, we received an urgent order, need to deliver 100 kilograms of API within 6 months. We received an urgent order to deliver 100kg 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, which helped the customer to avoid shortage in the market.
Now, what about your mass production needs?
If you have a peptide project that needs to be scaled up, no matter at what stage, you can contact us. Tell us your sequence, target size, and quality requirements, and get a preliminary feasibility assessment and quote within 24 hours.
