Peptide API Services
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Our peptide API process development and manufacturing platform provides an end-to-end solution from preclinical to commercial stages. We have built industry-leading capabilities and capacities to support your needs across all development stages, ensuring knowledge retention throughout the product lifecycle.
For peptide API process development, we have experienced R&D teams, equipped with state-of-the-art equipment and instruments. Together with our small molecule team, we extend capability to peptide conjugates and building blocks.
Comprehensive Peptide Process Development Capability
We possess extensive experience in a wide range of peptide process development, including:
- Linear Peptide
- Cyclic Peptide
- Modified Peptide
- Capability of Solid Phase and Liquid Phase Chemistry
- Experienced in peptide conjugation such as Peptide-PMO (PPMO) and peptide-toxin
Manufacturing Capacity
With our global standard quality system, we are well positioned to be your strategic manufacturing partner for reliable and robust supplies of your peptide APIs, from gram to metric ton scales. Our custom synthesizers and cleavage systems are designed to minimize risks of both microbial contamination and cross-contamination. Our unique ‘one-site’ platform ensures knowledge retention and scale-up throughout your product life cycle, while expediting your development through seamless collaboration among different functional teams.
At our Changzhou and Taixing sites in China, we have over 20 production lines with a wide range of synthesizers from 20 L to 3,000 L, including:
- 1,000 L reactors
- 2,000 L reactors
- 3,000 L reactors
Till now, the overall Solid Phase Peptide Synthesis (SPPS) total reactor volume is 32,000+ L.
Access to New Technologies
Liquid Phase Peptide Synthesis
Biocatalysis
Continuous Purification
UF/DF
Spray Dried Dispersion
Precipitation
Liquid Phase Peptide Synthesis
Biocatalysis
Continuous Purification
UF/DF
Spray Dried Dispersion
Precipitation
Liquid Phase Peptide Synthesis (LPPS)
- Route design and protection strategy selection for a wide range of peptides
- Quality by design(QbD) to support LPPS process performance qualification
- Our dedicated process crystallization team can circumvent most pre-HPLC separations.
- LPPS and SPPS combined approach for complex peptides synthesis
- Both batch mode and flow mode
- Hydrogenation capable
Unnatural Amino Acid
We are experts in producing 2,500+ unnatural amino acid catalog products, including the most complex structures, tailored to our customers’ specifications from kilo to metric ton scales. Upholding global quality standards, we develop robust processes for amino acid products, guaranteeing superior quality.
Visit Amino Acid e-Shop
Leveraging the knowledge and synthetic expertise of our seasoned chemists, we also offer custom amino acid synthesis services. If your desired structure is not on our list, or you require a bulk order, we are readily available to assist.
α-Me-amino acids:
- We utilize the natural amino acid Alanine to design α-Me-amino acid derivatives. This methodology can be extended to other natural amino acids, such as Leucine, Phenylalanine, etc.
N-Me-amino acids:
- We have developed a cyclization process that allows methylation to be achieved in just two steps.
PG series:
- All protecting strategies, including Boc, Fmoc, Cbz, Mtt, DDE, and IVDDE, can be implemented.
α- and β- construction series:
- We have developed enzyme catalyst techniques to construct selectable α- or β-site unnatural amino acids.
NCA series:
- We have developed a process to effectively control the quality of NCAs.
Peptide Conjugate
Peptide conjugation is a rapidly expanding field, serving as a new modality for targeted drug delivery. This technique enhances efficacy and reduces side effects in cancer treatment. Our comprehensive peptide platform, combined with our small molecule chemistry capability, provides a one-stop solution for peptide conjugate development and manufacturing. We support various peptide conjugates including but not limited to: Peptide-PMO, Peptide-Oligonucleotide, Peptide-Toxin.
- Design linkers with optimal size, suitable release mechanism and compatible conjugation chemistry
- Develop payload derivatives with modified toxicity and/or special linkage site
- Synthesize customized drug-linker complexes
- Seamless scale up from discovery to commercial
- Sample payload in stock: MMAE, MMAF, DM1, DM4, PBD, Doxorubicine derivatives etc
- Sample linkers in stock: MC-VC-PAB-PNP, Glu-VC-PAB, NHS-Glu-VC-PAB, Azido-Glu-VC-PAB, Hydrazone (acid Sensitive), Disulfide (Glutathione sensitive), SMCC etc
Samples of 350+ Linkers
Samples of 40+ Payload Modifications
Case Study: Our Integrated Peptide-toxin Development and Manufacturing Service Saved 4-6 Months
- Seamless collaboration with in-parallel activities across 4 workstreams
- Swift sample transport and information sharing from upstream to downstream teams
Related Resources
Empowering Highly Potent Peptide Drug Conjugate Scale-up with Flow Chemistry
Peptide API & Drug Product Facility Virtual Tour
