Peptide API Development
* Please kindly note that our products and services can only be used to support research purposes (Not for clinical use).
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Creative Peptides has been committed to custom peptide services and high quality products. With our expertise and advanced manufacturing facilities, we are passionate and confident in the development and production of peptide APIs, accelerating our global customers' drug discovery through our API development services, as well as providing high quality industrial scale products for viable projects.
Introduction
Peptides are present in all living organisms and play a key role in a variety of biological activities. Peptides have the inherent ability to block or enhance signaling in the body. When used as active pharmaceutical ingredients (APIs), peptides can treat various diseases such as metabolic diseases, tumors, cardiovascular and cardiac diseases, and neurodegenerative disorders.
The development of peptide APIs involves multiple peptide synthesis methods and requires state-of-the-art downstream processing (DSP) technologies to optimize peptide production and scale up to meet a wide range of customer needs. The key to mass production of peptide APIs is to achieve efficient conversion at each amino acid coupling to simplify the need for downstream purification, and to optimize process development to produce high purity custom peptides.
Peptide APIs have a variety of important applications in biochemistry, molecular biology, immunology and medicine, including peptide vaccines, tumor-targeting peptides, peptide ligands, cell-penetrating peptides, protein mimetics, and peptide supplements.
API Development Methods
Common methods for chemical synthesis of peptide APIs include solid-phase peptide synthesis (SPPS), liquid-phase peptide synthesis (LPPS), and fragment condensation. In addition, some peptide APIs are derived from microbial metabolism of active ingredients that can be produced by microbial fermentation through bioengineering technology.
Protected amino acid derivatives (e.g. Fmoc-, t-Boc-) are added successively to the growing peptide chain immobilized on the solid phase (resin), undergoing deprotection and washing steps to remove unreacted groups and by-products. The advantages of SPPS are easy purification, generation of long sequences of peptides, cost-effectiveness, and feasibility of a fully automated production process.
LPPS is used in the industrial production of peptides, allowing large-scale production of peptides and reducing the use of excess solvents, in line with the principles of green chemistry. LPPS has the advantage of allowing the deprotection and purification of intermediates and is commonly used in the synthesis of short peptides.
Fragment condensation
The fragment condensation method is an attractive option for synthesis of long peptides. Short fragments of the desired peptide are synthesized and then coupled together to form a long peptide.
Fermentation
Natural products from plants or microorganisms are a rich source of APIs. Naturally occurring antimicrobial peptides (AMPs) have attracted a lot of attention as potential antibiotics. The use of microbial cells as hosts for the production of bioactive peptides is a promising approach.
Advantages
- Alternative synthesis methods and optimized downstream processes
- Multiple synthesis conditions selection
- Short peptide, long peptide and complex modified-peptide synthesis
- High efficiency, cost saving, high yield
Quality Control
- cGMP compliant facilities and a quality management team
- Adequate impurity studies, including diastereoisomers and other relevant impurities
- Analysis method validation in accordance with ICHQ2, FDA, EDQM and NMPA
- Structure validation: comprehensive analysis of primary, secondary, tertiary and quaternary structures
- Quality standard development
- Control preparation, dispensing and calibration
- Stability studies
Capacity
- Process automation, improved process technology and increased capacity.
- Large-scale production, capable of hundreds of kilograms of peptide API manufacturing.
- Multi-step complex peptide synthesis, rigorous purification process.
- Strict control of process parameters for high batch-to-batch consistency.
- cGMP compliant facilities
- GMP analytical method development and validation
- Process control and lot documentation
- Process optimization
- Release specification design and testing
- GMP packaging
