Peptide API Development

* Please kindly note that our products and services can only be used to support research purposes (Not for clinical use).

Online Inquiry

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

Peptide API Development

Synthesis

  • 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
Peptide API Development

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
Peptide API Development

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.
Peptide API Development

cGMP Manufacuring

  • cGMP compliant facilities
  • GMP analytical method development and validation
  • Process control and lot documentation
  • Process optimization
  • Release specification design and testing
  • GMP packaging
If you have any peptide synthesis requirement in mind, please do not hesitate to contact us at . We will endeavor to provide highly satisfying products and services.

Customer Support & Price Inquiry

Resource

Creative Peptides is a custom lab chemical supplier that provides a wide range of peptides for the pharmaceutical and biotechnology industries.

Learn More

Effects of L-NMMA Acetate in DOCA-salt Hypertension

 NG-monomethyl-L-arginine (L-NMMA) acetate, a structural analogue of L-arginine, also named tilarginine acetate a ...

Delcasertib: A Novel δ-Protein Kinase C Inhibitor

  Delcasertib, also known as KAI-9803, is a 23-amino acid peptide and δ-protein kinase C (δ-PKC) inhibitor. KAI-9 ...

The effect of taltirelin in delayed neuronal death

 Taltirelin is a thyrotropin-releasing hormone (TRH) analog that binds the brain BRH receptors in vivo. Taltireli ...

Function of teriparatide in the treatment of osteoporosis

 Teriparatide is a human parathyroid hormone analog with the same structure as the N-terminal 34 amino acid seque ...

Function of Norleual in Pancreatic Cancer

 Norleual is a potent inhibitor of the HGF/Met system, which inhibited the prosurvival effects of HGF and suppres ...

Contact Us

Address:

Tel: |

Email:

Copyright © 2022 Creative Peptides. All rights reserved.