Last updated: August 6, 2025
Introduction
China patent CN107531667, titled "Method for producing a high-purity peptide," emerges within the domain of peptide synthesis, with particular emphasis on manufacturing techniques conducive to high-purity outputs suitable for pharmaceutical applications. This patent reflects China's strategic focus on advancing biopharmaceutical manufacturing processes, aligning with global trends towards biologics and peptide therapeutics. This analysis delves into the scope and claims of CN107531667, examining their technological coverage and implications within the broader Chinese and international patent landscapes.
Patent Overview
Publication Details:
- Patent Number: CN107531667
- Filing Date: December 24, 2015
- Publication Date: April 28, 2017
- Assignee: [Assignee details typically disclosed in full patent text; presumed to be a biopharmaceutical or biotech entity]
- Technical Field: Peptide synthesis, purification, and pharmaceutical manufacturing
Abstract Summary:
The patent discloses a novel method for synthesizing high-purity peptides involving specific steps of solid-phase synthesis, purification, and quality control. The invention aims to improve yield, reduce impurities, and streamline manufacturing, applicable to pharmaceutical-grade peptides.
Scope of the Patent
The patent claims focus on a comprehensive process for peptide production that emphasizes purity, efficiency, and scalability. The scope encompasses:
- Synthesis Technique: Specifically, an optimized solid-phase peptide synthesis (SPPS) protocol. The method reportedly introduces a unique resin or linker to improve peptide chain elongation and fidelity.
- Purification Process: Includes a multi-step purification involving chromatographic techniques such as high-performance liquid chromatography (HPLC), possibly combined with selective precipitation or filtration steps targeting impurity removal.
- Quality Control Measures: Embeds specific parameters for assessing purity levels, including mass spectrometry and amino acid analysis, ensuring the peptide meets pharmaceutical standards.
The claims' scope suggests a process patent with specific process steps, reagents, and apparatus configurations designed to minimize impurities—particularly racemization, deletion sequences, or side-products common in peptide synthesis.
Claims Analysis
Claim 1: Independent Core Claim
The primary claim of CN107531667 delineates a method comprising:
- Solid-phase peptide synthesis utilizing a specific resin and linker designed to enhance the yield and purity.
- Stepwise chain elongation under controlled conditions, with particular reagents and catalysts specified.
- Sequential purification, involving chromatographic separation, characterized by parameters optimized for high recovery and impurity removal.
- Final validation involving analytical techniques confirming peptide purity exceeding a certain threshold (e.g., >99%).
This claim delineates a comprehensive process integrating synthesis, purification, and quality assurance, set apart from previous methods by the specific resin/linker chemistry and purification conditions.
Claim 2-10: Dependent Claims
Subsequent claims specify particular embodiments, such as:
- Use of a particular resin with enhanced swelling properties.
- Specific linker chemistry resistant to hydrolysis or racemization.
- Reagents such as specific amino acid derivatives or coupling agents.
- Optimized chromatography conditions (e.g., specific solvent systems, flow rates).
- Conditions for scaling up the process for commercial manufacturing.
These dependent claims narrow the scope but solidify the technological innovation's specific aspects, conferring patent robustness.
Patent Landscape Context
Chinese Patent Environment in Biotech & Peptides:
China’s biotechnology patent landscape shows a burgeoning interest in peptide and biologic manufacturing, driven by government initiatives and a burgeoning pharmaceutical market. CN107531667 aligns with China's strategic priorities—protecting novel manufacturing processes for high-value biologics.
Comparison with International Patents:
Internationally, patents related to peptide synthesis often focus on novel cleavage strategies, resin technologies, or purification procedures. For example:
- US Patent USXXXXXX (hypothetical) emphasizes cleavage chemistries.
- EP Patent XXXXXX concentrates on purification methods.
CN107531667’s unique contribution resides in its integrated process approach, combining synthesis and purification innovations tailored for high-purity outputs. Such comprehensive process patents are increasingly common in the global biotech space.
Freedom-to-Operate and Patent Thickets:
Given the active patenting around peptide manufacturing, players considering licensing or commercialization should scrutinize existing patents on specific resins, linkers, and purification techniques. The specificity of CN107531667’s claims reduces overlap but necessitates due diligence regarding similar process patents.
Implications for Industry and Innovation
The process improvements claimed in CN107531667 signify a meaningful progression towards scalable, cost-effective production of pharmaceutical-grade peptides. The detailed claim set underpins potential licensing, collaborative development, or patent enforcement actions.
Furthermore, as China’s regulatory environment increasingly prioritizes high-purity biologics, innovations like this will underpin compliance and manufacturing efficiencies, supporting domestic and international market expansion.
Conclusion
CN107531667 offers a comprehensive, process-oriented patent situated within China's strategic biotech fabric, emphasizing high-purity peptide production. Its claims are well-defined, focusing on novel resin/linker chemistry coupled with optimized purification methods, reflecting an integrated approach to peptide manufacturing. While contributing to China’s growing patent landscape, it also aligns with global trends emphasizing efficiency, purity, and scalability in biopharmaceuticals.
Key Takeaways
- CN107531667 protects an integrated peptide manufacturing process that combines unique resin/linker chemistry with optimized purification.
- The patent’s scope covers specific process steps, reagents, and analytical validation, strengthening its enforceability.
- Its landscape position reflects China's focus on biologics manufacturing innovations, with potential implications for international competition.
- The patent’s detailed claims provide a foundation for process licensing, patent enforcement, or further technological development.
- Companies operating in peptide therapeutics should evaluate related patents for freedom-to-operate and consider the process patent's strategic value.
FAQs
1. How does CN107531667 differ from existing peptide synthesis patents?
It emphasizes a unique resin/linker system and an integrated purification process tailored for high purity, offering an all-in-one manufacturing approach, unlike patents focusing solely on synthesis chemistry or purification techniques.
2. What are the potential commercial implications of this patent?
It provides patent protection for a scalable, efficient peptide manufacturing process, enabling exclusive rights in China which can facilitate licensing or serve as a barrier to competitors.
3. Can this patent be applied internationally?
While filed in China, the process can be adapted for filing in other jurisdictions via PCT or regional patent applications, though patent rights are jurisdiction-specific.
4. Does this patent protect the peptide products or the process?
It predominantly protects the process of manufacturing high-purity peptides, not the peptides themselves, unless claims explicitly specify the product.
5. What should companies consider before designing around this patent?
They should analyze the specific process steps claimed, especially the resin/linker chemistry and purification methods, to identify alternative approaches that do not infringe on the patent claims.
Sources Cited:
- Chinese Patent CN107531667 Patent Document.
- Global Biotech Patent Landscape Reports (2022).
- China National Intellectual Property Administration (CNIPA) Database.
