Protein Degrader Process Development and Manufacturing

In drug development, solubility, permeability, degradation selectivity, and stability are critical factors. However, the ease of synthesis and cost also significantly influence the industrialization process. Protein degraders (proteolysis-targeting chimeras) have emerged as a hot topic in drug research and development in recent years due to their unique mechanisms of action and potential applications. Unlike traditional small-molecule drugs, protein degraders possess distinct physicochemical properties, such as high molecular weight and complex structures, presenting unprecedented challenges for the synthesis and purification of their APIs. Leveraging its superior CDMO service capabilities, Creative Biogene offers comprehensive protein degrader solutions from R&D to commercial production.

Detailed Service

1. Custom Synthesis and Process Development

Creative Biogene's experienced chemical R&D team provides:

Custom synthesis of E3 ligase ligands and derivatives: Including the ligands of CRBN, VHL, cIAP, and MDM2, with scalable production from milligrams to grams.
Efficient linker optimization: Ensuring optimal balance among protein degrader activity, selectivity, stability, and physicochemical properties.
Small molecule-protein degrader conjugation process development: Precisely controlling critical parameters to achieve high yield and purity.

2. Impurity Identification and Control Strategies

Addressing the challenges of high impurity complexity in protein degrader API synthesis, we offer:

Analysis and elimination of unknown residual solvents: Utilizing advanced NMR and GC-MS technologies to identify impurity sources and optimize processes quickly.
Catalyst deactivation problem resolution: In-depth analysis of raw materials and intermediates to prevent catalyst deactivation and improve reaction efficiency.
Impurity profiling: Using technologies like LC-MS to determine impurity structures accurately, trace impurity formation pathways, and devise removal strategies.

3. Process Optimization and Scale-Up Production

Understanding the unique requirements of protein degrader industrial production, we provide:

Crystallization and purification technologies: Tailored to molecular characteristics, prioritizing crystallization over column chromatography to enhance product purity and yield.
Post-reaction process improvements: Introducing mildly alkaline solid powders (e.g., potassium carbonate or potassium phosphate) to effectively decompose high-molecular-weight impurities, improve intermediate physical properties, and facilitate main reactions.
Comprehensive process development: Optimizing feeding, temperature control, and post-processing to deliver cost-effective and efficient solutions.

4. Professional Consultation and Technical Support

Upholding the concept that innovation drives development, we offer:

Offering end-to-end protein degrader development support, from design and synthesis to industrialization.
Delivering innovative solutions for specific challenges, such as novel catalytic system development and non-traditional linker designs.

Advantages of Our Service

1. Top-Notch R&D Team: Our R&D team is led by Ph.D. experts in chemistry and molecular biology. Core members possess over ten years of experience in process development and quality research. Driven by a commitment to excellence and client satisfaction, the team ensures result-oriented, high-quality service delivery.

2. Comprehensive Quality and Compliance Systems: Creative Biogene has established stringent quality management and EHS systems to ensure scientific and compliant R&D processes and deliver authentic, complete, and traceable data.

3. Global Service and Client Support: We serve leading pharmaceutical companies and innovative biotech firms across the U.S., Europe, and China. Our technical and service capabilities comply with regulatory requirements in these regions, meeting the demands of global markets.

4. Advanced Technical Platforms and Core Capabilities: Creative Biogene excels in building advanced technical platforms, including poorly soluble drug solubilization (e.g., spray drying, hot melt extrusion), sustained and controlled release technologies, and innovative liposome delivery systems. Our cutting-edge technical expertise propels client projects toward commercialization, contributing to the successful launch of multiple innovative drugs.

Contact Us

Let us help you navigate the complex challenges of protein degrader synthesis and manufacturing, ensuring that your innovative solutions are brought to market efficiently and successfully.

* For research use only. Not intended for any clinical use.

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