CRDMO Service
Full chain service capability for research, development, and production
As a CRDMO platform with over 20 years of dedication to peptide drug R&D, we have continuously developed technologies focused on cost reduction, efficiency improvement, product quality enhancement, and new peptide drug development. At the same time, we have established a formulation technology platform that supports multiple dosage forms. Therefore, the CRDMO platform enables stable, scalable, and efficient peptide development from early research to commercialization.
Molecular Design
Within the CRDMO molecular design framework, Bestbellpharma collaborates closely with strategic partners to strengthen engagement in AI-driven pharmaceutical research. Moreover, peptide chip detection is applied to analyze peptide–target interactions, while a proprietary database is built to support large-scale machine learning training.
Furthermore, reinforcement learning is introduced to optimize peptide generation processes. As a result, peptide molecules with high target protein binding specificity can be designed more efficiently. Consequently, the CRDMO platform accelerates early discovery and improves candidate selection quality.
Peptide & API Platform Capabilities
As part of the CRDMO API platform, one-stop services are provided from API development to commercial production. In addition, process development spans from mg-scale research to 10T-scale manufacturing in GMP workshops. Therefore, projects can smoothly transition across different development stages.
Meanwhile, the average delivery time is approximately 1.5 months, with the fastest turnaround of 25 days. As a result, project timelines remain predictable and controllable.
Moreover, the CRDMO peptide platform supports the development and production of nearly all marketed peptide APIs. In particular, it enables long-chain peptide APIs exceeding 30 amino acids and special complex peptides. Furthermore, advanced peptide synthesis technologies are applied, including peptide aldehydes, modified peptides, difficult-sequence peptides, cyclic peptides, and peptide nucleic acids.
Consequently, high-difficulty peptide APIs such as liraglutide and glatiramer have been successfully industrialized and recognized by international partners. Based on this experience, the CRDMO team delivers customized and diversified commercial peptide API production solutions for customers.
Quality Studies
Within the CRDMO quality studies system, a comprehensive quality research platform is established to meet regulatory application standards. In addition, an experienced team specializes in peptide and small-molecule mass research, supported by a robust quality management framework.
Drug impurity research applies 2D-HPLC combined with HRMS to identify both process-related and degradation impurities in peptides and oligonucleotides. Accordingly, tailored impurity control strategies are developed to ensure consistent quality.
Moreover, advanced drug structural research uses orthogonal analytical methods, including CD, SEC-MALS, and AUC. These techniques characterize secondary and tertiary structures as well as aggregation behavior, thereby meeting FDA and NMPA review requirements.
In vitro drug activity research further employs ELISA and cell-based assays to support pharmacological validation. As a result, structural optimization, candidate screening, and quality–activity relationship analysis are effectively supported within the CRDMO framework.
Technology Platform
Matrix assisted laser desorption time-of-flight mass spectrometer
Linear ion trap mass spectrometer
Combination quadrupole Orbitrap mass spectrometer
Single quadrupole inductively coupled plasma mass spectrometer
240 quadrupole ultra-high field Orbitrap mass spectrometer
Triple quadrupole liquid chromatography-mass system
Production System
Within the CRDMO production system, raw material production bases include multiple solid-phase and liquid-phase workshops equipped with world-class equipment. As a result, diverse process routes are available for both cost and quality optimization.
Meanwhile, multi-line production setups support different manufacturing scales and prevent capacity bottlenecks. Therefore, independent step-by-step processes reduce operational interference, minimize errors, and lower cross-contamination risks.
Formulation Production Capabilities & Facilities
Global Regulatory Affairs & Registration Support
Our global regulatory affairs team offers end-to-end registration support (IND/CTA, NDA/ANDA/MAA), tailoring submission materials and strategies. We engage with FDA/CDE and global authorities via multi-channel communication to facilitate market entry.Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Quality Studies
Equipped with a comprehensive quality research platform meeting application standards, an experienced team specializing in peptide and small molecule mass research, and a robust quality research system, including:
Drug impurity research: 2D-HPLC combined with HRMS identifies process/degradation impurity structures in peptides and oligonucleotides, with tailored control strategies.
Advanced drug structural research: Orthogonal methods (CD, SEC-MALS, AUC) characterize peptide/oligonucleotide secondary/tertiary structures and aggregation, meeting FDA/NMPA review requirements.
Packaging compatibility research: Customized plans for diverse dosage forms and packaging (borosilicate glass, rubber stoppers, plastic containers, etc.), with full reports complying with pharmacopoeias/regulations.
Technology Platform
High Efficiency Separation & Purification Platform: Equipped with UPLC/HPLC, 2D-UPLC, Fraction Collector for separating/purifying peptide/oligonucleotide intermediates and finished products.
High Sensitivity Quantitative Analysis Platform: Includes LC-TSQ, GC-MS, ICP-MS, CIEF, HPLC-CAD, ELISA Reader for quantitative analysis of peptide/oligonucleotide intermediates and finished products.Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Peptide Formulation Capabilities & Advantages
Process Development
References：Trends in Pharmacological Sciences, 2022, 43, 455-456.
Quality Studies
The quality research team has accumulated rich experience in the development of oligonucleotide drugs and has a profound understanding of the quality research projects for oligonucleotide drug development by EU and US regulatory agencies.
Production System
Capable of laboratory synthesis and collaborating with the oligonucleotide production workshop of the raw material drug production base to achieve the transition from preclinical research samples to commercial production. In response to the water oxygen sensitivity of oligonucleotide drugs, advanced oligonucleotide synthesis equipment is introduced to achieve full process automatic synthesis.
Process Development
