——Next-Generation Peptide CRDMO Solutions Based on a Green and Intelligent Platform Empower Global Innovative Drug Development
As the company’s portfolio of early-stage peptide and conjugate development projects continues to grow, the demand for downstream process scale-up and manufacturing becomes increasingly prominent. The completion of the peptide GMP pilot plant will strongly support the critical transition of client projects from early-stage R&D and kilogram-scale GMP to pilot-scale GMP production.
End-to-End GMP Facilities with Integrated Capacity from Synthesis, Cleavage to Purification and Lyophilization
1. Core Synthesis Platform
The plant is equipped with a core cluster of solid-phase peptide synthesis (SPPS) reactors with a total volume of 600L, including various specifications of 100L, 200L, and 300L, enabling flexible adaptation to needs ranging from process development to production exceeding 10 kilograms. The platform integrates automated fluid handling systems and high-purity inert gas protection technology to ensure process efficiency, stability, and batch-to-batch consistency.
2. Full-Chain Process and Downstream Processing Capabilities
- Cleavage and Purification: Equipped with two integrated cleavage systems made of corrosion-resistant materials, enabling fully enclosed processing from cleavage, concentration to precipitation, maximizing product purity and operational safety.
- Separation and Drying: Equipped with high-speed centrifuges and 12-tray large-scale tray dryers to meet large-scale downstream processing needs.
3. Graded Cleanroom Areas
The plant is managed with partitioned cleanroom standards of Grade D and Grade C. The Grade D area supports flexible front-end production, while the Grade C area meets high-standard production control requirements for critical downstream processes such as peptide API refining, lyophilization, and packaging.
4. Leading Preparative Chromatography System
High-resolution preparative purification platform: Equipped with a high-performance preparative chromatography system, featuring GMP-grade flow path design and excellent corrosion resistance, specifically engineered for purification in multi-system and complex operating conditions.
5. Intelligent Lyophilization Platform
Utilizes fully automated freeze-dryers with integrated multifunctionality. Through precise control of lyophilization process parameters, it efficiently ensures the reliability and stability of the lyophilization process, achieving consistent product delivery.
Dr. Minmin Yang, Chairman of PharmBlock, stated: “The commissioning of the first peptide GMP pilot plant marks a significant milestone in PharmBlock’s strategic layout in the field of novel molecular entities. Since its founding in 2008, PharmBlock has leveraged its core advantage in molecular building block design to gradually build a full-process CRDMO service system. After its successful IPO in 2017, the company accelerated platform upgrades and has now expanded its service capabilities to novel molecular entities such as oligonucleotides, peptides, and complex conjugates, establishing the OPC (Oligonucleotides, Peptides, Conjugates) division. In the peptide direction, leveraging deep understanding and synthesis experience in molecular building blocks, we can approach the field of peptides and their conjugates from a unique chemical perspective—relying on a vast library of non-natural amino acid building blocks, combined with innovations in green and intelligent peptide synthesis technology, PharmBlock has built core differentiated advantages in the peptide CRDMO field.”
PharmBlock is building a “Next-Generation Peptide CRDMO Platform” with green chemistry and intelligent manufacturing as its core philosophy. Different from traditional SPPS technical routes, this platform innovatively integrates multiple advanced technical approaches such as liquid-phase peptide synthesis (LPPS), continuous-flow liquid-phase peptide synthesis (CF-LPPS), and enzyme-assisted peptide synthesis (EAPS), enabling flexible customization of optimal processes for clients based on the specific structure of peptide molecules.