Dilun-PC Production-Scale Peptide Cleavage System
| Brand | PSI |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | Dilun-PC |
| Pricing | Available Upon Request |
Overview
The Dilun-PC Production-Scale Peptide Cleavage System is an engineered solution for controlled, scalable deprotection and cleavage of resin-bound peptides following solid-phase peptide synthesis (SPPS). Designed in alignment with PSI’s legacy in mechanical agitation-based peptide instrumentation, the system implements 180° reciprocating mechanical stirring—a principle validated for uniform reagent penetration, minimized resin attrition, and enhanced mass transfer during acidic cleavage (e.g., TFA-based cocktails). Unlike static or overhead-stirred reactors, this agitation geometry ensures consistent exposure of all resin beads to cleavage reagents across multi-kilogram batch volumes, supporting GMP-aligned process reproducibility from late-stage development through commercial manufacturing. The system operates within Class C/D cleanroom-compatible enclosures and integrates with standard nitrogen purging, temperature-controlled jacketed vessels, and corrosion-resistant wetted materials (Hastelloy C-276, PTFE-lined components) to maintain integrity during aggressive cleavage chemistries.
Key Features
- 180° reciprocating mechanical agitation architecture—originally pioneered by PSI—to ensure homogeneous resin suspension and eliminate channeling in large-volume cleavage vessels
- Dual-reactor configuration: primary cleavage vessel (up to 5 L working volume) and auxiliary quenching/neutralization vessel, operable in parallel or sequential mode
- Programmable process control: fully configurable cleavage protocols—including stepwise reagent addition, dwell time, temperature ramping (0–40 °C), and agitation speed (10–60 rpm)
- Modular operation modes: fully automated batch execution, semi-automatic operator-guided steps, local HMI control, and secure remote monitoring via Ethernet/IP or OPC UA
- Full data traceability: real-time logging of all critical process parameters (temperature, pressure, agitation status, valve positions, timer events) with automatic backup to user-specified SQL or CSV-compatible databases
- Material compatibility: fluid-contact surfaces conform to USP Class VI and ASTM F2023 standards; designed for compatibility with TFA, DCM, phenol, water, and scavenger solutions
Sample Compatibility & Compliance
The Dilun-PC accommodates a broad range of resin types—including Wang, Rink amide, 2-chlorotrityl, and Sieber resins—and supports cleavage of linear and cyclic peptides up to 120 residues. It is validated for use with standard TFA-based cocktails (e.g., TFA/H2O/TIS, TFA/EDT/PhOH/H2O) and alternative low-TFA formulations. System design complies with ISO 13485:2016 (medical device QMS) and incorporates engineering controls aligned with ICH Q5C (stability of biotechnological products) and FDA 21 CFR Part 11 requirements for electronic records and signatures. All software-defined workflows support audit trail generation, user role-based access control, and change management logs suitable for GLP/GMP audits.
Software & Data Management
The embedded control software provides intuitive protocol authoring with drag-and-drop sequence building, parameter validation checks, and interlock logic (e.g., temperature must stabilize before agitation initiates). Data export adheres to ASTM E2500-15 (standard guide for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems) and supports CSV, PDF, and XML formats. Integration with LIMS and MES platforms is enabled via RESTful API or Modbus TCP. All electronic records include timestamped metadata, digital signature fields, and immutable audit trails compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Large-scale cleavage of therapeutic peptides (e.g., GLP-1 analogs, antimicrobial peptides, peptide hormones) under cGMP conditions
- Process development and tech transfer from lab-scale synthesizers (e.g., ACT Tetras, CEM Liberty Blue) to production-scale cleavage
- Support for CRDMO service providers requiring flexible, auditable cleavage capacity for diverse client peptide portfolios
- Parallel cleavage of multiple batches under identical conditions for comparative stability or purity assessment
- Integration into end-to-end SPPS platforms where cleavage is the final unit operation prior to precipitation, filtration, and lyophilization
FAQ
What resin loading capacities does the Dilun-PC support?
Standard configurations accommodate 100–500 g of dry resin per batch, scalable to 1 kg with optional reactor upgrades.
Is the system compatible with hazardous gas handling (e.g., HBr, HF)?
No—this system is engineered exclusively for liquid-phase cleavage chemistries. Handling of gaseous reagents requires dedicated fume hood-integrated infrastructure not included.
Can cleavage protocols be exported and shared across instruments?
Yes—protocols are stored as encrypted .xml files and can be imported/exported between Dilun-PC units with version-controlled revision history.
Does the system meet FDA 21 CFR Part 11 requirements out-of-the-box?
Yes—full electronic signature capability, audit trail, and role-based permissions are preconfigured and factory-validated.
What maintenance intervals are recommended for the agitation mechanism?
Lubrication and torque verification every 500 operational hours; full gearbox inspection annually or after 2,000 cycles—documentation provided in the IQ/OQ/PQ validation package.
