MilliporeProstak Frame-Based Production-Scale Ultrafiltration System
| Brand | Millipore |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Import Status | Imported |
| Model | Prostak |
| Pricing | Available Upon Request |
Overview
The MilliporeProstak Frame-Based Production-Scale Ultrafiltration System is an engineered, scalable tangential flow filtration (TFF) platform designed for robust, repeatable processing of biopharmaceutical intermediates and final products in clinical and commercial manufacturing environments. Built upon a modular frame architecture, the system leverages proprietary heat-fused membrane stack construction—eliminating adhesives and maximizing chemical and thermal resilience. It operates on the principle of crossflow ultrafiltration (UF) and microfiltration (MF), enabling high-recovery concentration, diafiltration, clarification, and buffer exchange of sensitive biomolecules—including monoclonal antibodies, viral vectors, plasmid DNA, recombinant proteins, and cell-based therapeutics—while maintaining structural integrity and process consistency across batch-to-batch operations.
Key Features
- Adhesive-free, thermally fused membrane stacks: Membranes are heat-bonded directly to polypropylene support layers using precision thermal lamination—ensuring zero extractables, no delamination risk, and full compatibility with aggressive cleaning-in-place (CIP) and steam-in-place (SIP) protocols.
- Multi-material membrane options: Select from three certified, GMP-compliant membrane chemistries—regenerated cellulose (RC) for organic solvent tolerance, polyethersulfone (PES) for broad pH stability (pH 1–14) and high flux performance, and polyvinylidene fluoride (PVDF) for high-temperature sterilization (126°C, 60 min, ≥20 cycles).
- Scalable membrane area configurations: Available in standardized stack formats—4-layer, 10-layer, and 20-layer assemblies—with nominal effective filtration areas of 0.39 m², 0.93 m², and 1.9 m² respectively—enabling seamless tech transfer from process development to commercial-scale production.
- Dual-stack architecture: Distinct Prostak UF stacks (with tight molecular weight cutoffs for protein concentration and endotoxin removal) and Prostak MF “open-channel” stacks (optimized for high-solids clarification of mammalian cells, bacterial cultures, mycelial suspensions, emulsions, colloids, and precipitated proteins).
- Chemical resistance validated per USP and : RC membranes withstand ethanol, acetonitrile, tetrahydrofuran, ethyl acetate, and acetone—supporting solvent-based diafiltration, polysaccharide purification, and peptide recovery workflows.
Sample Compatibility & Compliance
The Prostak system is validated for use with high-viscosity, high-particulate, and shear-sensitive feed streams—including CHO and HEK293 cell harvests, E. coli lysates, fungal fermentations, antibody–drug conjugate (ADC) intermediates, and vaccine candidates. All membrane materials comply with ISO 10993-5 (cytotoxicity), USP Class VI, and FDA 21 CFR Part 11–ready data integrity requirements when integrated with compatible supervisory control software. The system supports GLP/GMP documentation packages, including IQ/OQ/PQ protocols, material traceability records, and sterilization cycle logs compliant with ASME BPE-2023 and Annex 1 (EU GMP) standards.
Software & Data Management
When paired with MilliporeSigma’s ProcessView™ or third-party SCADA systems (e.g., Siemens Desigo CC, Rockwell FactoryTalk), the Prostak platform enables real-time monitoring of transmembrane pressure (TMP), retentate and permeate flow rates, temperature, and conductivity. Audit trails, electronic signatures, and configurable alarm thresholds meet FDA 21 CFR Part 11 and EU Annex 11 requirements. Batch records are auto-generated with time-stamped metadata—including membrane lot numbers, SIP cycle parameters, and CIP chemical concentration logs—for full regulatory traceability.
Applications
- Clarification of high-density microbial and mammalian cell cultures prior to chromatography
- Concentration and buffer exchange of monoclonal antibodies, bispecifics, and Fc-fusion proteins
- Endotoxin reduction in small-molecule APIs and oligonucleotide formulations
- Recovery and polishing of viral vectors (AAV, lentivirus) and plasmid DNA
- Organic solvent-mediated purification of peptides, glycoproteins, and natural product extracts
- Processing of thermally stable vaccines and adjuvanted formulations requiring repeated SIP cycles
FAQ
What sterilization methods are validated for Prostak membrane stacks?
Prostak PVDF MF stacks are validated for steam sterilization at 126°C for 60 minutes, with ≥20 cycles; RC and PES stacks support autoclaving (121°C, 30 min) and gamma irradiation (25–40 kGy).
Can Prostak UF stacks be used for endotoxin removal?
Yes—when operated under controlled TMP and optimized diafiltration conditions, Prostak RC and PES UF membranes achieve >3-log reduction of endotoxin per USP , particularly for low-endotoxin-specification products.
Is the system compatible with single-use bioprocessing infrastructure?
The Prostak frame is reusable and designed for integration into hybrid stainless-steel/skidded or fully single-use processing trains via standardized tri-clamp and sanitary flange interfaces (DIN 11851, SMS 1143).
How is membrane fouling mitigated during long-duration runs?
The open-channel MF design and uniform flow distribution across the heat-fused stack geometry minimize concentration polarization and particle bridging—validated by >90% flux recovery after standard CIP sequences using NaOH (0.5 M) and citric acid (1%).
