bridging upstream and downstream bioprocessing
Backed by independent, peer-reviewed studies and proven in real-world applications, Sani Membranes’ Vibro® Membrane Filtration (VMF) technology helps partners achieve higher yields, lower costs, and robust process performance—no matter where they are on their bioprocessing journey.
PROCESS OPTIMIZATION & SIMPLIFICATION
Biomanufacturing is a highly integrated, multi-stage process that transforms living cells into purified, high-value bioproducts. Its workflow is typically categorised into Upstream and Downstream processing, with the intermediate steps between the two increasingly being called Midstream. Each stage presents unique technical challenges and opportunities for innovation.
Vibro® Membrane Filtration (VMF) is designed to optimize, simplify and intensify all three stages, providing stable operation at uniform TMP as well as gentle, efficient filtration even of highly viscous or concentrated media. It also has the potential to replace or eliminate entire process steps, such as centrifugation.
Upstream Processing
Seed Train Expansion and Cultivation
Upstream processing involves growing the target organism from the cell bank through seed train steps to final production scale inside a bioreactor.
Technical Considerations
Industry Trends
How Can VMF Improve Upstream Processing?
VMF supports robust and scalable cell retention technology for seed train intensification and perfusion, handling high cell densities with minimal fouling and gentle processing.
Two-fold bleed stream productivity increase
Recovery of API from bleed stream.
- Continuous and sustainable yield optimization from perfusion process
- Fully comparable / compatible API quality
Seed train intensification
Cell retention device to improve upstream processing.
- Shorten seed trains
- Increased cell density
Perfusion stream processing
Cell retention device for perfusion processes.
- Improved product yield
- Sustainable long-term performance
MIDstream Processing
Primary Recovery and Clarification
Midstream processing, often referred to as primary recovery, bridges the gap between cell cultivation and product purification. It involves harvesting the cells grown during upstream processing from the culture broth, e.g. via centrifugation, their lysis to release the target proteins or nucleid acids within and finally the clarification of the lysate to remove cell debris, DNA and other impurities from it.
Technical Considerations
Industry Trends
How Can VMF Improve Midstream Processing?
VMF excels in clarification and primary recovery, enabling extracellular product recovery with minimal cell damage as well as high-yield separation of cell debris for intracellular products, all using the very same technical solution.
Harvest clarification
Recovery of API from microbial and mammalian cell suspensions.
- Unique process control, low TMP & high API transmission
- High cell concentration, low cell damage
- Reusable cartridge
Clarified harvest intensification
Single-pass concentration of clarified harvest.
- Downstream intensification for improved capture step capacity
- Robust, continuous in-line process step
Combined cell harvest and recovery of intra-cellular APIs
One process technology for the recovery of intracellular API from bioreactors
- Harvest of cells for subsequent lysis step
- API recovery by clarification of cell lysate
Perfusion stream processing
One process solution for combined harvest clarification and API concentration.
- Single operation to concentrated, clarified harvest
- Increased capture step capacity
- Inline clarified harvest concentration (MF in batch mode coupled with inline concentration)
- Tandem solution: MF and UF in batch mode, coupled
downstream Processing
Downstream processing transforms the clarified product stream into a highly purified, formulated, and stable final product that meets regulatory and quality standards. It involves the capture and purification of the target molecule via chromatography, its concentration via ultra-/diafiltration, the removal of any remaining viruses and impurities as well as final formulation and filling.
Technical Considerations
Industry Trends
How Can VMF Improve Downstream Processing?
VMF in batch operation or single-pass mode can be used as part of process intensification strategy for improved capacity of the first capture chromatography step, as well as for efficient ultrafiltration for concentration and buffer exchange.
Concentration and Buffer Exchange
Gentle, low shear UF processing
- Efficient concentration, buffer exchange and diafiltration
- Processing at higher viscosities
- Batch or inline, continuous mode
- Low product impact, low energy consumption
Nano Lipid Particles Processing
Concentration, purification and buffer exchange of NLP suspension.
- Gentle, low shear impact technology
- Retaining size distribution of the NLP suspension
Articles
Single-Pass VMF of Precipitated mAbs
Precipitation combined with Single-Pass Vibro® Membrane Filtration (VMF) is an interesting alternative to Protein A chromatography for the continuous purification of precipitated mAbs.
Single-Pass VMF of mRNA
Single-Pass VMF significantly enhances the performance of in-line concentration and purification of mRNA constructs, with more than triple the sustainable flux rates reported for conventional single-pass TFF.
VMF of E. coli Cultures & Lysates
VMF performs better than conventional TFF for the processing of high‑density E. coli cultures and lysates, making it a robust, high-performance solution for demanding midstream applications.
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