Repligen manufactures two membrane chemistries for use in flat sheet cassettes, ProStream and HyStream, in both ultrafiltration and microfiltration pore sizes. Both are modified Polyethersulfone (mPES) membranes validated for use in cGMP processes. The modification, achieved by the addition of a second polymer into the pre-casting membrane solution, ensures total and consistent surface modification.
Balanced flux and selectivity are achieved using a controlled manufacturing process that enables tight control of the membrane pore size. The manufacturing process ensures a controlled transition from the selective surface to the microporous support.
No breakthrough of the ultrafiltration skin, which maximizes selectivity performance
Enhanced microporous substructure pore size and even transition
Reduced number of manufacturing steps, which reduces cost and promotes excellent consistency and reliability
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
ProStream is neutrally charged, which minimizes non-specific protein binding. Unmodified PES has an inherent negative charge and will have non-specific binding.
ProStream membrane is neutrally charged, rendering it low binding for enhanced flux and recovery. The membrane has excellent chemical resistance and very low extractables, with performance comparable to Millipore Biomax, Pall Omega.
Molecular Weight Cut-off | SIUS® Single -use |
PRO Reusable |
---|---|---|
Ultrafiltration 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, 100kD, 300kD |
x | x |
HyStream membrane is extremely hydrophilic in nature, resisting fouling from hydrophobic specied such as fat, lipids, and various antifoam agents. The membrane has good chemical resistance and offers an alternative to RC membranes in some cases, with performance comparable to Millipore Ultracel, and Sartorius Hydrosart.
Molecular Weight Cut-off | SIUS® Single -use |
PRO Reusable |
---|---|---|
Ultrafiltration 5kD, 10kD, 30kD, 50kD, 100kD, 300kD |
x | x |
Microfiltration 0.1µm, 0.2µm, 0.45µm, and 0.65µm |
x | x |
Because HyStream membrane is modified to be very hydrophilic, the contact agent is lower than neutrally charged membranes.
Porous substructure of the TangenX® ProStream 10K membrane
The selective portion of an ultrafiltration membrane is the shiny surface layer known as the “skin” of the membrane. The layer beneath the skin is made up of a “finger pore” structure that supports the skin and facilitates liquid flow.
The scanning electron micrograph image shows uniformity in the finger pores of the TangenX® membrane substructure. This allows for minimal particle entrapment, which results in low fouling and maximum fluid flow. Repligen has developed this membrane substructure to ensure a defect-free surface and to provide maximum adhesion to the substrate while achieving highest possible flow rates.
Ultrafiltration membranes utilize nominal Molecular Weight Cut-offs as a measure of the pore size distribution across the membrane surface. The more uniform the pore size, the better the membrane’s selectivity is. A narrow pore size distribution means the membrane has high selectivity; i.e., the membrane has a high ability to differentiate between macromolecules of a more similar size.
The curves shown graphically represent the selectivity profile of several different membrane Molecular Weight Cut-offs offered by Repligen. Each membrane selectivity curve is distinctly separated from one another with no overlap and shows a high degree of selectivity. This leads to higher process performance and product yield.
The graph shows an optimization of transmembrane pressure (TMP) with a 30mg/ml monoclonal antibody feed stream. Under standardized conditions, Repligen's flux rate is highest at any given TMP. This results in greater process efficiency, a reduction in process time, and cost savings.
Source: IBC Applications for Biopharmaceuticals, La Jolla, CA, June 1-3 2009.
There are other factors can influence the selectivity and retentivity of a membrane. The shape of a molecule, presence of other solutes, pressure, adsorption and ionic conditions may affect membrane performance. A Repligen Field Application Specialist can help guide membrane selection for specific applications.
The following table shows typical use of flat sheet membrane chemistries by application.
Applications | Processes | Features | Advantages | |
---|---|---|---|---|
Ultrafiltration | Processing of protein solutions containing biomolecules (albumin, mAbs, lgG, lgM, hormones, growth factors, etc.) |
Concentration |
High flux High selectivity Void free Low protein binding High chemical resistance |
Less membrane surface Smaller system High yield Easy, rapid clean-up Excellent regeneration |
Microfiltration | Processing of cell culture(s) Fermentation broth |
Harvest |
High flux High selectivity Void free Low protein binding High chemical resistance |
Less membrane Smaller system High yield Easy, rapid clean-up Excellent regeneration |
Below, is the list of membrane disc sizes available. Please specify membrane type and molecular weight cut-off when ordering.
Membrane Size |
Quantity |
Part Number |
25 mm round | 12 pack | D025 |
44 mm round | 12 pack | D044 |
47 mm round | 12 pack | D047 |
63 mm round | 12 pack | D063 |
76 mm round | 12 pack | D076 |
90 mm round | 12 pack | D090 |
203 mm x 228 mm rectangle | 1 pack | SR01 |
203 mm x 228 mm rectangle | 5 pack | SR05 |
The X-Flo76 Membrane Screening System utilizes 76 mm membrane discs to determine the most advantageous balance of selectivity and flux.