The filtration of complex biotech drugs, such as highly concentrated mAb and gene therapy products, comes with unique challenges. These can include premature blocking due to high particulate loads, high differential pressures due to high viscosities, and risk of bacterial penetration. These conditions result in a need for larger filters or additional filters, leading to unnecessary product loss.

Supor™ Prime sterilizing grade filters have been developed to meet these challenges. The high throughput of Supor™ Prime filters allows for reduced filtration area. By reducing the necessary filtration area, a smaller filter can be used resulting in less drug product lost to pre-conditioning and hold-up. This membrane also shows excellent transmission properties, minimizing the loss of active ingredients and excipients such as polysorbate.

Supor Prime should be the first consideration for critical downstream applications in late-stage drug substance and drug product. The extensive validation package provides enhanced confidence that this filter will perform as expected. The high bubble point ensures validation success, even for high-risk fluids such as lipid nano particles. The membrane material is polyether sulfone (PES) which is PFAS free.

Typical applications include:

• Sterile filtration post ultrafiltration/diafiltration (UF/DF)
• Sterile filtration of bulk drug substance
• Sterile filtration prior to filling

In addition to cartridges for stainless steel housings, Supor™ Prime filters are offered in the new Kleenpak™ Spectrum capsule for single-use applications:

• High temperature and pressure rating to ensure robustness in challenging applications
• vent/drain valve easy to operate with gloved hands
• Vent/drain valve actuators decoupled from connector to reduce risk of tubing interference

Supor™ Prime filters are offered in a range of filter formats and sizes, designed to support all development stages from benchtop testing to clinical trials and full scale good manufacturing practices (GMP) manufacture:

• Small Kleenpak Spectrum capsules and 47 mm discs to support filterability studies.
• Medium Kleenpak Spectrum capsules suitable for single-use applications. With a filter area of 240 cm² this format is typically used for volumes of > 1 L.
• Large Kleenpak Spectrum capsules suitable for single-use applications, available in four different areas ranging from 0.1 to 4 m² this format is typically used for volumes from 10 to > 100 L.
• Traditional cartridges ranging from 0.6 to 4 m² to support stainless steel applications.

Contact a Cytiva associate today for more information on how we can test our Supor™ Prime filter on your high-concentration mAbs, protein, LNP, mRNA, or any other challenging feeds. Download our datasheet in the Related Documents section for more technical information.