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LRA® and its applications

LRA media was originally developed and intended to be used as a lipid sorbent in the production of biopharmaceuticals. Lipids although naturally occurring, can interfere in down stream processing of biopharmaceuticals e.g. chromatography column fouling, assay interference etc. LRA media provides outstanding performance in terms of lipid capacity, filterability, product recovery, and scalability.

More recently LRA has found multiple applications for Plasmid purification [1, 3, 5 see LRA® reference list], and endotoxin reduction in multiple laboratory and process scale applications. LRA media is also used in sample preparation and solid phase extraction. Being highly hydrophobic, LRA provides a very strong specific binding capacity to lipid moieties and polysaccharide endotoxins.

Today multiple processes have incorporated LRA in the process scheme to increase yields and recovery of valuable therapeutic biomolecules.

What is LRA®?

LRA media is a synthetic calcium silicate hydrate composed of 32% calcium oxide, 48% silicon dioxide, and residual levels of sodium, magnesium, and iron. It is produced at an FDA approved facility for GMP process use and is supplied with full analytical lot specific COA.

Lipid Specificity

LRA media demonstrates a high specificity for lipids and lipoproteins allowing for removal of contaminating lipids from biological streams without an adverse effect on non-lipids. To demonstrate this, we measured the potential for adsorption of various plasma proteins to LRA media. Following the incubation with cryo-reduced source plasma (samples were mixed for three hours at room temperature) soluble protein was measured by nephelometry. The results show that LRA media is specific for lipids and lipid associated proteins within the normal range of additions. Very little non-specific binding of non-lipid associated proteins was observed.

Table 1: Human Plasma Protein Profile Following Three Hour Room Temperature Incubation With LRA Media

Pressure Flow Curves

LRA media generates low differential pressures at moderately high flux rates (Figure 1). A bed height of 1cm generates differential pressures of 25 psi at a flux rate of 2400 LMH (240 cm/hr linear velocity). When the bed height is increased to 4 cm, the maximum flux rate is 600LMH (60 cm/hr linear velocity) for the same differential pressure. This linear relationship between pressure and bed height must be considered when designing a process using LRA media.

Figure 1: LRA: Differential Pressure Vs Flux

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