SEPABEADS FUNCTIONALISED POLYMERS FOR CHROMATOGRAPHY

The major cost of production of therapeutic biomolecules is on account of the multi-step sequence of purification processes. Often the sequence of downstream processing (DSP) operations begins with primary steps whereby the target compound is concentrated, along with the associated impurities. Isolation and purification from the concentrated ‘extract’ means lower capital cost in equipment for further processing, while at the same time making it easier to exploit the differences in the physico-chemical properties between the product and the impurities.

Invariably, chromatographic steps are the method of choice. Secondary purification methods are more specific and hence more elaborate. Invariably, chromatographic steps are the method of choice. Typically a DSP sequence of operation can have more than one chromatographic steps interspersed with techniques like diafiltration, ultrafiltration or precipitation and centrifugation.

Chromatography: Media, hardware and methods. The usefulness and the need for chromatographic separations can be assessed from the proven power of HPLC. Developments over the last three to four decades have proved that it is possible to separate almost anything on analytical HPLC with the right column and suitable operating procedures. Tailored design of adsorbents has further led to extremely high specificity in chromatographic separations. However, transforming the power of analytical HPLC to preparative scale separations of biomolecules, especially the macromolecular proteins, requires special considerations.

These considerations are related to: Design of the suitable adsorbent matrix Design of mode of product-matrix interactions Design of bench scale to plant scale equipment and operating protocols After choosing an adsorbent with desirable surface with binding sites, the next step involves scouting for the right combination of operational parameters like binding, washing, elution and regeneration conditions and operating flow velocities.

SEPABEADS FP AND EB PRODUCTS LINE (I) SEPABEADS FP/EB-CM Carboxylic SEPABEADS FP/EB-SP Sulphopropil SEPABEADS FP/EB-QA Quaternary Ammonium SEPABEADS FP/EB-DA Diethylamino

SEPABEADS FP AND EB PRODUCTS LINE (II) SEPABEADS FP/EB-BU Butyl SEPABEADS FP/EB-OD Octadecyl

SEPABEADS FP AND EB PRODUCTS LINE (III) SEPABEADS FP/EB-IDA Iminodiacetic SEPABEADS FP/EB-EP Epoxy

SEPABEADS FP AND EB PRODUCTS LINE (IV) Particle size: FP line: 90 – 250 µm EB line: 150 – 300 µm Pore diameter: 80 – 150 nm Also available with pore diameter > 500 nm

SPECIAL FEATURES OF SEPABEADS FP AND EB (I) SEPABEADS FP AND EB are polymeric chromatographic beads, with various functional groups and calibrated porosity. Example of high porosity grade polymer structure SEM picture of a SEPABEADS polymer

SPECIAL FEATURES OF SEPABEADS FP AND EB (II) A rigid highly porous and hydrophilic acrylic matrix characterize the SEPABEADS line allowing to overcome many of the difficulties generally associated with use of soft gel media (i.e. dextrane, agarose, cellulose derivatives). Stability, easy handling and economic advantages make SEPABEADS suitable for industrial use at various scale processing in fixed bed (FP series) and expanded bed (EB series) application mode. The high specific gravity (> 1.1) allows controlled bed expansion and easy settlement

SPECIAL FEATURES OF SEPABEADS FP AND EB (III)

SEPABEADS LINES HIGH QUALITY Chemically stable and not degradable by micro-organisms polymer structure High functional group stability in acids, alkalis and solvents Lower beads compressibility that provides high flow rates and high column bed size High mechanosmotic resistance associated to negligible beads volume change under pH, salt concentration and solvents variation Available with different porosity degrees and customized particle size ranges

BED VOLUME STABILITY (I) SEPABEADS® resins maintain stable bed volumes during the changes in pH, ionic strength and solvents. Repeated gradient separations and re- equilibrations can be performed without repacking a column. The volume changes have been measured against the variation of different parameters (pH, ionic strength)

BED VOLUME STABILITY (II)

MULTI-CYCLES OPERATIONAL STABILITY

FROM HPLC TO INDUSTRIAL APPLICATION

SEPABEADS FP AND EB PRODUCTS REGULATORY SUPPORT FILE RDN commitment to the quality of SEPABEADS FP and EB products is ruled by ISO9001:2000 as part of RDN corporate strategy for the highest customer satisfaction degree. The monomers applied to manufacture SEPABEADS FP and EB comply with the European Resolution AP(97)1, which rules the application in the Food processes. As typical Regulatory support file, the following documentation is released: product description material safety data sheet storage conditions and limitations (if any) standard specification detailed quality control procedures lot-to-lot certificate of analysis Special Regulatory support studies are offered under request