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Biopharmaceutical Manufacturing

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3M Biopharmaceutical Solutions

  • We work with our industry partners to develop better, more efficient manufacturing of safer products that transform lives. For over thirty years, our dedicated technical services and laboratory personnel has been solving the most complex biopharmaceutical manufacturing problems, while cutting-edge 3M technology addresses all your filtration needs.
    At 3M, we offer a portfolio of biopharmaceutical manufacturing products ranging from membranes, to chromatography filters, to depth filtration systems and process hardware that improve process efficiencies.


Traditional mAB Process


LifeASSURE™ PDA

LifeASSURE™ PDA is a low binding dual layer polyethersulfone membrane that allows for high throughputs and flowrates. It is available in 0.2μm and 0.1μm sterilising grade. The 0.1μm pore size is particularly useful for mycoplasma control.

Clarification

Where the product is extracellular the first major step in the purification process is to remove the cells, as these are unwanted, and keep the fluid that contains the product. This is usually achieved by depth filtration or centrifugation

Virus Filter

A virus filter removes viruses by size exclusion and has pore sizes typically in the range of 15nm-35nm. It is often employed as one of the two orthogonal virus removal/inactivation steps.

Polishing Chromatography

A mAb process will typically have two polishing steps. Their purpose is to reduce remaining Host Cell Protein, DNA, leached protein A and product related impurities like aggregates so that the required product purity is achieved

Protein A Chromatography

As the primary capture step, protein A’s specificity for antibodies enables a large amount of process related impurities in a mAb solution to be removed in a single step.

Emphaze™ AEX Hybrid Purifier

The Emphaze™ AEX Hybrid Purifier is a chromatographic clarification device complementary to the EZP system. This high capacity anion exchange nonwoven reduces Host Cell Protein and DNA early in the process which can improve protein A column performance.

Ultrafiltration(UF)/Diafiltration (DF)

UF is used for purification/concentration of the product and DF is used for buffer exchange. They are typically used when a change in concentration or buffer is required.

Low pH Viral Inactivation

At least two orthogonal viral removal/inactivation steps are required in a bioprocess. A low pH inactivation is typically employed in mAb processes as acidic conditions are used to elute from the protein A column.

Polishing Chromatography

A mAb process will typically have two polishing steps. Their purpose is to reduce remaining Host Cell Protein, DNA, leached protein A and product related impurities like aggregates so that the required product purity is achieved

Encapsulated Zeta Plus™

Encapsulated Zeta Plus™ (EZP) is an ergonomically designed single use system. The filter media is available in different retention ratings suitable for coarse to fine clarification and with different adsorptive properties for specific impurity removal.

LifeASSURE™ PDA

LifeASSURE™ PDA is a low binding dual layer polyethersulfone membrane that allows for high throughputs and flowrates. It is available in 0.2μm and 0.1μm sterilising grade. The 0.1μm pore size is particularly useful for mycoplasma control.

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Biopharmaceutical Manufacturing Products

  • 3M™ Emphaze™ AEX

    Our 3M Hybrid Technology combines advanced polymer materials, fine fiber nonwovens and membranes into a novel purification media. The result is a delivery of an all-synthetic clarifying product containing both a novel anion exchange nonwoven media, and a fine particle, bioburden reduction membrane.

  • 3M™ Zeta Plus™

    For optimal clarification of biopharmaceutical manufacturing fluids, 3M’s extensive line of depth filters is versatile and adaptable for many processes. Our pharmaceutical-grade filters have high contaminant-holding capacity and provide economical filtration with reliable particle reduction.

  • 3M™ LifeASSURE™

    3M’s range of LifeASSURE™ Membrane filters feature unique Advanced Pleat Technology that maximises the useful surface area of the filter while maintaining open flow paths between media pleats. Our membrane filters are optimised for applications requiring critical sterilisation where 0.2μm absolute-rated filtration is required.


Resources

  • 3M™ Zeta Plus™ Single Use Depth Filtration Portfolio
  • 3M™ Emphaze™ AEX
  • 3M™ Zeta Plus™ Encapsulated Systems
  • 3M™ LifeAssure™ PDA 010
  • 3M™ LifeAssure™ PDA Series

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