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Recombinant Protein Manufacturing

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Biopharmaceutical Manufacturing

When you work in the biotech industry, your aim is to reduce the time to market and improve the efficiency of the of biologics manufacturing process. 3M wants to help you do that.

3M products combine our expertise in material science, filtration and polishing of proteins to provide solutions in upstream and downstream processing of biologics. 3M™ Zeta Plus™ Depth Filters, 3M™ Emphaze™ AEX Hybrid Purifier, 3M™ LifeASSURE™ Filters and 3M™ Polisher ST are single-use products that enable platformability and robust purification across diverse biopharmaceutical modalities. They are designed for all process stages from lab scale to manufacturing.

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Monoclonal Antibodies Manufacturing

Monoclonal antibody (mAb) therapeutics manufacturing requires robust, scalable solutions throughout the process train from clarification to polishing.

3M Zeta Plus Depth Filters and 3M Emphaze AEX Hybrid Purifier are uniquely designed specifically for the biopharmaceutical industry, to optimise cell harvest and meet clarification needs. 3M Polisher ST is a new product engineered to be a single-use cost-efficient option, to increase yield and purity in therapeutic recombinant protein processes across most operating conditions.The newest 3M solution, 3M™ Harvest RC, utilises fibrous anion exchange (AEX) chromatography to efficiently separate cells, cell debris and DNA from the harvest fluid containing the target product.

3M Harvest RC

3M Harvest RC is a high product recovery (> 95%), single-stage, single-use, encapsulated harvest and clarification solution for recombinant proteins expressed in high-density Chinese Hamster Ovary (CHO) cell cultures. It contains an innovative fully synthetic fibrous anion exchange chromatography media, combined with 0.2 µm polyethersulfone (PES) membrane, to enable a high degree of soluble and insoluble contaminant reduction while protecting the final sterilising grade membrane down to 0.1 µm in pore size. 3M Harvest RC is a chromatographic single-stage clarification and versatile product line enables simple deployment and consistent scale-up of the system from discovery to manufacturing across different cell cultures.

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3M Emphaze AEX Hybrid Purifier

3M Emphaze AEX Hybrid Purifier is a single-use technology for polishing stage clarification of mammalian cell culture fluid and is designed to reduce both soluble (DNA and HCP) and insoluble impurities. 3M Emphaze AEX Hybrid Purifier combines two types of media: Q-functional nonwoven and a membrane that work together to provide high clarification efficiency in a single clarification stage. The 3M Zeta Plus Depth Filter and 3M Emphaze AEX Hybrid Purifier enable centrifuge replacement with a scalable single-use system.

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3M Polisher ST

3M Polisher ST is our latest solution: a cost-efficient, single-use option to maximise purity and yield in the polishing of recombinant proteins across a wide range of operating conditions. 3M Polisher ST can be used to replace the downstream AEX polishing column in both fed batch and continuous manufacturing. It is a compact, small footprint solution with high loading capacity. 3M Polisher ST allows for a facility strategy that can overcome scale limitations and enable cost-efficient manufacturing, to support the growing demand for biologics. To facilitate this, it can be deployed in a batch process or as part of a connected continuous downstream process for the flexible facility of the future.

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Bioprocessing reimagined

With the acceleration of marketplace demands, getting the most out of your manufacturing process with speed and on budget is an increasing challenge to address. 3M’s fiber chromatography technology enables high performance single-stage clarification and purification solutions to provide achievable process train intensification options. Our single-stage technologies offer predictable scalability from discovery to commercial production, compress multiple steps into one, and help simplify your operations. See how our chromatographic harvest and purification systems can help shorten traditional process trains to reduce total manufacturing cost and increase speed to market.

3M Solutions

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Next-generation process

Product Categories | Biomanufacturing Purification Platform

To help boost your biopharmaceutical manufacturing efficiency, 3M offers a robust portfolio of pharmaceutical manufacturing products – from membranes and hybrid chromatographic purifiers to depth filtration systems and process hardware. Our filtration and purification products are designed for robust performance, efficiency and easy scale-up from lab scale to production scale.

Harvest and Clarification

The goal of harvest and clarification is to prepare your cell culture process fluid for downstream purification. 3M Zeta Plus Depth Filters and 3M Emphaze AEX Hybrid Purifier help biopharmaceutical drug manufacturers design and deploy robust clarification processes. 3M solutions are designed for recombinant therapeutic proteins expressed in mammalian cells as well as plasma-derived proteins.

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Next-Generation Harvest

3M™ Harvest RC is the next generation in harvest and clarification technology for high cell density cultures. This solution is designed as an efficient option to increase monoclonal antibody (mAb) yields while simplifying the upstream process by replacing the centrifuge and/or depth filtration unit operations.

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Hybrid Chromatographic Purifiers

We combine advanced anion exchange (AEX) chromatography media, fine fibre nonwovens and fine particle reduction membranes to create novel purification solutions. The result is a synthetic, single-use clarifying product that provides high purity.

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High-Purity Activated Carbon Filters

With five standard types of activated carbon filters for a broad range of uses, 3M offers you a high degree of application flexibility. Our filter portfolio is designed for purification of a range of chemical and biological pharmaceutical fluids.

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Harvest and polishing solutions

Harvest
Introducing 3M™ Harvest RC: a new single-stage, single-use chromatographic clarification solution. It is the next generation in harvest and clarification technology and is designed as an efficient option to increase monoclonal antibody (mAb) yields while streamlining the upstream process by replacing the centrifuge and/or depth filtration process steps.

Capsule format enables typical product recoveries of >95%

Replaces primary, secondary, and guard membrane clarification stages

Predictably scales from discovery to manufacturing in terms of clarification consistency and cell loading capacity

Fits into discovery to manufacturing scale workflows with a range of product formats

Lowers total cost of manufacturing compared to conventional approaches
Polishing
The goal of the polishing step is fast and efficient removal of residual contaminants in your process to achieve injectable product purity in the least number of polishing steps. 3M™ Polisher ST is a fully encapsulated single-use anion exchange (AEX) product intended to reduce host cell protein impurities, viruses and other negatively charged contaminants in flow-through polishing chromatography of biopharmaceutical process streams.

3M Polisher ST combines two complementary synthetic AEX functional medias: a quaternary ammonium (“Q”) functional nonwoven and a guanidinium-functional membrane. The Q-functional nonwoven provides reduction of turbidity (when present), DNA and endotoxin, as well as a portion of the product’s AEX capacity for HCP and virus reduction. The guanidinium functional membrane is salt tolerant and provides high HCP and virus reduction performance in a wider range of conditions compared to conventional Q-functional AEX resins.

3M Polisher ST eliminates the need for packing and cleaning validation and has 100X higher binding capacity to proteins, viruses, virus-like particles and other large complexes when compared to resins.

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Looking to simplify your process?

The innovation and development in cell culture production has created additional complexities for the clarification process. 3M offers single-stage and single-use solutions to help simplify your process and increase manufacturing efficiency.

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Featured Applications

From cell culture fluid clarification and soluble impurity reduction to mycoplasma retention and final sterilizing filtration, our technologies deliver economical, robust solutions for a wide variety of applications within biopharmaceutical production.

Cell Culture Clarification

Clarification tools designed for particle size control in clarified cell culture fluid. 3M offers efficient depth filters that enable high throughput. This can eliminate the need for centrifugation and enables implementation of a fully single-use clarification process train, completely scalable from lab to pilot to manufacturing scale.
Chromatography Column Protection

Reduce insoluble impurities to help prevent plugging or fouling of capture and polishing chromatography columns.
Bioburden Control

Reduce microorganisms and control fine particles downstream.
DNA Removal

Reduce DNA to target specification to help meet U.S. FDA requirements for protein therapeutic formulations.