Innovative Purification Technologies to Boost Growth in European Biomanufacturing Markets

Solutions help optimize unit processes and deliver filtration consistency to protect downstream unit operations while reducing operating costs, finds Frost & Sullivan

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Frost & Sullivan

Mar 04, 2020, 09:48 ET

SANTA CLARA, Calif., March 4, 2020 /PRNewswire/ -- The increased production of monoclonal antibody (mAb) is posing various challenges in both upstream and downstream processes in drug manufacturing, creating an urgent need for next-generation harvest and clarification technologies and techniques. These technologies will make the process scalable, reduce buffer consumption and make continuous manufacturing possible. However, implementing new processes and technologies requires extensive validation to ensure performance, time, quality, yield, and other metrics are not compromised. Furthermore, it requires intricate planning, often across multiple manufacturing sites, so there are no disruptions to the supply chain.

Frost & Sullivan's executive briefs offer insights into high-performance purification platforms and the innovation priorities of global biopharma R&D teams. Key Trends Reshaping the Future of Bio-pharmaceutical Harvest & Clarification (H&C) identifies the process design challenges, interdependencies and limitations of the current H&C technologies and presents insights into benefits of leveraging new high-performance purification platforms. Plus, A Frost & Sullivan Perspective on Next Generation Harvest Techniques reveals insights into challenges, strategies, techniques, and barriers to new purification technology implementation in mAb therapeutics production.

To download the complimentary executive briefs, please visit:
https://go.frost.com/harvest.

"To develop an efficient harvest and clarification process, companies will require technologies that facilitate robust integration of multiple steps," explained Nitin Naik, Transformational Health Global Vice President at Frost & Sullivan. "Commonly used technologies such as multi-stage depth filtration and tangential flow microfiltration that were retrofitted from legacy industrial applications (enzymes) are hindered by low reproducibility, capacity, and yield/loss. Therefore, the new technologies that are most likely to succeed will be the ones that provide predictable and high yields across product pipelines at different modalities."

Responding to the suggestion that traditional depth filters used in harvest processes may no longer be sufficient for upstream clarification, Alexei Voloshin, Global Application Strategy Specialist at 3M, agreed, stating, "The most interesting fact in purification processes is the reproducibility of chromatography. Every single time, assuming you get an input which is relatively consistent, you get an adequately consistent output."

3M has a wide range of innovative filtration and purification systems such as 3M™ Zeta Plus™ Depth Filter, 3M™ Emphaze™ AEX Hybrid Purifier, and 3M™ LifeASSURE™ Sterilizing Grade Filter. These solutions factor in the larger goals and initiatives of Global and European biopharmaceutical companies to introduce a truly disruptive solution and enable widespread implementation across various manufacturing setups.

3M has developed tools for unmet needs by ensuring that:

Its new solutions deliver a step change, as the investment and challenges associated with adopting new technologies and processes are significant.
The products are single-use/disposable, drug platforms-agnostic, scalable from lab scale through pilot to commercial scale, predictable as production scales up, and do not compromise yield.
The tools are future-proofed against evolving trends in mAb production and can achieve predictable reproducibility.
Substantial cost savings and a solid ROI for unit operations can be achieved.

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SOURCE Frost & Sullivan