Monoclonal Antibody Therapeutics to Drive the Biotherapeutics Market

Pharmaceutical manufacturing operations call for new technologies to solve challenges in the harvest, clarification, and purification processes of mAbs production, finds Frost & Sullivan

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Frost & Sullivan

Sep 04, 2019, 07:12 ET

SANTA CLARA, Calif., Sept. 4, 2019 /PRNewswire/ -- The class of monoclonal antibody (mAb) therapeutics has grown considerably in the past two decades and now makes up a significant portion of the biotherapeutics market. Pharmaceutical manufacturing operations continue to adjust to the increasing demand, particularly around the processes of harvest, clarification, and purification of mAbs. Several challenges in current harvest operations are necessitating changes in techniques and technologies. The industry is moving away from conventional centrifugation given its ineffectiveness with increasing cell biomass, high cell densities, and high titres stemming from these new cell culture processes. Additionally, the high capital cost and significant maintenance and cleaning required for centrifugation make the technology a prime target for replacement.

Frost & Sullivan Perspective on Next Generation Harvest Techniques offers insights into challenges, strategies, techniques, and barriers to new technology implementation in mAb therapeutics production. The primary goals for harvest and clarification operations are to remove cells and cell debris from mammalian cell culture and further purify and clarify the resulting product to capture the mAbs via chromatography downstream.

To download the complimentary executive summary, please visit: www.frost.com/nextgenharvest.

"In terms of industry needs, at the most basic level, new technologies must make a step change in advancement to be implemented given the investment and challenges associated with adopting new technology and changing processes," noted Christi Bird, Life Sciences Principal Consultant at Frost & Sullivan. "In terms of the products themselves, demand exists for technologies that are single use/disposable, universal across various drug platforms, scalable from pilot to commercial scale, predictable as production scales up, do not sacrifice yield, can accommodate expectations for future trends in mAb production, and achieve predictable reproducibility."

"From the supplier perspective, 3M is looking into the harvest space as an opportunity to develop technologies that are purpose-made for the industry, given current solutions are borrowed from other applications and simply not ideal given so many challenges," explained Alexei Voloshin, Global Applications Engineering Manager at 3M. "None of the technologies that are widely used today, neither depth filtration nor centrifugation, were specifically designed for biopharmaceutical manufacturing. In fact, both of these technologies and principles have migrated from other industries, such as industrial fluid clarification and small-molecule API separation. We are investigating what new technologies and separation principles that are best suited specifically for this industry and offer performance and robustness that our customers expect from the next-generation platforms."

While harvest and purification unit operations adjust to these new challenges internally, there is an opportunity for technology developers to create solutions for these unmet needs.

Product development risks and market entry barriers are low, stoking tremendous opportunities for technology developers. The following industry conditions are creating a market ripe with growth opportunities:

Pharmaceutical manufacturing operations are calling for new technologies to solve challenges in the harvest, clarification, and purification processes of mAbs production.
Current technologies are not cost-effective given existing industry challenges; therefore, new solutions will have greater market penetration potential.
A willingness of industry experts to participate in discussions about technology needs and collaborate to solve challenges, rather than keep methods and solutions proprietary, creates a collaborative, forward-looking market atmosphere and stokes new ideas.
An eager potential customer base that is actively looking for solutions.

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SOURCE Frost & Sullivan