SwiftScale Biologics: Cell-Free Synthesis of Biologics

insights from industryDavid MaceChief Executive OfficerSwiftScale Biologics

In this interview, News-Medical talks to David Mace, Chief Executive Officer at SwiftScale Biologics, about the work they do and how their partnership with Sartorius benefits both parties

Please could you give an overview of SwiftScale, the work you do and your partnership with Sartorius?

We are a CDMO focused on clinical-scale biologics manufacturing via cell-free protein synthesis. Cell-free protein synthesis enables faster, cheaper scaleup from DNA to clinical batches. We are grateful for our relationship with Sartorius; they supply many of our single-use bioprocessing components for our facility.

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Why do therapeutics generally take such a long time to get to market?

In the process of scaling up from DNA sequence to human protein doses, there are several drivers of time and cost. In general, batch iteration speed is vital because it dictates the level of optimization that can be performed on the protein synthesis and purification conditions.

How do cell-free synthesis systems such as SwiftScale’s decrease the development length of therapeutics?

In cell-free protein synthesis, each iteration in scaling up the production process from lab to clinical batches takes on the order of 16 hours. This reduces cycle times, labor and facility utilization which all enable a better cost and timeframe.

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Aside from quicker development, what other advantages does the system provide?

Batch-to-batch consistency is vital in clinical and commercial therapeutic production. One advantage of cell-free protein synthesis is that a process with no living components provides an extreme level of batch-to-batch consistency, even across varying scales.

How does your partnership with Sartorius help SwiftScale on a day-to-day basis?

It is especially vital to have high quality bioprocessing components when bringing a non-traditional manufacturing process online. Being able to trust the quality of Sartorius’ bioprocessing components enables us to focus on our process.

Process consistency is vital and is a large advantage of cell-free synthesis, but that consistency is only as good as the bioprocessing components leveraged in the biomanufacturing process.

What have been some of the main challenges that SwiftScale have encountered?

To scale any innovative technology like cell-free requires leveraging existing workflows and equipment. To ensure scalability of cell-free to commercial scale, we use standard equipment and bioprocessing components from vendors like Sartorius.

Scaling is a much simpler challenge because Sartorius’ bioprocessing product suite spans many scales and already has well-characterized performance at those various scales.

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What does the future hold for SwiftScale, their partnership with Sartorius and the therapeutic development field?

Our mission is to scale up 100 drugs per year for partners. We are early on that mission, but we are confident that our technology changes the time and cost equation by such a degree that this goal is achievable. We are thrilled to continue working with Sartorius’ high quality products as we continue our expansion.

Where can readers find more information?

Here is a link: https://www.swiftscalebio.com/

Learn more about Incucyte and Sartorius cell and protein analysis solutions at www.sartorius.com/virology

About the Researcher

David Mace is the CEO of SwiftScale Biologics. He was previously an Entrepreneur in Residence at 8VC, a $3B asset fund in San Francisco. His career has spanned work in advancing novel technologies to commercialization. Prior to this, his studies were at Caltech.

About Sartorius

Sartorius is a leading international pharmaceutical and laboratory equipment supplier. With our innovative products and services, we are helping our customers across the entire globe to implement their complex and quality-critical biomanufacturing and laboratory processes reliably and economically.

The Group companies are united under the roof of Sartorius AG, which is listed on the Frankfurt Stock Exchange and holds the majority stake in Sartorius Stedim Biotech S.A. Quoted on the Paris Stock Exchange, this subgroup is comprised mainly of the Bioprocess Solutions Division.

Innovative technologies enable medical progress

A growing number of medications are biopharmaceuticals. These are produced using living cells in complex, lengthy and expensive procedures. The Bioprocess Solutions Division provides the essential products and technologies to accomplish this.

In fact, Sartorius has been pioneering and setting the standards for single-use products that are currently used throughout all biopharmaceutical manufacturing processes.

Making lab life easier

Lab work is complex and demanding: Despite repetitive analytical routines, lab staff must perform each step in a highly concentrated and careful way for accurate results.

The Lab Products and Services Division helps lab personnel excel because its products, such as laboratory balances, pipettes and lab consumables, minimize human error, simplify workflows and reduce physical workloads

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