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5,000L Single-use Bioreactors:The Next Generation in Biologics Manufacturing

The Thermo Fisher Scientific HyPerforma™ DynaDrive™ Single-Use Bioreactor line is suited for volumes ranging from 50L to 5,000L. Optimised for modern cell culture processes in a scalable, ergonomic design, the platform allows intensified, flexible manufacturing, enhanced by high-power input per volume, and better volumetric mass transfer performance.

This whitepaper highlights the features and benefits of the DynaDrive™ SUB platform and explains how any new or existing facility can leverage the platform to achieve expected development and manufacturing objectives. From pre-clinical trials through commercialisation, manufactures and companies looking to outsource their biologics can use the DynaDrive™ SUB to gain maximum efficiency and flexibility across a wide range of processes, cell lines, and molecules.

As scientific advancement in biopharmaceuticals continues to rise, so will the market. By 2030, total biologics revenues are expected to be worth $450 billion – up from the $285 billion biologics revenues seen in 2020. This rapid and continual growth has created a demand for therapeutics, expanding indications for biologics, and the growing portfolios of biosimilars. While these projections are good news for patients and makers of therapies, growth always comes with new challenges. In this case, the industry must learn how to deploy efficient, flexible manufacturing technologies that can respond to many variables. These variables include the proliferation of new biologics, rapid shifts in annual volumetric requirements, and improvements in cell culture strategies.

A new generation of single-use bioreactors (SUBs), built to deliver high-volume performance, addresses many of these issues. This innovation outperforms existing 2,000L SUBs that were once the only cost-effective alternative to stainless steel bioreactors.

Redesigned for Higher kLa Through Better Mixing Performance

Most SUBs with legacy designs have a single agitator attached to the top or bottom of the bag. Neither design mixes to a high degree of homogeneity, which can lead to product gradients and quality issues. The DynaDrive™ SUB, however, has a redesigned agitator shaft that spans the entire length of the bag – this new design contributes significantly to the technology’s reliable turndown ratio of up to 20:1.

Prior to the introduction of DynaDrive™ SUB, most turndown ratios on SUBs ranged from 2:1 to 5:1. Fast forward to today’s needs, many modern processes use higher producing cell lines and greater sophistication in process design. The need for greater oxygen transfer and mixing has become even more critical in process development.

One way to improve the oxygen transfer rate (OTR) is to increase agitation, thereby distributing gases more efficiently in a bioreactor. Many traditional SUBs, particularly at larger scales, are excessively challenged in terms of OTR for intensified processes and higher viable cell densities, making scale-up unfeasible.

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