Pharma & Biotech

Recombinant proteins are engineered proteins produced by genetically modified cells and play a vital role in therapeutics, diagnostics, and research due to their specificity and scalability. Examples of cell lines commonly used to produce recombinant proteins include CHO (Chinese Hamster Ovary), HEK293, Vero, and Sf9 cells, among others. Traditional single-use technologies like depth filters and centrifuges often face challenges with high-density cultures and large batch volumes. The FUNDALOOP® single-use filter enables efficient clarification through cyclical cake filtration, delivering excellent product recovery, high filtrate clarity, and reduced filter area 
requirements. Its fully enclosed, disposable design minimizes contamination risk, while heel volume filtration and back-flush steps increase yield and reduce waste. Scalable from lab to production scale, the FUNDALOOP® offers a robust alternative to traditional cell harvest methods.

Viral vectors have become an essential tool in modern therapeutics, especially with the rapid advancement of gene therapy. These vectors, such as AAV, LV, or AV, are commonly produced in HEK293 cells, which are lysed during harvesting to release the viral particles. This process can be challenging at the harvest stage, as vectors have relatively low titers, high shear sensitivity, and are commonly lysed, resulting in smaller, harder-to-capture particles. Additionally, viral vector manufacturing demands strict control over purity and sterility throughout the process. The FUNDALOOP® system supports efficient clarification of viral vector–
containing cultures by removing host cell debris while preserving the 
integrity of sensitive viral particles. Its fully enclosed, single-use design 
reduces contamination risk and offers scale up flexibility from clinical to 
commercial-scale operations.

Monoclonal antibodies (mAbs) are one of the most widely used and commercially successful therapeutic modalities in modern medicine. Their popularity has grown steadily over the past few decades due to their high specificity, versatility, and proven clinical efficacy across a broad range of diseases. mAbs are typically grown in mammalian cell lines that can achieve very high densities, posing a problem for proceeding separation steps. The FUNDALOOP® is able to self-clean its filter cloth with a patented backflush step, regenerating the filter media to its full capacity and prolonging the lifespan of each filter bag, saving both time and money while reducing plastic waste.

Microbial fermentations are a cost-effective way to produce biopharmaceutical compounds such as plasmids, antibody fragments, vaccines, enzymes, and other recombinant proteins. However, they come with their own unique challenges, as the high biomass and fine particulates can rapidly clog filters. The FUNDALOOP® offers a closed, single-use solution that replaces traditional centrifugation and depth filtration steps. Its cyclic filtration 
process, with integrated backflushing, maintains high flow rates and prevents fouling, allowing for multiple runs on a single filter module. This improves reduces downtime, plastic waste, and cost during processing of 
bacterial or fungal biomass. We have also found that the addition of flocculants works well with the FUNDALOOP®, especially when dealing with extremely high-density, difficult-to-filter broths.

Media, reagent, and buffer preparation can be a highly complex process that often requires sterility. Dissolving powders and raw materials in solution can pose challenges with agglomerates, dead zones, and foaming, and gentle yet effective mixing is essential. The FUNDAMIX® system works by vibrational technology, offering much lower shear rates and energy consumption compared to mixers with impellers while maintaining efficient homogenization. The amplitude and frequency of the vibrations can be adjusted and controlled to suit each individual application. The FUNDAMIX® is available in a single-use version for highly controlled processes where sterility 
is paramount, as well as stainless steel versions which can be incorporated in CIP/SIP compatible skids for GMP-compliant 
processes.

The FUNDAMIX® is an ideal mixing solution for sterile vial filling applications, where consistent concentration and complete homogeneity in the mixing tank are critical to ensure accurate dosing in every vial. Its highly efficient vibrational mixing technology reduces dead zones and rapidly achieves uniformity throughout the entire volume, even as the tank empties. A low heel volume is achieved by positioning of the mixing plate near 
the bottom of the SS tank or mixing bag. As the oscillating design is free from any rotating parts, there is also no need for mechanical seals and no vortex formation. Available in both single-use and stainless steel configurations, the FUNDAMIX® provides a gentle, energy-efficient solution for high-purity pharmaceutical filling processes.

Cold plasma fractionation is a process that isolates valuable proteins from blood plasma by gradually adjusting temperature and pH through the addition of ethanol and octanoic acid. Inconsistent mixing during this process can lead to incomplete or inaccurate protein precipitation, reducing both yield and purity. FUNDAMIX®, offered in both single-use and stainless steel options, provides a solution with its gentle, low-shear mixing technology that ensures rapid and uniform dispersion of additives throughout the batch. Its design allows direct dosing 
into the mixing flow, preventing local pH variations and protecting sensitive protein structures. This results in a more efficient, eliable, and high-quality production process when preparing albumin and other fractionation proteins.