CultureOne: Questions and answers

Alfa Laval experts answer common questions about the CultureOne separation platform and its unique potential.

Ask our biopharma separation experts

Our team has years of experience working with single-use biopharma process in every corner of the globe. They understand the unique needs and challenges of this industry. Contact us today and let us help you achieve your biopharma goals.

With Alfa Laval, you can safely migrate from our stainless-steel separators to our single-use separators with the CultureOne range. Whether you need a pilot plant or GMP production, we have a range that covers all your needs in single-use cell harvesting. 

Existing single-use technologies with filters have reached limits due to increased batch sizes and cell densities. Alfa Laval's CultureOne range reduces the need for filters by up to 50-80%, offering a scalable solution that continues to minimize the ecological footprint even as demands grow. This means you can save money, resources, and waste material with the CultureOne. 

The CultureOne machine is a small, stand-alone, and easy to setup device that can help you do experiments in almost any environment. We have a great cooperation with universities and national innovation initiatives, like GeneNova. 

How does CultureOne ensure data integrity and connectivity?

You can choose between standalone or centralized system, with suitable levels for monitor and control. You can enjoy open software, which ensures full accessibility to connect data historian or DCS. You can develop customized software to run on platforms. You can also achieve data integrity with complete compliance 21 CFR Part 11. 

What makes CultureOne a good choice for reducing water use, energy use, and cleaning chemicals?

Traditional pharmaceutical production requires significant water and chemicals for cleanliness. Single-use systems reduce these needs but still require utility water and chemicals. The CultureOne range eliminates the need for flushing and chemicals, reducing utility fluid usage and waste material by up to 80%. This makes CultureOne an efficient and environmentally friendly choice.

CultureOne can handle large batches and high cell densities. This range offers you an adaptable high-capacity solution that can process over 200 million cells per milliliter and up to 700 liters per hour. This means you can save time and money as you scale up your biopharma process.

The Alfa Laval CultureOne centrifuge range can make your validation, qualification and GMP production easier. You can get Alfa Laval’s expert support, standardized commissioning tests, and mechanical training and commissioning. 

How does CultureOne contribute to real scalability in biopharma processing?

When Alfa Laval customers examine harvest techniques, scalability across the product range is crucial. With CultureOne, we demonstrate this by running side-by-side trials of Primo and Maxi machines, achieving consistent results. This predictability ensures customers receive superior separation results from batch to batch, regardless of scale. CultureOne offers seamless scalability from Primo to Maxi and compatibility with traditional stainless steel separators, delivering exceptional performance at every scale of biopharmaceutical processing

 

 

How does CultureOne meet GMP production requirements?

GMP production stands for Good Manufacturing Practice, ensuring safe and reliable production of human biotherapeutics. Alfa Laval meets these stringent standards with the CultureOne system, using familiar materials and rigorously tested proprietary designs. This guarantees our customers a reliable solution for producing biotherapeutics safely and effectively.

 

How Does CultureOne Deliver Superior Performance with a Small Footprint?

Alfa Laval designed the CultureOne family to be compact, fitting seamlessly into typical manufacturing environments. Despite its small size, CultureOne Primo and Maxi deliver exceptional separation performance. The CultureOne range combines a small footprint with superior efficiency, ensuring outstanding separation results.

Know more about CultureOne

With CultureOne separators, you can get the most out of your harvested product. Our separators deliver higher product yields than other single-use technology, with yields up to 99%.

CultureOne Range - ready for production today