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Upstream Bioprocessing
From Pre-clinical to Manufacturing


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Accelerate Your Process Development

Maximize Productivity

Meet Quality Requirements

Simplify Operations


Scale Up

Prevent Contaminants



Maximize Productivity

At the earliest stages of clinical development, it may be tempting to get to the clinic as quickly as possible at the expense of process development efficiency. This strategy is likely to result in a poorly developed process that is not amenable to later stages of development when scale-up is necessary.



Cell Line Development

Select the right cell line, the first time

How to generate a high-performing cell line on a reduced timeline?

Key considerations when choosing a cell line as the expression platform include:

  • Selecting a single-cell clone that can produce the biologic of interest.
  • Generating a clone from that cell line that can produce the biologic at high productivity/titer and high protein quality.
  • Ensuring successful scale-up with a robust cell line.



Process Development

Increase productivity with an optimized media and feed strategy (Fed-batch)

The best feeding strategy is crucial to achieve high cellular growth while maintaining high specific productivity. Optimization of feed volumes and timing of feed administration should be empirically determined on a process- and cell-line specific basis to maximize performance.



Screen, select, and optimize the right media

The quest for a viable industrial biotechnology process generally starts with the generation of a cell line expressing the protein of interest, and the selection and optimization of the right cell culture media & feed.

Media screening, media optimization, and nutrient testing can help you find and optimize the right media and feed for your cell line. Leverage high throughput (HTP) and Design of Experiment (DOE) approaches by partnering with experts from our R&D team and expedite simultaneous screenings.




Production

Intensify seed trains with an optimized expansion medium

High cell densities and low CSPR

Intensify seed trains with an optimized expansion medium

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Enhanced perfused seed trains at N-1 enable the spiking of the production bioreactor with a higher quantity of cells, reducing the time needed to reach the desired level of protein production, ultimately increasing plant outputs and bioreactor flexibility. Specially designed cell culture media for perfused seed train cell expansion allow for spiking the production bioreactor with higher cell densities.



Achieve higher productivity with perfusion processing

Video: Tech Talks - Voice of the Expert: Perfusion and intensified fed-batch

Use of perfusion mode of operation is becoming more widely adopted in bioprocessing. A perfused seed train can save time, reduces bioreactor size and reduces footprint in the seed train. Production perfusion processing delivers higher protein yields when compared with fed-batch and requires specifically-designed type of medium to facilitate high productivity at low perfusion rates. EX-CELL® Advanced HD Perfusion Medium meets such manufacturing requirements.



Overcome issues with insoluble or unstable amino acids

Video: Simplification of fed-batch processes using modified amino acids

The essential amino acids tyrosine and cysteine are a challenge when used in upstream processing due to low solubility (tyrosine) and low stability (cysteine) at neutral pH. To simplify fed batch processes and enable high available concentrations of both amino acids, we offer chemically-modified tyrosine and cysteine, enabling a single feed strategy at neutral pH.

We also offer Cellvento® 4Feed, a single high concentrated feed that allows the reduction of feed volume, increasing the volumetric productivity. It includes derivatives of tyrosine and cysteine, is added at neutral pH, simplifying feed addition.



Ensure lot-to-lot consistency

Lack of consistency in raw materials can create significant variation in upstream processes, causing unexpected loss of cell density and viability, and ultimately, loss of yield. A better understanding of your raw materials increases your ability to control process variabilities.