In development of all pharma production processes, including hMAbs produced by CHO cells, decisions regarding the best parameters and methods are made based on cost, time, and titer comparisons.
When selecting a bioreactor, It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.
The adoption of disposable bioprocessing equipment has already been widespread for small-scale applications at the development and clinical manufacturing stages.
Analysts have estimated the failure rate of commercial laboratory information management systems (LIMS) to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.
Once protein purification work surpasses a certain scale in terms of volume, a measured and step-wise development of the bioseparation process is vital.
Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing. At the larger end of the scale, advances in upstream processing such as improved fermentation capacities have led to increased amounts of crude sample available for input. Despite this meaning higher potential yields of target proteins, it also poses an enormous challenge for timely and cost effective sample processing further downstream. This challenge is made even more difficult as scale increases due to higher amounts of impurities — a result of prolonged fermentation times and higher cell densities in large-scale cell cultures.
When it comes to downstream bioprocessing, we already have many of the technologies we require – we only need to focus on adapting them.
Whey proteins play a vital role in the formulation of food supplements because of numerous desirable nutritional and functional properties. This case study depicts the establishment of a process workflow for whey purification using Nuvia S and Nuvia Q Ion Exchange Resins.
With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.
How and why collaboration improves single-use products.
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