In this success story, we provide an overview of the application of our products at one of our major customers from process development to GMP production using the example of a mAb process .
Automated sampling with Numera® as a central hub along a continuous bioprocess, enabling advanced real-time monitoring and process wide-control.
This article introduces the Lucullus® installation at Teva and highlights the workflow improvements through centralized process and data management.
Vaccines are one of the most effective, cost-efficient, and sustainable ways of controlling infectious diseases and have had a significant impact on public health and longevity as well as intensive livestock production.
The demand for vaccines, cell and gene therapeutics, and generally biologic manufacturing has continuously increased over the past decade.
In the “microbial drugs” department at the Helmholtz Center for Infection Research (HZI) in Braunschweig Germany, a high-tech laboratory environment was built embracing the bioprocessing 4.0 cornerstones.
Bioprocessing 4.0, the biopharmaceutical version of Industry 4.0, is defined as the digital transformation and automation of biopharmaceutical processes with the aim to drive manufacturing ...
Bioprocess laboratories with multiple lab-scale bioreactors often execute cultivation experiments in parallel with varying process parameters for process development and optimization purposes.
Every biopharmaceutical process aims for real-time monitoring and control of critical process parameters to minimize process variability and at the same time ensure predefined product quality.
A recently published article in the Journal of Chromatography A (Volume 1672, 7 June 2022, 463067; available online from April 15, 2022) shows that on-line monitoring of quality attributes (QAs) directly within the bioreactor can provide ...
Securecell AG has released a new version of Lucullus PIMS. This latest update called version 3.11 comes with many new features, focusing on a faster and easier user experience, with many functions brought to a higher level, ...
Vaccines based on messenger RNA (mRNA) gained awareness during the COVID-19 pandemic. This novel alternative to conventional vaccines is emerging for several reasons: on the one hand, mRNA vaccines only ...
Automated bioprocess systems rely on accurate online measurements of cellular growth. In the present study, six sensors representing five different technologies, namely near-infrared absorbance, ....
Bioprocessing 4.0 is all about digitalization and how it can streamline the analysis and multidirectional communication of data—be it between equipment, among unit operations, or across groups and stages of development.
The world population is expected to reach 9.6 billion people by 2050, the middle class is growing, and meat consumption is expected to increase by 70%. Meat production requires a great amount of resources: 34 kgs of feed are necessary to produce 1 kg of meat, the same kg of meat requires ca..
Pharmaceuticals have a prominent role in healthcare and their manufacturing requires innovative tools, scientific and engineering knowledge, and must at the same time comply with strict regulations.
The design space of bioprocesses strongly depends on the technological limits of a system. Digitalization helps to push these boundaries and reach new optimization. A vivid example of this technical extension is the use of additional PAT tools to monitor and control bioprocesses.
Securecell offers a complete automated 24/7 device for sampling and sample processing to “close the loop” between analytics and process units. Discover in this GEN tech article how Numera® can dramatically implement productivity in biopharma process development.
Cheese is Switzerland’s most important agricultural-export product: around 170’000 tons of cheese are produced per year (40% of the total Swiss milk amount) with a value of around CHF 600 million. Agroscope, a federal research institute in Liebefeld, near Bern, Switzerland ....
At Technische Universität Wien an innovative laboratory develops and optimizes a wide variety of bioprocesses; those operations require multiple bioreactors and equipment and produce an incredible amount of data.
Process control is a central task in bioprocess development and production. Apart from common control tasks including pH, temperature or dissolved oxygen, more advanced control tasks must be mastered.
Monitoring and control of critical process parameters (CPPs) in various bioprocesses is a prerequisite to gain a safe product and hence, is a major topic in Process Analytical Technology (PAT).
Timely monitoring and control of critical process parameters and product attributes are still the basic tasks in bioprocess development. The current trend of automation and digitization in bioprocess technology targets ...
In healthy people, pancreas regulates blood glucose in such a way that it is practically always within the target range. The so-called “time in range” (% of the time in 24 hours during which the blood ...
In discussions with analysts and potential investors, we occasionally hear the argument that there is no relevant need for the Seraccess Diabetes Care project, “because Novartis (Alcon) and Google (Verily) are on the way to solving the problem.”
HPLC is the common reference method for product and metabolite analysis in bio-processes. Sampling is needed for these analyses, resulting in off-line measure-ments along the process.
This application note presents two unique PAT tools, which can be used separately or together as an integrated PAT solution. The Numera system enables automated sampling, sample preparation, ...
Critical process parameters (CPPs) such as glucose must be monitored and con-trolled in every bioprocess in order to reach the desired product quality in the most efficient way.
To facilitate optimal process control limiting substrates must be identified, monitored and controlled. Amino acids are often critical substances, especially in mammalian processes.
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