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SIMCA-online 16 now launched!

Get more value from your data by using the updated web client
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SIMCA-online 16 now launched!

Get more value from your data by using the updated web client
Learn more

quality by design for biosimilar development pharma

Biosimilars are an exciting route to increasing access to the highly effective therapy made possible by biologics, but ensuring a biosimilar meets the critical quality attributes (CQA) of the original biologic is a major challenge. Optimizing production at full scale is impractical, which makes a quality by design (QbD) approach using a reliable scale down model of the process an attractive alternative. A process development team at Zhejiang Hisun Pharmaceuticals, Taizhou, China, therefore developed a scaled down model of the cell culture process used to produce the biosimilar adalimumab. They qualified the model using multivariate data analysis (SIMCA), and explored the design space for key process attributes (KPA) and CQAs using MODDE.

12 Nov 2019

Boiler hero img

Optimizing the function of boilers, turbines and other capital equipment used to generate power requires a careful balance of fuel, heat, pressure, operator proficiency and many other variables. Managing the process on a day-to-day, or minute-to-minute basis, is like performing a skilled and well-orchestrated dance—partly based on data, but also based on operator expertise. Yet, adding more accurate information to the equation can potentially save millions of dollars, cut emissions significantly and even expand the working life of your equipment. 

28 Oct 2019
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Ease of use, MOCA and data merging are some of the new functionalities added to SIMCA 16

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Courses

10 Dec 2019
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Multivariate Data Analysis

2 days English
Malmö, Sweden
21 Jan 2020
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Design of Experiments

2 days English
Malmö, Sweden
11 Feb 2020
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Multivariate Data Analysis

2 days English
Malmö, Sweden
11 Feb 2020
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Batch Process Modelling...

2 days English
Bohemia, NY, USA

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IFPAC

Sunday, February 23, 2020 Washington D.C., USA

Process Analytical Technology is one of the most exciting and important advanced technology areas meeting both the current...Read more

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