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| home > white papers > The Importance of ADCC in Assessing Clinically Relevant Differences - Sartorius Stedim BioOutsource Ltd |
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 WHITE PAPERS |
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Sartorius Stedim BioOutsource Ltd
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The Importance of ADCC in Assessing Clinically Relevant Differences
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Biosimilars have caused a revolution in the development of biologic
drugs. The model for biosimilars is a combination of speed to market and
low cost; these are fundamental to any biosimilar development project.
The biosimilars pathway to approval is not always without difficulty,
biosimilars are still relatively new, and as each new applicant is
reviewed we are learning more and more about these molecules.
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News and Press Releases |
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Turkish Cargo maintains its dual-terminal operations seamlessly
Completing the gradual transition process to Istanbul Airport, one of the largest airports of the world, the global air cargo brand Turkish Cargo maintains its dual-terminal operations with full capacity on 7/24 basis without any sales restriction.
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White Papers |
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Cleaning Validation: What do you need to consider to ensure a successful outcome?
RSSL
Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination.
The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support.
The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues.
So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
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Industry Events |
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Clinical Trial Supply Europe
11-12 March 2020, Madrid, Spain
The 21st annual edition promises to grow on the success of 2019’s excellent conference which saw delegates from Europe’s largest pharmaceutical companies and biotech innovators come together to discuss, debate and unpack the latest trends in clinical supply chain innovation. 2020 will offer delegates the opportunity to address the growing need for agility within the supply chain in response to increasingly complex trial demands. With a stream dedicated to supply operations and another to innovative uses of technology in the supply chain, delegates will get the chance to gain practical take-aways that they can apply to their own studies.
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