Search results for " laboratory"
Article
Host-Cell Protein Measurement and Control
…r appropriate cell lines” … “Clearance studies, which could include spiking experiments at the laboratory scale, to demonstrate the removal of cell substrate-derived impurities such as nucleic acids …
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
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Climate Change in Outsourcing
Announcements of plant and laboratory closures, layoffs, and narrowed therapeutic focus still occur almost monthly, and it doesn’t look like they will end any time soon.
In recent years, the globa…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
More companies are implementing electronic laboratory notebooks, which have advantages over traditional laboratory notebooks such as ease of data sharing and collaboration, streamlined review and witn…
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The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compl…
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Quality by design for biotechnology products—part 1
Prior product knowledge plays a key role in the risk assessment and consists of the accumulated laboratory, nonclinical, and clinical experience for any specific product quality attribute. It also can…
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Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
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Evaluating the Use of Continuous Chromatography
However, despite successful laboratory trials, it has remained difficult to achieve continuous downstream processing at commercial manufacturing scale.
Perhaps another challenging aspect with cont…
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Manufacturing mRNA for research and beyond
This eBook guides you in the practical aspects of setting up an mRNA research laboratory. Get insights on methods, materials, and workflows for mRNA synthesis and scale up.
Explore the mRNA…
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Optimizing your Cell Culture Process to Improve Productivity
These companies cannot afford the set up and support an analytical testing laboratory. It can be expensive to purchase instrumentation and the capital expenditure. It is also necessary to train chemis…