Search results for " biologic"
Article
Managing Residual Impurities During Downstream Processing
Challener
Manufacture of protein and other biologic drug substances via cell culture or fermentation occurs with the natural, simultaneous production of other unwanted materials, particularly host-…
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Unifying Continuous Biomanufacturing Operations
The most efficient upstream processing systems in biologics manufacturing seek to mimic the body’s treatment of cells, so a constant level of incoming nutrients and outgoing waste products is necessar…
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Reviewing the Importance of Biosimilarity and Interchangeability
The importance of biosimilar products is tied to the push for more affordable, accessible biological treatments. However, bringing a biosimilar to market has strict challenges because the biosimilar d…
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The Importance of Partnering for Bioanalytical Studies
By Feliza Mirasol
Bioanalytical studies are an important aspect in biologic drug development because data from these studies are needed to define the characteristics of potential new biologic …
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical industry by attacking disease using the mechanisms of the cell and immune system. These therapies are fragile…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes changed dramatically once it was discovered in 1996 that a fatal disease (variant Creut…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
…ws in one or more of the following, non-discrete categories of the research and publication process: biological reagents and reference materials, study design, laboratory protocols, and data analysis…
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Setting Standards for Biotech Therapeutics in India
With the ongoing shift from small molecules to biologics, the Indian biopharmaceutical industry is also set to replicate the success received by the Indian pharmaceutical companies (Figure 1B) (1). Th…
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Enhancing Resins Addresses Purification Concerns
Resins have been seen as one tool that can address the purification needs of new COVID-19 vaccines as well as the existing challenges in the downstream processing of increasingly complex biologic moda…
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An Analytical Approach to Biosimilar Drug Development
By Feliza Mirasol
The long-term safety and efficacy of biosimilars are largely based on clinical studies that have already been conducted on the reference biologic, but these studies may…