Search results for " biologic" in Articles / App Notes
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
Process Chromatography: Continuous Optimization
Challener
Cell-culture and fermentation are high-yielding processes that effectively produce complex biologic molecules with desirable bioactivities. Even so, there are many impurities presen…
Article
Single-use Bioreactors Have Reached the Big Time
Commercial choice
As such, Norris sees single-use bioreactor processes designed with the entire workflow in mind, delivering a high quality, optimal biologic titer into the downstream unit operati…
Article
Moving Biosimilars Forward in a Hesitant Market
However, it is not the same when dealing with biologics because biologics are larger and more complex molecules. Thus, to show that a product is exactly similar, that it would have the same potency, t…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
One approach that potentially offers the benefit of a “cleaner” biologic product in upstream processing is the use of cell-free expression systems. By producing less waste upstream, there is the poten…