Search results for "biologic"
Article
Ensuring the Quality of Biologicals
… it also plays a vital role in providing quality standards for medicinal products and substances of biological origin. Biologicals are those products derived from biological sources such as tissues a…
Article
Critical Quality Attributes Challenge Biologics Development
The International Council for Harmonization (ICH) Q8 (R2) defines CQAs as “a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, r…
Article
Improving PAT for Biologics
…ogy (PAT) for ongoing monitoring and adjustment of production processes to ensure the production of biologic APIs with consistent quality that meet specifications every time. Implementing PAT for bio…
Article
Impurity Testing of Biologic Drug Products
They can also be identified as a sub-form of the therapeutic protein, possessing a biological activity either higher or lower than the one of the drug product.”
The second type of impurit…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
On a therapeutic protein, the composition of these glycans can significantly impact the drug’s stability, pharmacokinetics, and biological activity. Thus, glycan structure is a critical quality attrib…
Article
Modular Manufacturing Platforms for Biologics
…can take three to seven years to complete, its possible for a modular facility for oral solid dose, biologics bulk, or aseptic filling to be built in only 12 months from project start to operational …
Article
Updating Viral Clearance for New Biologic Modalities
For most traditional biological products, viral removal is theoretical—in part, because infectious virus is not usually present in the production process, says James Berrie, PhD, technical director, L…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
While this approach sounds like a practical approach to accelerating vaccine manufacturing, rapid changeover of biologic production process carries numerous challenges. There are a few different strat…
Article
A Look into Biologic Scale-Up Strategies
Optimizing cell-culture processes for monoclonal antibody (mAb) production is a key factor in scaling up manufacturing to commercial levels. To maximize cell-culture output, strategy is requir…
Article
Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
FDA approved 17 biologics out of a total of 59 drugs—the highest number to date.
This article will delve into why the pharma industry is heading toward a biologics revolution, what challenge…