Search results for " biologics"
Article
Ensuring the Quality of Biologicals
The development of this chapter has been performed in close collaboration with members of the EMA Committee for Advanced Therapies and the Biologics Working Party.
Thus, the existing Ph. Eur. mono…
Article
Critical Quality Attributes Challenge Biologics Development
While CQAs of small-molecule drugs can affect the purity, strength, drug release, and stability of a drug, the complex nature of biologics can create additional quality attributes that can affect the …
Article
Improving PAT for Biologics
“Real-time in-process measurements of critical quality and performance attributes of raw and in-process materials and processes are not always possible for biologics due to the complex nature of most …
Article
Impurity Testing of Biologic Drug Products
Then we have to consider what are now called the emerging techniques, at least for their application to complex biologics in an industry context, which in a couple of years will become as common as th…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
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
In these cases, many of the viral removal or inactivation technologies that are typically applied to “traditional” biologics will not work.
Generally, viral clearance methods for these processes r…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
…surfaces in contact with intermediates and the end product, Thibaud Stoll, global head of commercial biologics operations at Lonza, specifies.
For certain biologics, most notably viral vectors, v…
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…