Search results for " knowledge"
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
Article
FDA Seeks Metrics to Define Drug Quality
Firms generally consider metrics for contractors similar to those applied internally, but also weigh supply-chain security, sterility assurance, and product and process knowledge.
Boosting capacit…
Article
Elucidating Biosimilars Characterization
Pharmacokinetic profile and safety testing of a biosimilar medicine, with the knowledge that this product has been well-characterized and determined to be highly similar to the originator medicine, ne…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Implementing high-throughput and multi-product liquid chromatography methods that use available knowledge and resources typical in a biopharmaceutical facility can address the increasing demand for pr…
Article
PDA's Technical Report for Biotech Cleaning Validation
With the knowledge of large-scale equipment, one can create an approach that results in a successful cleaning validation.
Cleaning validation plays an important role in reducing the possibility of p…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
…ecently been published that describes extensive use of scale-down models to gain process and product knowledge (50). However, significant data from scale-down models could be used to define the desig…
Resource
American Society of Mechanical Engineers
The American Society of Mechanical Engineers (ASME) is a not-for-profit membership organization that enables collaboration, knowledge sharing, career enrichment, and skills development across all en…