Search results for " knowledge"
Article
Understanding Validation and Technical Transfer, Part 3
Without detailed knowledge of the current process and how it functions, it is impossible to assess the potential impact of any change. Therefore, it is important that the validation records and report…
Article
Leveraging Data for Better Biopharmaceutical Process Control
There’s a need to take knowledge of the process and use it to build a method, then to align the lifecycle of the method with that of the process through teamwork and collaboration.It’s much more than …
Article
Applying GMPs in Stages of Development
…hought when releasing product at any stage for human consumption is: are there adequate controls and knowledge to assure patient safety?
References
1. FDA, INDs for Phase 1 Studies of…
Article
Impurity Testing of Biologic Drug Products
Sadick and Merges (Catalent): The underpinning to this response is the knowledge that each protein therapeutic is quite different from any other protein therapeutic, whether in terms of its final tert…
Article
Platform Technologies Improve Protein Expression
Adds Voldborg: “Cellular expression systems are highly complex, and we still lack knowledge of the cellular machinery that is used to transcribe, translate, fold, modulate, and finally secrete desired…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
…cultures, a key disadvantage is the possibility of poor reproducibility originating from the lack of knowledge of the exact composition (4). Synthetic or chemically defined media are prepared by addi…
Article
Managing Residual Impurities During Downstream Processing
“As biologic manufacturing and biologic product knowledge continue to expand, there will be a constant requirement to adapt and amend both thought processes and guidance,” Wake states.
Role of publ…
Article
Unifying Continuous Biomanufacturing Operations
Gaps in vendor offerings and processing knowledge
The pilot plant described in the Klutz et al. study was designed to run using primarily single-use, disposable materials. Of these materials, 95% …
Article
Critical Quality Attributes Challenge Biologics Development
Challenges for biologics
BioPharm: Are there specific challenges to identifying CQAs in biologics when applying quality by design (QbD)?
Das (BMS): Knowledge-based design, as opposed to a heur…
Article
Managing Biomanufacturing Capacity Expectations
Wyss argues, however, that he does not expect excess capacity in-house to be used for the production of biosimilars too often: “To my knowledge, even pharma companies having both original products and…