Search results for " Phase III"
Article
A Plastic Pipeline for Commercial Bioprocessing?
She recommends that companies delay a decision on a platform until they have Phase III data to know what scale is needed.
Smaller companies with limited resources may not have regulatory staff…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Optimizing Late-Stage and Commercial Cell-Culture Processes
Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
By Feliza Mirasol
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Article
Single-Domain Antibodies for Brain Targeting
…bosis, oncology, and neurology with seven sdAb products in the clinic (three in Phase II and four in Phase III) (36, 37). BI 1034020 Nanobody is being developed in collaboration with Boehringer Ingel…
Article
Reimagining Affordable Biosimilars
A Phase III trial is a confirmatory study for evaluating biosimilarity with respect to safety and PK/PD (7,8). In most cases, these confirmatory studies cannot be powered to test for efficacy (5). Pos…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
The requirements for Phase I and Phase III products are different, and thus the risk assessment is a living document that should be adapted based on the status of a project, even if the process stays …
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Article
Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com
The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
…
Article
Moving PAT from Concept to Reality
Drug companies would like to start manufacturing process development later in the overall development cycle—preferably during Phase III of clinical trials—in order to focus their investments on candid…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …