Search results for " qualification"
Article
Transformative Medicines Challenge FDA and Manufacturers
And process scale-up further requires identification and qualification of thresholds and specifications.
Combos crucial
The process of developing and delivering cutting-edge gene therapies a…
Article
The New World of Biopharmaceutical Manufacturing
That might imply driving toward standardization from different perspectives: designs, interconnectivity, technical qualification packages, certificates, manufacturing practices, and product lifecycle …
Article
From Darwin to Recombinant Fc Multimers
R&D staff were then providing scientific support during equipment and process qualification, were involved in engineering batches to monitor manufacturing performance, and also contributed to the proc…
Article
Managing Residual Impurities During Downstream Processing
The standard provides information on the assay development cycle, development and characterization of HCP reagents, method development and qualification as fit for use, how to address dilution lineari…
Article
Single-use Bioreactors Have Reached the Big Time
“Single-use bioreactors such as the iCELLis allow rapid process qualification, implementation, and commercialization, providing the speed-to-market that next-generation biologic manufacturers need,” s…
Article
Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
While sometimes perceived as costly, these ready-to-use products minimize the need for hardware qualification and cleaning validation, which can be rather costly and timeconsuming for biomanufacturers…
Article
Managing Risk in Raw Material Sourcing
In light of the heparin, melamine, and other supply-chain disasters of recent years, there is more pressure than ever for pharmaceutical manufacturers to develop better supplier qualification practice…
Poster
Scale-up and process economy calculations of a dAb purification process using ready-to-use products
As less time is spent on equipment qualification and maintenance with these products, annual process time can be reduced by 3000 work hours, corresponding to two full-time equivalents (FTEs) per year …
Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
A combined approach of NIR and MVDA was used for the identification and qualification of basal medium powder components (9) and was evaluated as an identity tool for cell-culture media (10).
Raman…