Results 231 to 240 of about 158,711 (303)

A case study showing the role of hydrophobicity variants and other enriched mAb proteoforms on filterability through a virus filter with productivity improvement measures

open access: yesBiotechnology Progress, EarlyView.
Abstract A rapid assessment of manufacturability for drug candidates is crucial for advancing a prospective biotherapeutic from a candidate to a bulk drug substance. A lot‐to‐lot approach to manufacturability is adopted where each biologic batch is assessed for manufacturability as a bulk, unfractionated pool.
Solomon Isu   +6 more
wiley   +1 more source

Performance of large virus removal filters during AAV processing: Influence of flux and process disruptions

open access: yesBiotechnology Progress, EarlyView.
Abstract As adeno‐associated viral vectors (AAV) continue to advance through the clinical pipeline, effective downstream purification strategies must be developed to ensure bulk drug purity and safety. AAV are produced within mammalian cells, bringing forth risks associated with viral contamination.
Akshay S. Chaubal   +5 more
wiley   +1 more source

Innovative methodology for flexible monitoring of various bioprocesses by using pre‐existing Raman data coupled with automated transfer learning technique

open access: yesBiotechnology Progress, EarlyView.
The application of the transfer learning algorithm successfully allowed the use of a model built on process A for real‐time monitoring of process B. This study shows the improvement obtained with this methodology compared to the direct application of the model.
Adèle Schini   +7 more
wiley   +1 more source

Evaluation of drug causality in SJS/TEN: The role of the lymphocyte transformation test and conventional/modified IFN-γ ELISpot assays. [PDF]

open access: yesWorld Allergy Organ J
Soliman MH   +7 more
europepmc   +1 more source

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