Status and future of recombinant adeno‐associated virus vector manufacturing
Abstract Sixty years of adeno‐associated virus (AAV) research illustrates a trajectory marked by basic science exploration, iterative innovation, persistent challenges, a number of clinical setbacks, as well as commercial therapeutic triumphs. This continual evolution has led to recombinant AAV (rAAV) becoming a cornerstone of modern gene therapy ...
Frank Agbogbo, David Dismuke
wiley +1 more source
Scaled up fed-batch production of recombinant alpha-1-antitrypsin by CHO cells in single-use surface aerated orbital shaken bioreactor. [PDF]
Tang WQ +6 more
europepmc +1 more source
Abstract Maintaining consistent quality in the manufacturing of biotherapeutic proteins in mammalian cell culture is challenging, with unplanned deviations causing inconsistencies and potential batch failure. Current methods for monitoring and controlling critical process parameters (CPPs) rely on slow, labor‐intensive offline analyses.
Matthew Banner +12 more
wiley +1 more source
Optimization of cultivation strategies for production of recombinant human papillomavirus type 58 major capsid protein L1 in Hansenula polymorpha. [PDF]
Kopitak N +8 more
europepmc +1 more source
Scalable catalyst production process for oleate hydratase whole‐cell biocatalysis
This study establishes a scalable lactose‐induced fed‐batch fermentation for an Escherichia coli whole‐cell biocatalyst containing an oleate hydratase. Operation at a higher growth rate markedly increased biomass yields while maintaining catalyst activity and was demonstrated at 150 L scale.
Rebekka Horstmann +6 more
wiley +1 more source
Engineered Bacillus subtilis for high-yield nattokinase production and therapeutic potential in obesity management. [PDF]
Liu Y +5 more
europepmc +1 more source
Abstract High performance countercurrent membrane purification (HPCMP) has emerged as a promising diffusive separation strategy for the purification of recombinant proteins and monoclonal antibodies (mAbs). However, prior studies employed dialysis membranes, which are designed for diffusive separations but have not been validated for biopharmaceutical ...
Aylin Mohammadzadehmarandi +8 more
wiley +1 more source
Microbial Oil Production by <i>Yarrowia lipolytica</i> Under Semi-Continuous Cultivation and Potential Utility of Spent Supernatant. [PDF]
Uğur Ş +4 more
europepmc +1 more source
Abstract Development of therapeutic bispecific antibodies (BsAbs) poses significant manufacturability challenges associated with correct chain pairing and an increased diversity of impurities. Here we address this with a product quality assessment during cell line development (CLD), forgoing the need for genetic characterization during cell line ...
Molly Robinson +7 more
wiley +1 more source
A Hybrid Modeling Framework for Predictive Digital Twins of CHO Cell Culture. [PDF]
Richelle A +6 more
europepmc +1 more source

