In the field of cell and gene therapy (CGT), high-quality plasmid DNA (pDNA) serves as an indispensable foundational raw material. Whether applied in viral vector manufacturing, in v……
Against the backdrop of the rapid commercialization of cell and gene therapy, lentiviral vectors (LVVs)—as critical gene delivery tools—are evolving from laboratory-scale methods to ……
In the broader landscape of biopharmaceutical manufacturing, downstream processing is responsible for extracting and purifying target biomolecules from complex cell culture broth. If……
Driven by the rapid advancement of gene therapy and cell therapy in recent years, lentiviral vectors have emerged as core tools for diverse therapeutic strategies owing to their capa……
Driven by the rapid advancement of mRNA vaccines, gene therapy and nucleic acid therapeutics, lipid nanoparticles (LNPs) have emerged as one of the most mature and industrially promi……
In the biopharmaceutical industry, successful scale-up of laboratory-scale cell culture processes to manufacturing scale represents a major technical bottleneck for the industrializa……
The biopharmaceutical industry focuses on developing complex biological products, while facing challenges including complex production processes, high capital equipment investment, a……
In the competitive landscape of antibody drug manufacturing, titer and quality are the dual pillars determining ultimate success. As the core production stage, mammalian cell culture……
With the increasingly severe situation of animal epidemic prevention and control, the viral veterinary vaccine industry is undergoing a qualitative transformation from scale expansio……
Recombinant Escherichia coli refers to engineered bacterial strains developed through genetic engineering technologies, in which exogenous target genes (derived from humans, other an……
Lactate metabolism serves as a core component in the development and optimization of cell culture processes, directly impacting cell growth, viability, and the yield and quality of t……
This article provides an in-depth discussion on Performance Qualification (PQ) and Process Performance Qualification (PPQ) for single-use systems. It focuses on how to ensure the con……
In the R&D system of cell and gene therapy (CGT), the quality control of raw materials, starting materials and excipients serves as the cornerstone of the entire industry. Unlike……
In industrial fermentation production, the judgment of the fermentation endpoint directly determines final product quality and economic benefits. Terminating fermentation prematurely……
We are standing at the dawn of a new era, the era of biopharmaceuticals, an era where scientific innovation reshapes healthcare boundaries, and life-saving technologies bring new hop……
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