Monoclonal antibodies (mAbs) are among the fastest-growing therapeutics and are being developed for a broad range of indications, from cancer to infectious diseases to cardiovascular……
Many factors influence the choice of expression system for production of recombinant proteins. These include the complexity of the target protein, the intended use of the product, an……
Continuous perfusion cell culture has been well established for many years in the production of biologics. In the past, this production mode was most desirable for labile products th……
Continuous and semicontinuous processes have been practiced in many industries for decades. Prime examples are steel, paper, and automobile production. These industries are all very ……
Process intensification, as defined here, is the desire to improve productivity (grams/L/h or grams/gram resin-hr or plant productivity in grams/plant-h). Intensification of a produc……
Cleaning validation is an area that demands considerable attention and often leads to negative comments during regulatory inspections. It has been suggested that for biotech products……
Manufacturing processes for biotherapeutics and vaccines require efficient cleaning, sanitization, and sterilization procedures to guarantee product safety. Such procedures are an in……
Immunoglobulin G (IgG) is the most abundant antibody class in human serum, accounting for approximately 70%–85% of total serum immunoglobulins, and plays a central role in adaptive ……
Against the backdrop of booming biopharmaceutical development, prefilled syringes have emerged as the preferred delivery system for innovative formulations including monoclonal anti……
If mRNA drugs are likened to confidential life instructions sent to the inside of cells, lipid nanoparticles (LNPs) act as an elite escort team safeguarding these messages through n……
In the field of lipid-based drug delivery, LNPs (Lipid Nanoparticles) and liposomes are two widely discussed yet frequently confused concepts. Many people mistake them for the same ……
In the delivery journey of mRNA-LNP therapeutics, particle size stands as a critical parameter that determines success or failure. Unlike mRNA, which carries genetic instructions, o……
mRNA vaccines feature rapid production and robust process versatility, conferring unparalleled advantages in responding to emergent public health epidemics. The successful deploymen……
Production efficiency, product quality and cost control are the core competitive factors in the biopharmaceutical industry. Cell perfusion culture, an advanced bioprocess solution, ……
With mass of the antibody and its concentration known at any stage in the process, sizing of a chromatography column can be performed based on both chromatographic and non-chromatogr……
With the scale of operation for the upstream chosen to fulfil the mass demand per batch/campaign, the scaling up of a downstream process becomes the next task. Taking as an example a……
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