Insight I Sino Bioengineering

1 Overview of Culture Medium Components To absorb nutrients, synthesize self-constituent substances and complete proliferation, cells require fundamental materials, including inorgan……

For antibodies produced in mammalian cell lines such as Chinese Hamster Ovary (CHO) cells, viral contamination constitutes a potential safety risk. Characterizing the viral clearance……

During the development, commercial production and clinical application of protein drugs, protein aggregation stands as one of the major challenges. Protein aggregation may occur thro……

Preface Currently, there is no clear regulatory guideline that defines high-concentration antibody products (HCAPs). In literature, formulations with a protein concentration above 10……

Continuous biomanufacturing processes have attracted extensive attention in the biopharmaceutical industry due to their outstanding advantages, including reduced facility footprint, ……

During the development, commercial production and clinical application of protein drugs, protein aggregation stands as one of the major challenges. Protein aggregation may occur thro……

Rabies is an acute infectious disease caused by the Rabies virus (RABV), commonly transmitted through bites or scratches from infected animals, mainly including dogs, cats, bats and ……

The in-use stability study simulates the actual clinical application scenarios of biological products and investigates critical quality attributes including physical, chemical and bi……

Preface With the rapid advancement of the biopharmaceutical industry, the demand for the development of high-concentration protein formulations (HCPF, >100 mg/ml) continues to gro……

Cell culture process scale-up is a critical step in the production of therapeutic proteins. To meet market demand for therapeutic proteins, production must be scaled up to commercial……

As a vital component of modern pharmaceutical industry, biological products play an essential role in disease treatment and public health protection. The biological product industry ……

Bispecific antibodies (bsAbs) represent a promising class of biotherapeutics. Accordingly, downstream processing of such antibodies is critical to ensuring the production of high-pur……

In the biopharmaceutical industry, Chinese Hamster Ovary (CHO) cells have emerged as the gold-standard expression system for recombinant protein production. The conventional fed-batc……

Since the first monoclonal antibody drug was approved in 1986, the research and development of antibody drugs have flourished. Up to now, antibody drugs have become an important part……

With the continuous advancement of biomedical technologies, multispecific antibodies (MSAs) have demonstrated enormous potential in the therapeutic field. Capable of targeting multip……

Virus-like Particles (VLPs) are unique biomaterials that structurally mimic the morphology and configuration of native viruses, yet they contain no viral genetic material such as DNA……