Insight I Sino bioengineering

1. Importance of Chromatography Resin Validation Chromatographic processes have become an indispensable unit operation in biopharmaceutical manufacturing, and chromatography resins t……

1. Expansion of Process Characterization Study Conventional process characterization approaches and studies enable the accumulation of product and process understanding. However, it ……

Cleaning validation plays a critical role in mitigating cross-contamination risks for manufacturing equipment in the biopharmaceutical industry. It demonstrates that the defined clea……

The pharmacological functions of bispecific antibodies (BsAbs) can be broadly categorized into three core mechanisms: Cell-engagers, Non-cell bridging, and Receptor-ligand blockade. ……

Over the past two decades, biopharmaceuticals have achieved groundbreaking advances in improving the quality of life of patients with various cancers, autoimmune diseases, genetic di……

In recent years, with the emerging challenges of tumor heterogeneity, immune escape mechanisms and the complexity of the tumor microenvironment, regulation relying solely on two targ……

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……