admin_liu，作者Sino Bioengineering I Biopharma Cleanroom and Process Equipment Manufacturer - 第3页 共9页

High-cell-density fermentation (HCDF) technology serves as the core pillar of modern biomanufacturing, playing an irreplaceable role in the efficient production of recombinant protei……

1. Introduction The downstream processing of biologic manufacturing is divided into three core stages: capture, purification, and polishing. Among these procedures, endotoxin removal……

In the R&D and manufacturing of nucleic acid drugs, supercoiled plasmid DNA (scDNA) serves as the core raw material for mRNA vaccines, DNA vaccines and gene therapy vectors, as w……

In 1957, Puck isolated the original Chinese Hamster Ovary (CHO) cell line. Since then, CHO cells have been widely utilized in the pharmaceutical industry for the producti……

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. ……

Gathering Industry Elites, Let’s Meet in Nanjing! Hosted jointly by the China Vaccine Industry Association, the Biologics Branch of Chinese Preventive Medicine Association, and the ……

Recently, Sino Bioengineering completed a high-standard and high-intensity Factory Acceptance Test (FAT). The client team from a well-known European pharmaceutical enterprise visited……

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……