Blog - SHENTEKBIO

21 2025.07

Ensuring Safety Through Precise Residual Host Cell RNA Quantification

During upstream and downstream processing, genetic materials - particularly RNA - from production host cells (e.g., E. coli, HEK293) may persist in the final drug substance. These impurities, even at ...

21 2025.07

Ensuring Safety Through Precise Residual Host Cell RNA Quantification

During upstream and downstream processing, genetic materials - particularly RNA - from production host cells (e.g., E. coli, HEK293) may persist in the final drug substance. These impurities, even at ...

22 2025.04

Host Cell Protein HCP ELISA Analysis Method Introduction

Introduction to HCP ELISADuring the production of biopharmaceuticals, especially monoclonal antibodies, vaccines, and other recombinant proteins, the detection of host cell protein (HCP) residues is a...

15 2025.04

Main Methods of RCR Testing

What is RCR Testing?RCR testing refers to a series of methods used during the preparation of CAR-T cell therapy products to detect the presence of Replication Competent Retrovirus (RCR) or Replication...

08 2025.04

The Importance and Methods of Residual Host Cell Protein Analysis

Definition and Impact of Host Cell Protein ResidualsHost Cell Protein (HCP) residuals refer to protein components derived from the production host cell line present in biopharmaceutical products. Thes...

01 2025.04

An Introduction to Assay Methods for Residual Host Cell DNA in Biological Products

Host cells are the cornerstone of biological products, and mammalian cell lines have now become the most widely used hosts for the expression and preparation of biological products. Common host cells ...

08 2024.05

The Future of QC Labs: Digitization, Automation, and Online Testing

Emerging technologies such as advanced analytics, robotics, and automation promise significant rewards for the pharmaceutical industry, including increased speed, compliance, cost savings, and product...

26 2024.04

Residual Host-Cell DNA Risk Assessment

Biologics are expressed from the hosts of bacterial, yeast, animal cells, and continuous cell lines. As biological products are produced from a cell substrate, it is inevitable that residual host cel...

16 2024.04

The Need and Approach of Host Cell Residual RNA Detection

Plasmid DNA (pDNA) are applied for gene therapy and vaccine development. The purification of DNA plasmids is difficult, because supercoiled pDNA (the product) is quite similar in size and structure to...

21 2024.03

Detection of Adventitious Agents in Biological Products

Adventitious agent contaminants in seed stocks, cell substrates, and raw materials used in the production of biological products include bacteria, fungi, mycoplasma, mycobacteria, and viruses. Effecti...

28 2024.02

Residual Host Cell Protein Identification and Quantitation

Recombinant proteins are primarily expressed in host cells, such as bacteria, yeast, mammalian, insect, or plant cell lines. During the bioproduction process, these host cells also produce by-product ...