IN-HOUSE Laboratory Service

PROCESS CONTAMINANT ANALYSIS

The manufacture of products by various biotechnological processes such as cell or tissue culture can result in residual contamination of the desired product by components used in the culture media. When the intended product is used as a therapeutic agent in humans or animals, the product should be highly purified to avoid potential health risks or other problems that might result from trace contaminants.

We perform the following testing using qualified methods:

Host Cell DNA
Host Cell Protein
Protein A
BSA/HSA
Protease

Testing Methods

Host Cell DNA

The removal of host cell impurities is a critical step in the purification of biopharmaceutical products. A major challenge is the accurate and sensitive quantitation of host cell DNA impurities in both the purification process and in drug substance samples. Zelle Biotechnology Pvt. Ltd. Provides HCD testing using

ELISA
PCR

Host Cell Protein

Biopharmaceuticals require products to be free of host cell protein (HCP) contaminants. These HCPs may be left behind during the purification process from the expression hosts, such as E. coli, insect, or mammalian cells. Zelle Biotechnology Pvt. Ltd. Provides analytical testing to investigate the presence of residual contamination during the bioprocessing and the final biopharmaceutical product using techniques as follows:

ELISA
2D-Western blot

Protein A

Affinity chromatography on protein A-columns is widely used for purifying monoclonal and polyclonal antibodies. Protein A may sometimes leak from the column and contaminate the preparation. Immunoglobulin reacts with protein A in vivo and may cause anaphylactic reactions. Contamination with protein A may also cause false results in immunological assays. Thus it is important that the antibody preparation be free from protein A before being used. Analysis of this protein A is primarily done using ELISA.

BSA/HSA

The manufacture of products by various biotechnological processes such as cell or tissue culture can result in residual contamination of the desired product by components used in the culture media. When the intended product may be used as a therapeutic agent in humans or animals, the product should be highly purified to avoid potential health risks or other problems that might result from trace contaminants. This BSA/HSA ELISA assay is designed to provide a simple to use, precise, and highly sensitive method to detect BSA/HSA contamination.

Protease

During protein purification processes, especially for therapeutic proteins, even trace levels of contamination can impact the protein's stability and activity. A sensitive protease assay should be useful for applications in which contaminating proteases are detrimental and protein purity is essential.

IN-HOUSE Laboratory Service

Protein Characterization

Process Contaminant Analysis

Bioassays

Process Development