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IN-house Laboratory Services

Process Contaminants

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.

The use of so called serum free defined media greatly reduces the number of potential contaminants but it may still be necessary to determine trace contamination levels of the proteins and growth factors used in these 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.

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Efforts to reduce trace media contamination to the lowest levels practical through optimal process design, validation, and final product testing require a sensitive and reliable analytical method.

  • 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 follow:

  • ELISA
  • 2D-Western blot

Protein A

Affinity chromatography on protein A-columns is widely used for the 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.