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Cygnus Technology is a Pioneer and Leader for generic host cell protein ELISA kits & AAE (Antibody Affinity Extraction).
EXPERTISE
- Multi-method analysis of host cell proteins & biopharmaceutical impurities
- ELISA kits: Highly sensitive for the measurement of Host Cell Proteins and bioprocess contaminants
- Host Cell DNA amplification & extraction Kits
- Custom development of antibodies & assays
- Process-specific host cell protein development services including: 2D PAGE, 2D HPLC, AAE (Antibody Affinity Extraction) & MassSpectrometry
HCP Testing is an essential part of the biologics production process, and is widely used to save time and cost during analytical safety testing.
Host cell protein (HCP) testing is required during both process development and commercial manufacturing for protein-based biologics, and most vaccines and gene therapies.
Regulations require HCPs be reduced to the lowest levels possible. Cygnus’ generic ELISA kits are useful in both process development and process validation. Using these kits in the earliest phase of product development can provide relevant and specific data directing process improvement and decreasing the levels of HCP contamination.
- Reduce analytical methods development costs and time
- Accelerate R&D & purification process development
- Improve drug safety and efficacy
- Facilitate compliance with regulatory agencies
Products
DBA-ITALIA Srl
Via Umbria 10
20090 Segrate (Milano)
Tel. +39 02-26922300
Fax +39 02-26926058
Fax +39 02-26923535