Dr. Thomas Kofoed
CEO, Alphalyse
Project Goal
To address biopharmaceutical industry needs by developing fast, accurate, standardized methods for qualitative and quantitative Host Cell Protein (HCP) analyses, to help lead to safer biotherapeutic drugs.
The Challenges
- Detecting HCP contaminants that could adversely affect the drug product or provoke immunogenicity in a patient.
- Achieving reproducible detection of extremely low levels of HCPs present with high concentration of biologic product.
- Ensuring confident HCP detection, without sacrificing sample throughput.
The Solution
- An LC-MS solution with high-performance sensitivity & linear dynamic range, with comprehensive data independent acquisition, and software to interpret the data.
The Outcomes
- Since the TripleTOF 6600 MS can detect even ppm quantities of HCPs, adverse effects of a drug product or provoking immunogenicity can be avoided.
- Unbiased SWATH Acquisition collects data for all detectable species to enable identification and quantification of each HCP reliably in drug batches.
- Utilizing this technology Alphalyse can provide an HCP service that customers can trust.
Type of Organization
Contract research organization (CRO), specializing in protein chemistry, mass spectrometry, and bioinformatics.
Goals
To reliably identity and quantify each host cell protein (HCPs) in batches in a timely, cost effective manner for safer pharmaceuticals.
Applications
SWATH® Acquisition: Data Independent (DIA) Scanning for Host Cell Protein Detection
SCIEX products
- TripleTOF® 6600 System
- SWATH® Acquisition
- ProteinPilot™ Software
- PeakView™ Software
- BioPharmaView™ Software