Creative Biolabs upgrades its therapeutic antibody and protein development platform, with enhanced capabilities in endotoxin removal and detection.
SHIRLEY, NY, UNITED STATES, May 15, 2025 /
EINPresswire.com/ -- As
antibody- and protein-based drug development technologies continue to mature, quality control of biologics is receiving attention. According to Creative Biolabs, the update covers the entire workflow, which includes gene design and functional validation, with particular focus on endotoxin risk management.
Endotoxins, a common contaminant in biologic materials, can compromise drug stability and purity and potentially trigger unpredictable immune responses in cell-based and animal studies. In severe cases, they may even undermine the credibility of preclinical data.
"Endotoxin control is a frequently underestimated yet critical step in the drug development process," said an expert at Creative Biolabs. "We've seen across numerous projects that even trace amounts of endotoxins can interfere with cellular responses and alter the immunological profiles of antibody candidates. This has led us to reinforce detection mechanisms from the source and diversify removal strategies for different sample types."
Creative Biolabs currently offers a broad portfolio of
endotoxin removal services. This service reduces endotoxin levels using numerous techniques such as membrane adsorption, affinity chromatography, ion exchange, and ultrafiltration. For applications with stringent protein structure requirements, the company has also introduced the EXLow™ detergent-free chromatography approach. Internal data show that the service can reduce endotoxin levels to below 0.5 EU/µg across various antibody- and protein-based products.
For endotoxin detection, the platform integrates both conventional
Limulus Amebocyte Lysate (LAL) assays and emerging biosensor technologies. The LAL method, still the industry standard, is available in three formats: gel clot, turbidimetric, and chromogenic assays—supporting everything from qualitative screening to high-throughput quantification. Additionally, biosensors based on electrochemical, optical, and mass spectrometry principles are being adopted for complex samples or applications requiring higher sensitivity.
The update highlights enhanced customization and traceability. Workflows for detection and removal are easily adjustable to align with the biologics development stage, including prokaryotic and eukaryotic expression systems, fusion proteins, and antibody fragments.
"We intend to construct a modular platform with high adaptability that not only supports early-stage research but also has the capability to shift toward industrial application," remarked the expert.
While endotoxin control is only one part of the antibody development workflow, its importance in enhancing process reliability and data integrity is gaining broader recognition. With this platform update, Creative Biolabs seeks to establish a more structured approach to quality assurance, helping pave the way for the next generation of antibody and protein therapeutics.
To learn more about Creative Biolabs' therapeutic antibody and protein development services, please visit
https://www.creative-biolabs.com/immuno-oncology/.
About Creative Biolabs
Creative Biolabs is a CRO specializing in biopharmaceutical R&D services. It is dedicated to offering innovative solutions in therapeutic antibody engineering, protein design, vaccines, and cell and gene therapies. Comprehensive services in monoclonal antibody discovery, optimization, expression and purification, and functional assays both in vitro and in vivo are offered by Creative Biolabs.
Candy Swift
Creative Biolabs
+1 631-830-6441
marketing@creative-biolabs.com