Athens Bioscience, Inc., a manufacturer of native human and animal proteins for the global life sciences industry, today announced the introduction of new analytical quality standards for its protein Certificates of Analysis (CoAs). Effective immediately, every new production lot ships with lot-specific, quantitative purity data—replacing the subjective visual assessments and generic representative images that have long been the industry norm.
Protein purity is a foundational quality attribute for manufacturers of in vitro diagnostic kits, cell culture media, calibrators and controls, and immunological reagents. Yet across much of the industry, the Certificate of Analysis that accompanies a protein product has remained largely unchanged for decades: a purity claim estimated by visual inspection of an SDS-PAGE gel, often illustrated with a representative image that may not correspond to the customer’s specific lot.
“We looked at what our customers actually need from a CoA and realized there was a significant gap between what the industry provides and what quality-driven manufacturers require,” said Karson Durie, Lab Director at Athens Bioscience. “When an IVD manufacturer is qualifying a raw material or a researcher is validating an assay, they need measured values tied to their specific lot—not a visual estimate from a different production run. That’s the standard we’ve built our new CoA program around.”
Quantitative Densitometry on Every Lot
Under the new standard, every Athens Bioscience production lot undergoes SDS-PAGE with quantitative densitometry. Rather than relying on a subjective assessment of gel band intensity, the company generates a densitometry trace that measures the relative intensity of every band on the gel. The resulting purity value—expressed as percent major band—appears directly on the CoA alongside the actual gel image from the customer’s specific lot.
For IVD manufacturers performing incoming quality control, this means the documentation needed to support vendor qualification is already in hand. For researchers, it provides an objective basis to evaluate the protein before opening the vial. For procurement teams, it eliminates a round of redundant internal testing during supplier approval.
Mass Spectrometry–Verified Composition for Immunogen-Grade Products
Athens Bioscience has also introduced full compositional analysis by LC-MS/MS for its immunogen-grade product line. Performed on a high-resolution Orbitrap platform, this analysis identifies every detectable protein in a sample by searching against the UniProt human proteome database, then reports the relative abundance of each component.
The result is a clear compositional profile: target protein identity and abundance, subclass distribution where applicable, and any trace co-purified proteins—identified by name and quantified by relative signal intensity.
“SDS-PAGE is an essential quality tool, but it has well-known limitations,” Durie added. “Two proteins of similar molecular weight will co-migrate on a gel and appear as a single band. Mass spectrometry resolves what gels alone cannot. For customers who are immunizing animals, developing calibrators, or building an assay around a known standard, that level of compositional clarity is the difference between confidence and assumption.”
“This initiative reflects what Athens Bioscience has always stood for—giving our customers the information they need to make sound scientific and manufacturing decisions,” said John Mitchell, Chief Executive Officer of Athens Bioscience. “We believe a Certificate of Analysis should be a quality document you can actually use, not a formality you file away. The response from our customers has confirmed that this is a standard the industry has been waiting for.”
The raw analytical data behind every CoA is available to customers on request, enabling independent review by internal quality teams. The new CoA standards apply to all new production lots across the Athens Bioscience catalog, with immunogen-grade compositional analysis available for the company’s high-purity product line.
About Athens Bioscience
Athens Bioscience, Inc. (formerly Athens Research & Technology, Inc.) manufactures native human and animal proteins for the global life sciences industry. Founded in 1986 and headquartered in Athens, Georgia, the company serves IVD manufacturers, cell culture media companies, pharmaceutical researchers, and academic institutions worldwide. For more information, visit www.athensbioscience.com.