EAG’s biotechnology experts provide a wide range of studies necessary to complete weight of evidence allergenicity and hazard profiles for genetically engineered proteins and crops. Starting with Tier 1 for hazard classifications, our dedicated scientists can assist in navigating through the regulatory agency requirements and provide GLP-compliant data to support the risk assessments and allergenicity profiling. Using ELISA, HPLC, Western Blot, SDS PAGE, Mass Spec, and other analytical techniques, our scientists generate data for the allergenicity or hazards of a protein.
- Regulatory Requirements: EAG scientists have a long tradition of collaborating with a variety of regulatory agencies, both domestic and internationally. Our knowledge and experience is invaluable to clients struggling to include all of the requirements for safety and risk assessments.
- Protein Characterization: Tier 1 requires full protein characterization for all proteins expressed by the genes of interest. EAG scientists have the experience, instrumentation and methods to characterize these proteins using a variety of techniques. Size, amino acid sequence, isoelectric point, post-translational modification, and stability are all tests commonly performed by our experts.
- Digestibility Assays: Another part of the Tier 1 hazard assessment is that digestibility assays must be performed on all proteins. EAG scientists can perform both simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) assays. When regulations change and require incorporating multiple protein concentrations and pH levels or different ratios of protein to pepsin, we can design and perform the requested analyses.
- Expression Level and Dietary Intake: EAG scientists routinely develop methods to extract and quantitate protein levels from a variety of matrices including growing plant tissues and processed consumer products. Dietary intake and exposure can be tested providing a third aspect of the Tier 1 hazard assessment.
- Serum Screening: EAG scientists develop and validate methods for screening serum for potential allergenicity in vitro. Serum screening can include such things as IgE (immunoglobulin E) testing to identify whether the GM protein results in cross-reactivity with known allergens. Before initiating any in vivo studies, knowing the potential for allergic responses to a variety of serum types from several subjects allows our clients to design better studies reducing the potential for harm or complications in the in vivo
Our team of biotech experts brings over two decades of protein science experience to the allergenicity and hazard safety assessments of engineered crops, proteins, and crop by-products.