Bringing a biologic to market is a marathon. At Elion, we welcome the challenge, and we want to partner with you to address your analytical characterization needs along the way. We work closely with our clients to develop lasting solutions to analytical challenges faced during development of biologics. We want to make contract analytical work simple, at reasonable cost. Our ultimate goal is to help you bring life changing therapies to patients.
Elion was founded to serve the analytical development and product characterization needs of the biopharmaceutical industry. We offer a variety of services, including:
We are committed to providing these services with unmatched quality.
On average, members of the Elion team have over 15 years of direct experience in the biopharmaceutical industry, largely focused on bringing clinical products to market as well as lifecycle management of commercial protein products. We have directly supported world-wide regulatory applications for registration of multiple biologics by authoring and reviewing CMC components of those applications, including elucidation of structure, drug substance and drug product impurities, reference standard qualification, specifications, stability, comparability, biosimilarity and integrated control strategy sections.
Furthermore, our team has extensive experience with product characterization requirements, including meeting regulatory expectations for biochemical, biophysical, particle, and degradation pathway characterization. Our team has supported over 100 comparability studies, 30 stability studies, and 20 reference standard qualifications. We have developed and implemented universal characterization methods, qualification approaches, and acceptance criteria, leading to significantly increased efficiency in the application of analytical methods.
We have a proven track record in gaining regulatory approval in multiple jurisdictions for reductions in Quality Control analytical testing by creating science-based justifications to eliminate redundant or non-value added tests and focusing testing on the most relevant product quality attributes. We have developed rapid analytical test methods, improved data analysis methods, and statistical biosimilarity strategy for demonstrating overall similarity of biosimilar products to innovator products. At Elion, we are committed to using appropriate technologies, sophisticated data analysis, and our prior experience to provide significant value to our clients.
Fourier Transform Infrared (FTIR) spectroscopy provides analysis of protein secondary structure. Elion uses quantitative spectral comparisons and the the Bruker Optics Vertex70 spectrometer capable of analyzing up to 15 samples per day. Time estimates are for orders of up to 45 samples.
Elion provides a wide range of HPLC separation services including size exclusion, ion exchange and reversed phase chromatography.
Multi-angle light scattering (MALS) used in conjunction with a liquid chromatography method, such as size exclusion chromatography, provides absolute characterization of the molar mass of individual peaks eluting in the LC profile. Elion uses the Wyatt TREOS MALS detector. Time estimates are for orders of up to 30 samples.
Differential scanning calorimetry (DSC) can be used to evaluate protein thermal and conformational stability. Elion uses the MicroCal VP-Capillary DSC capable of analyzing up to 10 samples per day. Time estimates are for orders of up to 30 samples.
Microflow imaging (MFI) is a subvisible particle analysis method providing information on particle size, morphology, overall particle concentration, and subpopulation concentrations and characteristics. Elion uses a ProteinSimple MFI system capable of analyzing up to 10 samples per day. Time estimates are for orders of up to 30 samples.
Circular Dichroism (CD) spectroscopy provides protein structural conformation evaluation. Analysis in the far UV allows for detection of changes in protein secondary structure. Analysis in the near UV allows for detection of changes in protein tertiary structure. Elion uses quantitative spectral comparisons and the Applied Photophysics Chirascan™-plus CD spectrometer capable of analyzing up to 15 samples per day. Time estimates are for orders of up to 45 samples.
Sedimentation velocity analytical ultracentrifugation (SV-AUC) analysis has become the standard orthogonal method to size exclusion chromatography for the determination of sample aggregation profile. SV-AUC allows for sample analysis directly in formulation enabling direct measurement of the soluble aggregate content. Time estimates are for orders of up to 21 samples.
Our SV-AUC experience includes over 10 publications, extensive analysis of over 20 products, and an average of 9 years of experience running and developing AUC methods. Contact Elion with inquiries or if you have a non-standard request (e.g. sedimentation equilibrium, variable f/f0, viral particle analysis, etc.)
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