Ellipse Pharmaceuticals provides state-of-the-art analytical services for New Chemical entities including development and validation of methods and stability studies according to ICH guidelines.

Ellipse Pharmaceuticals and SPI-BIO, together with the Life Sciences Department of the CEA (French Atomic Energy Commission) also offer a wide range of methods to assess the physico-chemical properties of therapeutic peptides and proteins from the active ingredient to the finished product.


A full range of services

Whatever your need is, from stand alone services to full development program, Ellipse Pharmaceuticals provides tailored-made solutions including:

Analytical Development & Validation

*Transfer and optimisation of analytical methods * Method development and adaptation throughout the formulation development * Validation, carried out following international standards and guidelines (ICH)

Quality control (EP, USP or Internal monograph

A well equipped laboratory

* High Pressure Liquid chromatographic systems (10 units) * A wide range of detectors (UV ; UV / diode array, refractometer) * Gas Chromatography system * Dissolution tests (UV in-line, HPLC) (Listing of apparatus available on request)

Specific Analytical Studies

* Compatibility studies (DSC and HPLC) * Laser Granulometry studies * Polymorphism studies (X Ray diffraction, DSC) * Photostability * Interaction formula/ primary packaging

Stability Studies

* Studies conducted according to ICH guidelines * Storage on site (24H monitoring and alert system) * 05°C ± 3°C * 25°C ± 2°C / 60%RH ± 5% * 30°C ± 2°C / 65%RH ± 5% * 40°C ± 2°C / 75%RH ± 5% * Full analysis at each timpe-points

		We offer a comprehensive expertise based on customised analytic programs in order to develop and validate specific methods and to resolve key issues along the drug development process * API Development * Finished Product Development * Batch Release (QC Controls) A full range of services * Purity and titer * Size and charge * Primary, secondary and tertiary structure * Aggregates, oligomers, non-covalent complex * Impurities * Glycosilation sites, pattern/sequencing * Biological activities and binding * Immunogenicity A permanent focus towards quality of services The documentation & Human means - An active participation and responsibility of firm management - 1 QA Manager and 1 QA delegate - A participative and committed staff with training QA program The control of effectiveness - 100% Data checking - OOS - OOT results investigations - Complete study audits (according contractual demand) - Self- inspection and audit program - Follow–up of corrective action plans The regulatory compliance - A GMP based QA system for stability and quality control activities - A GLP based organisation for development studies - An official recognition by the french authorities in progress - A QA system concerned with cGMP and FDA requirements A good knowledge of regulatory requirements A high level and experienced team Back