Our analytical department offers unique integrated analytical capabilities and expertise, delivering complete and high-quality packages of analytical services for drug discovery and each stage of the drug development, customized for each phase - from early definitions to analytical tech transfer, in a certified GMP environment, fully approved by FDA, MHRI and AIFA..

Evotec analytics benefits from a broad range of analytical technique expertise and capabilities for the development of phase relevant methods for active ingredients (API) and drug products.

Method Development, Validation & Technological Transfer

Analytical experts take a structured, straightforward and reliable approach for method transfer, development, optimization and validation based on Quality by Design (QbD) principles.

Evotec scientists are aided by the latest generation software tools, such as Waters Fusion Method Development™, Empower™, and Method Validation Manager (MVM) to support both development and validation and to deliver effective solutions for each pharmaceutical development phase.

Experts in Genotoxic and Nitrosamine impurities to support possible control strategies and also in the development and validation of bespoke analytical methodology as required.

FDS are performed for development purposes on drug substances and drug products to prove the stability indicating power of the assay/degradation products method and for confirmation of the potential compound degradation pathway.

• Specialized personnel with solid experience and cutting-edge facilities make Evotec an ideal, trustworthy partner for analytical and stability services 
• Fully electronic data management through proprietary LIMS and stability information system (CFR 21 Part 11 compliant) ensure an unequalled level of quality, traceability, security and control of your data and samples 
• Stability experts offer all key ICH and WHO storage conditions, tailored stability study design from formulation screening to market registration and regulatory submission support 
• Stability data intended for use in Investigational New Drug (IND) or Investigation Medicinal Product Dossier (IMPD) submissions, or where the data is intended to be used in a regulatory submission (NDA, MAA etc.) or in response to a stability related regulatory question or comment 

cGMP Walk-in stability chambers covering all the ICH (International Council for Harmonization) and WHO (World Health Organization) storage conditions (Zones IVa and IVb included).

Freezers and ovens at high temperature are also available to support stress testing studies, like thermal cycling and temperature excursion studies and light cabinet Photostability studies.

The ASAPprime® study is a very powerful and versatile tool, based on dedicated statistical analysis of data generated from samples exposed for short times (typically 21 days) to specific combinations of stress conditions, i.e., temperature and humidity - based on that and our dedicated experts, swift data interpretation and precise drug product shelf-life estimation are no longer challenges, but a seamless reality.

Better and faster prediction of your drug product’ stability is possible for any:

• Packaging configuration (material or fill count)
• Climatic zone
• Temperature or humidity excursion

ASAP study can be a valid alternative approach to the standard ICH-like study run on the demo batches during regulatory submission.

• Dedicated laboratories designed according to Lean Six Sigma principles for enhanced efficiency, minimizing analyst movement and reducing variability.
• Experts and dedicated team of scientists with significant experience in analytical inhalation.
• Delivered Dose Uniformity (DDU) and Aerodynamic Particles Size Distribution (APSD) characterization in controlled temperature and humidity environment complemented by antistatic devices to reduce variability.

• Best-in-class laboratories equipped with state-of-the-art technologies to support the characterization of the API, processed API (post Particle Engineering Study) and formulation development.
• Team of Scientists with an extensive expertise in solid state chemistry
• Our capabilities include Micromeritics (particle size, surface area, DVS, pycnometry, powder rheology, wettability), spectroscopy (FTIR, Raman, NMR), X-Ray Diffraction (XRPD, including non-ambient and 2D), SAXS, thermal analysis (DSC, TGA, TGA-IR), microscopy (PLM, ESEM+EDX)

Evotec provides GxP analytical capabilities to support APIs, oral DP forms (e.g. tablets, capsules, suspensions, spray drying material etc.) and dry powder inhaled products characterization by

• Assay, related substances content by HPLC-UPLC-LC/MS, CAD, Ion Chromatography, Fluorimeter, GC, HS/GC, GC/MS techniques
• High Resolution Mass Spectrometry (HRMS) capable of characterizing impurities at very low levels and an accurate quantification
• UV / IR spectroscopy
• NMR (400 MHz with broadband probe & 600 MHz with cryo-probe) and HRMS
• Enantiomeric purity by HPLC and polarimetry
• Water content by KF
• Dissolution (apparatus I, II, III, IV and IDR) and disintegration test
• Physical properties and solid state characterization by particle size distribution, SD, optical & electron microscopy, SSA, XRPD, Rheology-FT4, TGA, spectroscopy, DSC
• Aerodynamic particle size distribution by NGI
• Uniformity of delivered dose

Qualified spaces for the Sample Management: a robust GMP Laboratory Information Management System (LIMS) ensures comprehensive data recording, supported by an electronically controlled (QRcode) sample management system for precise management of standards, samples, and columns.

Some of Our Numbers

• Up to 10,000 samples managed per year with full sample traceability
• 90m3 in house stability chambers

Evotec is distinguished by a long track record of scientific expertise in the application of a wide range of analytical techniques and relies on three key significant strengths: 

• Web-based computer systems developed in-house using various technologies support the analytical workflow 

• A global, customized, fully validated GMP Laboratory Information Management System (LIMS) for data acquisition, recording, evaluation and reporting, tailored to pharmaceutical QC needs 
• Data integrity and the management of analytical data is guaranteed by Evotec Verona LIMS that is interfaced with the CDS (Chromatographic Data System) by a bespoke interface designed for the management of weighing process (including a direct weight capture from balances) and chromatographic sequence 
• A large suite of automated platforms to ensure high data quality, prompt test responses and productivity