Analytical development and Quality control

 

The analytical department offers unique integrated analytical capabilities and expertise, delivering complete and high-quality packages of analytical services for drug discovery and development, customised for each phase - from early definitions to analytical tech transfer, in a fully validated GMP environment.

Specific study types, services and technologies

Evotec analytics benefits from a broad range of analytical technique expertise and capabilities to provide for any development phase and API process development:

Method development, validation and technological transfer 

Analytical experts take a structured, straightforward and reliable approach for method development and validation based on Quality by Design (QbD) principles.
Evotec scientists are aided by the latest generation software tools, such as DryLab®, Empower™ and Method Validation Manager (MVM) to support both development and validation and to deliver effective solutions for each pharmaceutical development phase

Forced degradation studies (FDS)

FDS studies performed for development purposes on drug substances and drug products to prove the stability indicating power of the assay/degradation products method.

Stability studies
  • Specialised 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
  • All of the above studies are managed within the analytical and material sciences department
Stability facilities
  • All ICH-like stability studies on active pharmaceutical ingredients and drug products (oral form and inhalation DPI products) for climatic Zones I-II and World Wide registration (Zones IVa and b included), are guaranteed by the following climatic conditions: 
    • 5˚C/Amb.H 
    • 25˚C/60% RH
    • 30˚C/65% RH
    • 30˚C/75% RH
    • 40˚C/75% RH
    • 50˚C/Amb.H 
    • 50˚C/75% RH 
    • -20˚C/Amb.H
    • Photo-stability chamber
  • All of the above conditions are continuously kept in the acceptance limits of the ICH Guidance
Accelerated stability assessment programme studies (ASAP studies)

The ASAP study approach is a very powerful and versatile accelerated stability study tool, targeted at predicting and understanding API & DP stability on a short-term basis and the results evaluated by statistical assessment.

Inhalation analytical laboratories
  • Fully equipped inhalation lab for mono-dose and multi-dose DPI testing
  • Drug product characterisation studies & in vitro equivalence. Significant experience in reverse engineering of multiple innovators DPI products. Device verification testing and design verification testing
  • Next generation impactor (NGI) used to test in vitro lung dose (<5 µm, aerodynamic particle size distribution) in controlled temperature and humidity
Evotec GxP analytical capabilities for 

APIs, Oral DP forms (e.g. tablets, capsules, suspensions, spray drying material etc.) and dry powder inhaled products are supported by

  • Assay, related substances content by HPLC-UPLC-LC/MS, CAD, Ion Chromatography, Fluorimeter, GC, GCHS, GCMS techniques
  • 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 characterisation 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

Compliance and informatics systems

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 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

Contact us

Evotec

Business Development

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