Method Development, Validation, and Transfer

GMP-certified analytical method development and validation for small molecules, TIDES, biologics, and CGTs for CMC purposes.

Kymos has three GMP-certified, EMA and FDA-inspected EU sites fully dedicated to analytical method development and validation for CMC purposes of small molecules, TIDES, biologics, and Cell and Gene Therapies.

We use comprehensive and fit-for-purpose analytical procedures for the transfer, validation, or even development from scratch of pre-qualified, pharmacopoeia compendial and in-house methods in line with our client’s requirements and according to ICH, EMA, and FDA guidelines.

Our development and validation team is extremely proficient through exposure to a wealth of different APIs, excipients, preservatives, intermediates, and finished pharmaceutical products from pharma innovators with novel compounds or manufacturers of commercialized drug products.

Depending on your project requirements, we offer both conventional and AQbD-based analytical method development, with an approach tailored to the intended use and lifecycle of each method.

Our Analytical Solutions:

Kymos Group’s development and validation services often act as the entry gate for projects involving the following disciplines:

  • Identification
  • Assay Testing

  • Biological Potency

  • Related Substances (process and product related)

  • Residual Solvents

  • Elemental Impurities

  • Nitrosamine Impurities

  • Genotoxic Impurities

  • Dissolution Tests

  • Particle Size Distribution

  • Stability Indicating Methods

  • Extractables and Leachables

  • Orally and Nasally Inhaled Drug Products (OINDPs)

  • Cleaning and Process Validation

  • Other Assays with Specific CMC Departments

Our Technology and Platforms:

Kymos Group GMP-certified development and validation teams are fitted with dedicated instrumentation for the development of robust analytical procedures in the most challenging projects:

  • UV/visible spectroscopy

  • IR, FTIR

  • HPLC and UHPLC with different detectors: variable wavelength (VWD), diode array (DAD), refraction index (RI), evaporative light scattering (ELSD), corona discharge (CAD), amperometric and fluorometric

  • LC/MS: single QAD, Triple Quad and QTrap

  • GC: Flame ionization detector (FID), electron capture detector (ECD), with direct injection and headspace analysis

  • GC/MS

  • Atomic absorption spectrophotometry (flame with graphite furnace and hydride generator system)

  • ICP/MS

  • Karl Fisher volumetric and colorimetric (with oven sample processor)

  • Dissolution testing (with USP Dissolution apparatus 1, 2 and 4 and enhanced cells)

  • Cascade Impactor and Next Generation Impactor (NGI) for OINDPs

  • In Vitro Release Test for semi-solids with vertical diffusion cells

  • Electrophoresis, isoelectrofocusing, and Western Blot

  • Multitechnique ELISA readers

  • Universal testing machines for injection devices

  • Flow Cytometry

ALIGNED WITH ICH Q14

Our AQbD Approach:

We offer AQbD-based analytical method development aligned with ICH Q14, helping pharmaceutical and biotech companies build robust methods and manage their lifecycle more efficiently.

  • Improved robustness and reduced costs through a better understanding of method variability, helping avoid repeat work, unnecessary investigations and delays.

  • Easier method transfer and lifecycle management, supported by documented development knowledge and scientifically justified operating conditions.

  • A tailored development strategy, with conventional and AQbD-based options to suit each project’s needs and long-term goals.

Team Discussion

Why Choose KYMOS?

  • Regulatory Excellence:

    • We are FDA and EMA-inspected, GMP-certified, and our analytical procedures are processed according to the ICH Q2(R1), in line with Q6A and Q6B and FDA guidelines.
    • Our method transfers are compliant with EU-GMP chapter 6, performing interlaboratory reproducibility tests within a co-validation between two sites or a re-validation.

  • Global Trust:

    • We are trusted by manufacturers and pharmaceutical innovators worldwide due to our extensive experience with a wide range of methods.

  • Extensive Expertise:

    • Our teams have decades of experience and are highly proficient in developing methods from scratch, validating them, and preparing them for transfer.

  • State-of-the-art equipment and techniques

    • All our development departments are equipped with the latest instrumentation and capacity for developing and validating robust analytical methods as listed above.

Services

Related services to Method Development, Validation, and Transfer

Bioequivalence studies

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Sample preparation MS

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Analytisches CRO HPLCs

Batch Testing and Batch Release

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

 
 

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