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Comprehensive solutions for method development, method knowledge, and method transfer coving the lifetime of your drug product monitoring

What is Method Lifecycle Management?

Method Lifecycle Management (MLCM) is a control strategy ensuring that as long-term methods evolve, they perform as originally intended throughout their lifetime.

Changes in production materials, analytical instrumentation, consumables, or modifications to the drug product can have an impact of a validated method to continue to meet their original criteria.

Challenges also extend to inter-laboratory method transfer either internally or to outsourcing partners such as contract research organizations (CROs). It is critical that from development and analytical method validation, through to method transfer and long-term performance monitoring that continuous knowledge of the method is captured and used to asses the impact of any changes in the future such as a change in manufacturing process or a change in the analytical column used for separation.


Important stages of Method Lifecycle Management

Important stages of Method Lifecycle Management

Analytical Target Profile (ATP)

ATP underpins all stages and states the requirements of the analytical procedure at all stages, such as accuracy and precision. The ATP is driven by the known CQAs of the product.

Method qualification

Method qualification requires robust technology and software to give confidence the developed method will perform as expected over an extended period.

Method design and development

Method design and development requires an upfront knowledge of the product's critical quality attributes (CQAs), often by the implementation of Analytical Quality by Design (AQbD). Instruments are required to have flexibility in use to facilitate parameter adjustments, and automated features built in to both speed up, and ease the burden of screening method parameters and consumables.

Method verification

Method verification requires long term monitoring of the method, including when changes happen such as method transfer or a change in production. Implementing new technology typically allows for more improved methods, but the impact on legacy methods must be minimal and monitoring of CQAs is not compromised.

Thermo Fisher Scientific Analytical Technologies for the Pharmaceutical Industry - Anthem Video

At Thermo Fisher Scientific, our pharmaceutical analytical technologies ensure you get accurate results, day after day, run after run.

We deliver confidence in production control and lot release testing to ensure that drugs are safe and of a consistently high quality.

Our software and chromatography capabilities, built for regulated environments, provide operational simplicity, verifiable performance, and quality by design.

Method development

UltiMate 3000 and Vanquish Core HPLC instruments for the compendial analysis of commonly prescribed drugs

This application note is intended to demonstrate the usability of Vanquish Core and UltiMate 3000 HPLC instruments for the straightforward application of compendial methods.

 Download application note ›

ICH guideline update: Method lifecycle

The International Council for Harmonisation (ICH) has updated its guidelines Q2 and added Q14 to cover method lifecycle from development to validation with the emphasis for analytical scientists to focus on incorporating a quality mindset through method lifecycle.

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Technology to simplify method transfer

Thermo Scientific Vanquish Core HPLC System enables easiest method transfer

Confidently transfer methods from other labs or even other equipment seamlessly with the use integrated tools and software. Our method transfer tools allow you to duplicate other HPLC vendors’ system settings to more easily replicate methods, such as those from a  Waters Alliance HPLC system,  Agilent 1260 Infinity LC system and  Shimadzu Nexera-i system to a Vanquish Core HPLC system.

Method validation and secure data storage

Automate design and execution of robustness testing using ChromSword AutoRobust Chromeleon Connect and accelerate your method validation using the workflows available in the Chromeleon 7 Extension Pack ICH templates. The Chromeleon Data Vault ensures secure data storage and accessibility for users within the CDS infrastructure. With Vanquish Method Development HPLC and UHPLC systems, all data generated is safely backed up in Chromeleon CDS Data Vault, enabling easy data exchange throughout the organization.

 

Enhance your capabilities with the pharmaceutical applications compendium

 Download compendium ›

Industry stories and solutions

HPLC systems

Advanced LC systems for solving tough analytical challenges

Obtain new benchmarks in accuracy, precision, and sensitivity with the Thermo Scientific Vanquish HPLC and UHPLC systems. With state-of-the-art quaternary or binary high-pressure solvent blending, these ultra-high-performance liquid chromatography systems share all Vanquish values, such as a design focused on uptime, robustness, and reliability. Built-in tools for seamless method transfer and long-term performance to ensure you have the confidence to run any assay without compromise.

Vanquish Flex UHPLC Systems

Succeed with flexibility. Vanquish Flex UHPLC systems excel from method development to routine analyses. With binary and quaternary pump options, the Vanquish Flex UHPLC systems offer outstanding performance for LC and LC-MS based nitrosamine workflows.

Vanquish Core HPLC System

Eliminate disruptions to your routine analytical work with the Vanquish Core HPLC system. Switching to Vanquish Core is simple and seamless. A full suite of method transfer tools, including tune-able gradient delay volume, makes adoption easy. Like all members of our Vanquish product line, Vanquish Core HPLC systems offer hardware precision and simplicity of operation. Ideal for routine nitrosamine impurity analysis.

  • Separate more peaks than ever before. The Vanquish system improves specifications on all fronts. It supports higher backpressures, better thermostatting, optimized volumes, better linearity, and more sensitivity.
  • Regain time during your projects. The system improves analysis speed, increases sample capacity and has improved robustness.
  • Operational simplicity of the Vanquish system provided by optimized design and automated features.

Select the best system for your laboratory ›

Single Quadrupole MS

Add mass spectrometry (MS) to your IC and LC analyses for access to the valuable data that only MS can provide

The easy-to-use Thermo Scientific ISQ EC Single Quadrupole Mass Spectrometer seamlessly integrates with ion chromatography (IC) and high performance liquid chromatography (HPLC) systems. Both novices and experts alike can quickly master MS to gain more insights from every sample.

ISQ™ EC Single Quadrupole Mass Spectrometer

ISQ EC Single Quadrupole Mass Spectrometer

Gain more insights

  • Higher sensitivity and more accurate quantitation
  • Chromatographic peak mass confirmation, eliminating false negatives and false positives

Resolve complexity

  • Improved resolution of analytes in complex matrices
  • Better selectivity
  • Resolve co-eluting peaks using their mass-to-charge ratio

Explore how mass spectrometry provides reliable verification and quantification ›

Charged aerosol detection (CAD)

Explore near-universal response along with the best performance, reliability, and flexibility in HPLC and UHPLC detection

Thermo Scientific Vanquish Diode Array Detectors (DAD) and Multiple Wavelength Detectors (MWD) detectors offer excellent linearity and optimized noise performance, and feature an ultra-wide dynamic range to allow detection of highly concentrated main compounds alongside trace-level impurities.

In addition, the Vanquish DAD HL uses Thermo Scientific LightPipe technology to achieve the best signal-to-noise performance through a combination of low baseline noise, a very long light path, and minimal dispersion.

 

Thermo Scientific Vanquish Diode Array Detectors (DAD) and Multiple Wavelength Detectors (MWD)

Thermo Scientific Vanquish Diode Array Detectors (DAD) and Multiple Wavelength Detectors (MWD)

  • Industry leading linearity with up to 2.7 AU
  • Reduced interfering refractive index and thermal effects means less baseline drift and more reliable peak integration
  • Data acquisition at rates of up to 250 Hz using up to 10 absorption channels and one spectral field delivers the best support of ultrafast separations
  • Intuitive user interaction, convenient flow cell and lamp usage tracking, and integrated wavelength validation through a holmium oxide filter contribute to ease-of-use

Unlike mass spectrometry, which requires an analyte to form gas phase ions, and UV detection, which depends upon the nature of the analyte’s chromophore, charged aerosol detection is a near universal detector.

The different selectivity between the three methods can be observed in the chromatograms on the left, which were generated using all three detection techniques simultaneously with a single injection. The results of charged aerosol detection are at the top, mass spectrometry results are in the middle, and UV detection results are at the bottom

Explore the benefits of CAD coupled with an HPLC or UHPLC system ›

HPLC columns and consumables

Quality columns you can rely on for quality results

 

Thermo Scientific HPLC and UHPLC colums are rooted in over 40 years of leading LC column technology to help you achieve the most accurate and reliable results from your HPLC analyses. Our extensive family of products offers a variety of particle sizes and column designs to meet all separation needs, including improved resolution, enhanced sensitivity, faster analysis, and consistent performance.

Because experiments, analytes, and budgets are different, we have organized our portfolio of SureSTART autosampler vials and closures into three performance levels to provide you with the affordability, compatibility, and performance you need.

Learn more about our column portfolio ›

HPLC column selection guide ›

SureSTART vial and well plate selection guide ›

HPLC Method Transfer-A CDMO perspective

Two Analytical Development Lab Chemists will share key learnings, feedback and best practices for transferring methods from competitive instruments and developing new ones onto the Vanquish liquid chromatography platform.

Lessons Learned from Transitioning to New Chromatography Instrumentation and Vendors

Lessons learned from the transition of a new fleet of chromatography equipment into an existing, up and running CDS.

The Successful Leap of Faith for an Established Chromatography Lab

Changing existing LC equipment in a regulated lab to a entirely new provider involves method transfer and solving challenges.

Panel Discussion: Making Instrument Equivalency Assessments and Actions Successful

Panel discussion on instrument equivalency and method transfer in CDMO environment when changing to a new instrument vendor.

Phase Appropriate Analytical Equipment and Method Lifecycle Management: Expert roundtable discussion

Experts from Pharmaron UK introduce analytical method life cycle approaches and provide two case studies on the topic.

The importance of impurity analysis at different stages of the pharmaceutical development and production process - Expert Roundtable

We chat to Novartis experts Julian Patoor and Adrian Clarke about the importance of impurity analysis.

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