Application
Analytical Development and QC
In pharmaceutical drug development, analytical development and quality control (QC) are critical functions that ensure drug substances (active ingredients) and drug products (finished formulations) meet safety, efficacy, and regulatory standards.
Analytical development establishes robust methods to characterize drugs at every stage, and QC applies these validated methods to verify quality and compliance before products reach patients.
Analytical Techniques in Analytical Development and QC
Some of the most common analytical techniques in Analytical Development and QC include:
- Chromatography (HPLC, UPLC, GC) – for purity, potency, and impurity profiling.
- Mass Spectrometry (MS) – for structural elucidation and impurity identification.
- Spectroscopy (UV-Vis, FTIR, NMR) – for molecular characterization.
- Dissolution Testing – to assess drug release from formulations.
- Elemental Analysis (ICP-MS, ICP-OES) – to detect trace metals in drug substances and drug products.
- Biological Assays (cytotoxicity, ELISA, endotoxin testing) – to measure the biological activity, potency, or immunogenicity
How Hamilton Supports your Analytical Development and QC Process Workflow
Hamilton offers robotic solutions that can automate (fully or partially) many of the analytical techniques used during analytical development and QC. In addition to liquid transfers, Hamilton liquid handlers can perform a wide range of tasks, including heating, shaking, cooling, (de)capping, pumping media to the deck, centrifuging, pH measurement, filtration, solid phase extraction, and barcode reading (1D and 2D). This flexibility allows labs to automate individual steps or entire workflows.
Our projects in the pharmaceutical industry often include third-party integrations with plate readers, washers, incubators, and imaging systems, among others. We also offer standardized solutions for some methods, such as PCR setup and cell maintenance. Moreover, our Automated Sample Management Systems can store samples in a wide variety of formats from ambient to -80 °C.
For laboratories conducting manual workflows, Hamilton offers a broad range of precision tools. This includes fixed- and adjustable-volume pipettes for general liquid handling, as well as manual Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC) syringes designed for reliable, high-precision sample injection across leading autosampler platforms.
Explore our Analytical Development and QC Solutions and Applications in Detail
Choose an outcome below to see personalized product recommendations.
The Hamilton Microlab Prep is an affordable liquid handler perfect for automating workflows. This entry-level liquid handler supports automated PCR setup and serial dilution.
The Hamilton Microlab STAR is a reliable and versatile automated liquid handling platform. With advanced features like multi-probe heads, pipetting technologies, and VENUS software, this premier liquid handling system fits your laboratory needs. Revolutionize your workflows with the STAR today!
Hamilton STAR V, a cutting-edge liquid handling robot, unites Microlab STAR flexibility with Microlab VANTAGE high-performance capabilities to boost efficiency. The Microlab STAR V offers speed, precision, and technology for automated liquid handling. Upgrade your lab—explore the Microlab STAR V!
Hamilton VANTAGE 2.0 is a cutting-edge liquid handling system with automated precision. Optimize workflows with the VANTAGE robot, all while boosting performance, safeguarding samples, and maximizing walk-away time. Discover the Hamilton VANTAGE liquid handler for your current & future needs.
Assay Ready Workstations
NGS STARlet
Compact and efficient, the entry-level NGS STARlet from Hamilton includes all the devices you need to automate sequencing library preparation of up to 24 samples at once with detailed precision, accuracy, and reliability.
Assay Ready Workstations
NGS STAR Line
Hamilton NGS STAR helps streamline next-generation sequencing in labs. Achieve full NGS automation for library prep, optimized for NGS assays and genome sequencing. Enhance efficiency, precision, and reliability in your workflows. Explore the Hamilton NGS STAR for seamless sequencing today!
Assay Ready Workstations
NGS STAR V
Automate NGS library preparation with the Hamilton NGS STAR V Assay Ready Workstation—optimized for demanding high-throughput genomic research.
Ambient, +4°C, -20°C Sample Storage
Verso Q-Series
Verso Q-Series automated freezer storage systems allow you to spend less time managing your samples. Verso Q20, Verso Q50, and Verso Q75 automated ambient to minus 20°C freezers feature large storage capacities in extremely compact footprints.
Ambient, +4°C, -20°C Sample Storage
Verso
Hamilton Verso is a modular compound management system for automated storage at temperatures from ambient to minus 20°C for high-throughput applications. This compound and sample storage system can easily be configured to meet your needs.
-80°C Sample Storage
SAM HD Pro
The SAM HD Pro lab freezer is your solution for high-density storage with a small footprint. This compact lab freezer is capable of ultra-low temperatures down to minus 80°C to ensure sample integrity. The SAM HD Pro sample freezer makes automated storage quick and easy.
-80°C Sample Storage
BiOS
BiOS is Hamilton’s premier minus 80°C freezer for medium- and large-capacity storage. This ultra-low temperature freezer maintains the integrity of your biological sample storage throughout automation. With customizable size and capacity, this minus 80°C freezer can be scaled to fit your storage needs.
Capping & Decapping
LabElite I.D. Capper
The LabElite I.D. Capper from Hamilton combines automated tube capping/decapping with high-speed barcode reading in one device.
Capping & Decapping
LabElite DeCapper
The LabElite DeCapper by Hamilton automates tube capping and decapping, improving efficiency and sample integrity.
Capping & Decapping
LabElite Handheld DeCapper
The LabElite Handheld DeCapper is a semi-automated device designed for efficient capping and decapping of tubes in 48- and 96-format racks.
Barcode Reading
LabElite I.D. Reader
The LabElite I.D. Reader by Hamilton automates barcode scanning for 2D-labeled tubes.
Syringe Applications
Manual GC and HPLC Syringes
Hamilton manufactures a wide range of syringes for HPLC and GC applications, including capillary and packed column methods, on-column and split/splitless injection techniques, and headspace sampling.
Syringe Applications
GC Autosampler Syringes
Hamilton maintains a large catalog of replacement syringes for the most popular gas chromatography autosamplers. The manufacturing process and quality assurance procedures ensure that every syringe we sell will provide superior accuracy and precision.
Good to Know About Analytical Development and QC Applications
This section provides a selection of additional resources related to the application described on this page. It includes helpful articles, videos, and blogs that offer deeper insights into the topic.
Hamilton Products in Action
A collection of videos showcasing Hamilton products in use, providing practical insights into their functionality and benefits.
/
/
Solutions for top 3 Challenges of the Analytical Development and QC Process
Challenge: GMP Compliance
Solution: All Hamilton platforms use our VENUS software, which is equipped with the necessary features for GMP compliance, including (i) controlled system access, (ii) sample traceability, (iii) time-stamped audit trails, (iv) data integrity, and (v) system documentation. Several of the methods developed by our customers on our systems during analytical development have been successfully transferred to QC under GMP conditions.
Challenge: Variety of Vial Types
Solution: Compound storage in Analytical Development and QC involves various vial types, formats, and storage conditions to accommodate different sample types and analytical workflows. Hamilton automated sample storage systems can store and handle a wide variety of vial types, including micro vials, microtubes, REMP tubes, acoustic tubes, glass vials, syringes, and bulk storage boxes for non-robotic-friendly containers.
Challenge: Limited Samples
Solution: Automated systems can use the same sample to run different assays in parallel, avoiding the need to use one sample per assay. Moreover, some of our automated systems have low-volume dispensing capabilities, allowing assay miniaturization.
Are the Assays for Analytical Development Different from Those Used in QC?
In general, analytical development creates and refines the assays that QC later implements and standardizes for routine use. The assays are closely related but serve different purposes.
Key Differences Between AD and QC Assays
Aspect | Analytical Development Assays | Quality Control Assays |
|---|---|---|
| Purpose | Characterization, method development, optimization | Routine testing, batch release, compliance |
| Validation Status | Not always validated (early stages), but validation is required before QC transfer | Fully validated, follows strict regulatory guidelines |
| Flexibility | High (methods can be adjusted) | Low (methods must remain consistent) |
| Regulatory Compliance | International Council for Harmonisation (ICH) Q2, ICH Q3 (method development) | ICH Q6, Good Manufacturing Practice (GMP) (batch release, stability testing) |
| Examples of Unique Assays | Forced degradation, High-resolution mass spectrometry (HRMS), structural characterization | NA, all are also done in analytical development |
How do analytical methods progress from Analytical Development to Quality Control?
Analytical methods typically undergo a structured progression to ensure they are robust, reliable, and compliant with regulatory and GMP requirements before being routinely used in Quality Control.
A simplified step-by-step outline would look like this:
Analytical Development (AD)
- 1. Method Development & Optimization
- 2. Method Qualification & Validation
- 3. Stability & Characterization Studies
- 4. Technology Transfer to QC
Quality Control (QC)
- 5. Raw Material & In-Process Testing
- 6. Finished Product Testing (Batch Release)
- 7. Stability Testing (Ongoing Compliance)
- 8. Regulatory & GMP Documentation
Analytical Development and QC Case Studies and Application Notes
Other Analytical Development and QC Resources
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Related Industries
Backed by world-class service and support.
For over 75 years, the Hamilton name has been recognized globally for its unwavering commitment to quality. That pledge extends to creating long-term customer partnerships. We're proud to offer in-depth training courses, on-site field support, custom product builds, and so much more.
Let's Talk
Connect with a Hamilton expert to discuss solutions for your workflow. We are here to enable your success.
Request Type: