Analytical development sets the framework for how a drug substance and product will be assessed throughout its lifecycle. Methods are designed and validated to meet expectations from the FDA, EMA, and ICH, ensuring that measurements of identity, strength, purity, and stability are scientifically sound and appropriate for regulatory use.
Because analytical activities integrate directly with formulation and process development, they help establish specifications, support stability programs, and maintain consistency across manufacturing stages.
Core Activities Within Analytical Development
Analytical development spans a broad set of laboratory and data-generation functions. While individual programs differ, work typically includes:
Method Design and Technology Selection
Teams select appropriate instrumentation—such as HPLC, LC–MS, GC, spectroscopy, or electrophoretic techniques—based on the molecular characteristics of the drug substance and its impurities. Early feasibility studies determine whether an approach is fit for purpose.
Material and Impurity Characterization
Methods are established to measure assay, degradation pathways, impurity profiles, excipient compatibility, and structural attributes. These data help support formulation design and risk assessment.
Stability-Indicating Method Development
Stability-indicating methods are designed to separate and quantify active components and degradation products. Forced degradation studies (thermal, photolytic, oxidative, pH stress) help demonstrate that the analytical method can track changes over time.
Performance Assessment and Refinement
Once preliminary conditions are set, analysts refine parameters such as selectivity, resolution, robustness, and linearity. These refinements ensure methods can withstand expected variability in samples, instruments, and operators.
Documentation and Method Transfer
Completed methods are formalized in controlled documentation and transferred to receiving laboratories—internal QC units, external CMOs, or partner sites—using structured qualification or verification studies.
Analytical Method Validation
Method validation demonstrates that an analytical procedure performs reliably for its intended purpose. Regulatory agencies expect validation before methods are used for stability studies, release testing, or other GMP applications.
Typical Validation Parameters
A comprehensive validation program addresses:
- Accuracy – alignment of measured values with true values
- Precision – repeatability and intermediate precision
- Selectivity/Specificity – ability to distinguish the analyte from matrix components or impurities
- Linearity – proportional response across a defined concentration range
- Range – validated upper and lower limits appropriate for the analyte
- Limit of Detection (LOD) and Limit of Quantitation (LOQ) – lowest detectable and quantifiable levels
- Robustness – performance under small, deliberate method variations
- System Suitability – instrument-level checks confirming readiness for analysis
Validated methods provide confidence that stability studies, comparability assessments, impurity evaluations, and release specifications are based on reliable measurements.
Regulatory Considerations for Analytical Development
Analytical methods used in pharmaceutical programs must demonstrate scientific soundness and compliance with globally recognized standards. Current expectations reflect a lifecycle approach to method design, validation, and maintenance.
ICH Framework
- ICH Q2(R2) provides guidance for validation of analytical procedures.
- ICH Q14 outlines modern expectations for method development and establishes principles for structured, science-based design.
- ICH Q12 supports lifecycle management and change control for analytical methods and manufacturing processes.
Quality and Data Integrity Expectations
Regulators expect transparent, traceable documentation; adherence to cGMP and GLP requirements; and controls that support reproducibility across sites, operators, and instruments. Audit-ready data, well-defined procedures, and appropriately maintained instrumentation contribute to compliant method execution.
How Analytical Development Supports the Product Lifecycle
Analytical development contributes to decisions and activities from early research through commercial manufacturing, including:
- Setting and justifying specifications for drug substances and drug products
- Supporting formulation selection and compatibility studies
- Enabling real-time and accelerated stability studies
- Characterizing degradation pathways and impurity profiles
- Generating data for regulatory submissions and comparability exercises
- Providing methods that support release testing, in-process control, and ongoing product maintenance
These functions help ensure that products consistently meet their intended quality attributes and perform as expected throughout their shelf life.
Analytical Development at BA Sciences
BA Sciences supports analytical programs with method development, optimization, validation, and transfer services designed for cGMP environments. You can work with our team to generate reliable data throughout development and manufacturing, supported by instrumentation, controlled processes, and comprehensive analytical development services.
Since 1987, BA Sciences has provided analytical support to pharmaceutical, biopharmaceutical, medical device, consumer product, and repackaging organizations. Our laboratory offers cGMP-compliant operations, FDA and DEA registration, and ISO/IEC 17025:2017 accreditation for microbial count testing on water, raw materials, and pharmaceutical products.
Contact us to discuss analytical development needs and explore how our laboratory can support your program.