Built for Confidence Analytical Development
Full lifecycle analytical development for biologics, from early characterization through validated methods and commercial release testing.
Value
Build Confidence in Every Result
Designed for data you can rely on
Analytical methods are developed to deliver consistent, reproducible insights across every stage of your program.
Aligned with process and manufacturing
Analytical development runs in parallel with process development and manufacturing to support coordinated decision-making.
Built for regulatory expectations
Methods and documentation are structured to support IND, BLA, and post-approval requirements.
Continuous across your program
A single analytical team supports your program from early development through
commercial release.
CAPABILITIES
Comprehensive
Analytical Capabilities
A complete analytical toolkit
Potency & bioactivity: Cell-based and binding assays measuring biological activity across development and release.
Physicochemical characterization: Assessment of molecular weight, charge variants, aggregation, and higher-order structure.
Glycan & PTM analysis: Glycosylation profiling and post-translational modification analysis.
Primary structure analysis: Peptide mapping and sequence confirmation using LC-MS/MS.
Stability testing: ICH-compliant stability studies supporting shelf life and formulation decisions.
CGMP release testing: Validated testing for identity, purity, potency, and safety for clinical and commercial batches.
PROCESS
Regulatory-Aligned
from the Start
Built for IND, BLA, and beyond
Avid’s analytical development programs follow a lifecycle approach aligned with ICH Q2(R1), ICH Q6B, and global regulatory expectations.
Methods are developed, qualified, and validated with regulatory requirements in mind, ensuring your analytical data package is ready to support submissions and inspections.
BUILT FOR EVERY STAGE OF YOUR PROGRAM
From Early Characterization to Commercial Release
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01
Early Phase ,
IND-enabling characterizationInitial molecule characterization and method development supporting IND submission.
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02
Clinical Phase ,
Method qualification & releasePhase-appropriate method qualification and analytical testing for clinical CGMP batches.
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03
Late Phase ,
Method validationFull ICH-aligned validation supporting BLA submission and regulatory review.
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04
Commercial ,
Release & lifecycle managementValidated release testing, stability programs, and ongoing method lifecycle support.
BENEFIT
One Analytical Thread
Across Your Program
Analytical development is not a standalone activity, it is a continuous thread that connects development, manufacturing, and regulatory success.
At Avid, analytical insights inform process development, support manufacturing decisions, and generate the data required for regulatory submissions, all within a single, integrated program.
Why Us
Why Avid Bioservices
Full Lifecycle Analytical Support
From early characterization through commercial release testing.
Integrated with Process Development
Analytical and process teams work together to inform decisions.
Regulatory-Ready Documentation
Methods and reports built to support IND, BLA, and inspections.
Phase-Appropriate Approach
Development and validation aligned to program stage.
US-Based, FDA-Experienced
Analytical work performed in domestic, inspection-ready facilities.
End-to-End Continuity
Seamless connection to manufacturing and quality systems.
Start your analytical
development program
Tell us about your molecule and goals. We’ll design an analytical strategy to support
your program from development through commercial release.
Learn More
Analytical Development FAQs
IND submissions require methods demonstrating identity, purity, potency, and safety, including structural characterization, impurity analysis, and preliminary stability data.
Method qualification demonstrates suitability for early clinical use, while validation confirms full performance according to regulatory standards such as ICH Q2(R1).
Potency assays measure biological activity and are critical for demonstrating efficacy, ensuring consistency, and supporting regulatory approval.
ICH Q2(R1) is the global guideline defining requirements for analytical method validation, including accuracy, precision, specificity, and robustness.
Stability studies rely on validated, stability-indicating methods to detect changes in product quality over time.
Yes. Avid provides integrated analytical development from early-stage characterization through commercial release and lifecycle management.