Built for Stability Formulation Development
Liquid drug substance formulation for biologics, designed for stability, shelf life, and real-world use from development through regulatory submission.
Value
Design a Formulation That Performs
Built for stability & shelf life
Formulations are designed to maintain integrity, potency, and quality from manufacturing through patient use.
Data-driven 
formulation design
Biophysical and 
analytical insights guide formulation decisions from the earliest stages.
Aligned with regulatory expectations
Stability studies and documentation support IND and BLA submissions.
Integrated with analytical development
Formulation and analytical teams work together to generate stability-indicating data throughout the program.
Stability & Performance
Designed for Real-World Conditions
Stability-focused design: Formulations are optimized to minimize aggregation, degradation, and loss of potency.
Product quality alignment: Critical quality attributes are monitored and maintained throughout development.
Scalable formulation strategies: Conditions are designed to translate into manufacturing without rework.
Patient-ready considerations: Formulations are developed with administration route and usability in mind.
FORMULATION CAPABILITIES
Comprehensive
Formulation Toolkit
Excipient screening & selection: Systematic evaluation of buffers, pH ranges, and excipients using DoE methodologies.
Forced degradation studies: Targeted stress testing to understand degradation pathways and inform formulation design.
Biophysical characterization: DSF, DLS, SEC, and complementary tools assessing stability and aggregation behavior.
High-concentration formulation: Optimization for subcutaneous delivery, including viscosity and stability challenges.
Lyophilization development: Cycle development and optimization for freeze-dried drug substance where required.
ICH stability studies: Real-time and accelerated studies supporting IND and BLA submissions.
Our Process
From Screening to Stability Data
-
01
Molecule assessment 
& pre-formulation
Initial characterization and screening to identify promising formulation.
-
02
Stress testing & degradation analysis
Evaluation of stability under controlled stress conditions.
-
03
Formulation 
optimization (DoE)
Systematic refinement of formulation parameters.
-
04
ICH stability
studiesInitiation of real-time and accelerated studies using validated methods.
-
05
Regulatory 
documentation
Preparation of stability data packages and reports for regulatory submission.
Scope & Integration
Focused scope. 

Connected program.
Avid provides formulation development 
for liquid drug substance.
This work integrates directly with analytical development and CGMP manufacturing, supporting a consistent development pathway. For drug product formulation and fill/finish, Avid collaborates with external partners to support your broader program strategy.
Formulation
One Formulation. 

Built to Last.
Formulation development defines how your biologic performs over time, during storage, transport, and administration.
At Avid, formulation is developed in coordination with analytical and process development, ensuring your stability strategy is supported by robust data and aligned with your full program.
Why Us
Why Avid Bioservices
Analytically Integrated Approach
Formulation and analytical development evolve together.
Full Lifecycle Support
From early screening through BLA stability packages.
DoE-Driven Methodology
Efficient, data-rich development supporting confident decisions.
Manufacturing Alignment
Formulations designed to scale 
intoCGMPproduction.
US-Based, FDA-Experienced
Domestic facilities with strong regulatory track record.
Transparent Scope
Clear focus on liquid drug substance, with guidance on downstream steps.
Start your formulation
development program
Tell us about your molecule and stability goals. We’ll design a formulation strategy built for performance and regulatory success.
Learn More
Formulation Development FAQs
DSF measures thermal stability, while DLS assesses particle size and aggregation , both providing insight into formulation performance.
Real-time stability studies typically run 12–36 months, with accelerated studies conducted in parallel to support early development timelines.
Avid focuses on liquid drug substance formulation. Fill/finish and drug product manufacturing are supported through external partners.
Formulation determines stability, shelf life, and product performance , ensuring the biologic maintains quality from manufacturing through patient use.
Excipient screening evaluates buffers, pH ranges, and stabilizers to identify conditions that best support stability and product quality.
Forced degradation studies expose a biologic to stress conditions such as heat or oxidation to understand degradation pathways and inform formulation design.