Reagent Formulation

Life Science Outsourcing specializes in reagent formulation services, ensuring precision, stability, and regulatory compliance for diagnostic applications.

Precision Reagent Formulation
for Reliable Diagnostic Performance

As part of our end-to-end solutions, LSO delivers expertly formulated reagents with precision, stability, and scalability. From R&D to commercial production, we ensure consistent quality and full regulatory compliance—helping diagnostic manufacturers bring innovations to market faster.

What is Reagent Formulation?

Reagent formulation involves custom blending, mixing, and quality testing of chemicals and biological agents for diagnostic assays.

Custom reagent development: Tailored formulations for specific diagnostic applications.
Scalability: Production from R&D to commercial manufacturing.
Regulatory validation: Compliance with ISO and FDA standards for diagnostic reagents.

Who Needs Reagent Formulation?

Diagnostic manufacturers requiring high-quality reagents.
Biotech companies developing novel assays.
Research labs scaling reagent production for commercialization.

How Does Reagent Formulation Work?

Formulation Design & Optimization: Working with clients to create reagent compositions that meet sensitivity, specificity, and stability requirements.
Batch Production & Mixing: Utilizing precision equipment to ensure consistent formulation across small and large-scale production runs.
Quality Testing & Validation: Performing rigorous stability, potency, and performance testing to ensure consistency and effectiveness in diagnostic applications.
Regulatory Compliance & Documentation: Maintaining detailed documentation for batch records, material traceability, and adherence to global regulatory requirements.

What standards apply?

ISO 13485 – Quality management system for in-vitro diagnostics.
FDA 21 CFR Part 820 – Good manufacturing practice regulations.
IVD Directive (98/79/EC) – European regulatory requirements for diagnostic reagents.

Why LSO?

Expertise in reagent formulation with proven stability and consistency.
Scalable production from small batch to commercial-scale manufacturing.
Regulatory support ensuring seamless compliance and documentation.

Full EtO Validation

Comprehensive packages for regulatory compliance.

Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

Robust Qualification

Secure with 2X qualification.

Choice of PCDs

Tailored to your sterilization needs.