Bioanalytical Case Studies and Success Stories

Explore how SmartBio Analytics has supported pharmaceutical and biotechnology organisations through tailored bioanalytical solutions, fast turnaround times and reliable analytical results.

CASE STUDY 1

Rapid Method Development for an Urgent Preclinical Study

Rapid Method Development for an Urgent Preclinical Study

Challenge

A biotech company needed to initiate a preclinical PK/TK study in less than three weeks but had no validated method for their innovative small molecule.

Our Approach

Developed and qualified an LC/MS method in just 10 days, including optimization for sensitivity in plasma.

Outcome

The client was able to start dosing on time, avoiding costly delays in their development plan.

CASE STUDY 2

Multi-Steroid Biomarker Panel in Oncology Research

Multi-Steroid Biomarker Panel in Oncology Research

Challenge

An academic group required simultaneous quantification of over 15 steroid hormones as biomarkers in a cancer study, with high specificity to avoid cross-reactivity. 

Our Approach

Designed and validated a multiplex LC/MS, ensuring robustness across different matrices.

Outcome

Provided high-quality data within 5 days of sample receipt, enabling timely inclusion in a key grant submission.

CASE STUDY 3

Supporting a Clinical CRO in a Bioequivalence Study

Supporting a Clinical CRO in a Bioequivalence Study

Challenge

A clinical CRO partner without internal LC/MS capacity needed rapid turnaround for >1,000 plasma samples in a generic drug bioequivalence trial. 

Our Approach

Integrated seamlessly into the CRO’s workflow, applying an existing validated method from our Non-Proprietary Assays repository. 

Outcome

Delivered all results ahead of schedule, supporting a successful regulatory submission.

CASE STUDY 4

Oligonucleotide Biodistribution Analysis

Oligonucleotide Biodistribution Analysis

Challenge

A pharmaceutical client developing a GalNAc-conjugated siRNA required biodistribution data in multiple tissues.

Our Approach

Developed and validated a sensitive LC/MS method for the intact oligonucleotide, optimizing extraction for different tissue types. 

Outcome

Generated data that informed lead candidate selection, shortening the preclinical decision-making process.

At SmartBio Analytics, each project is an opportunity to deliver fast, reliable, and compliant bioanalytical solutions — tailored to our partner’s unique needs.