Product Characterization and QC Analytics

A scientist conducts product characterization and quality control (QC) analysis in a lab, working with a flow cytometer. The data on the screen displays detailed graphs and peaks, indicating an analysis of biological or pharmaceutical samples for purity, potency, and safety.

Product Characterization and QC Analytics Services

Pharmaron’s Gene Therapy team provides analytical capabilities for analysis of viral vectors and proteins from early phase to market authorization. Our analytical toolkit supports biological, physicochemical and biophysical characterization of CGT product modalities and addresses the unique challenges presented by advanced therapies.

Our team utilizes state-of-the-art analytical automation to increase sample throughput for process development and characterization studies. We have extensive experience of reporting and presenting analytical data to regulatory agencies in the USA, Europe, Japan, China and elsewhere.

A laboratory setup featuring advanced analytical instruments and computers for biopharmaceutical product characterization and quality control analytics.

Product Characterization

  • World class expertise in Gene Therapy analytical characterization and CQA assessment
  • Advanced analytical toolkit for product characterization, comparability and forced degradation studies
A lab scientist wearing protective goggles and a lab coat works with a Beckman Coulter centrifuge. He holds a rotor, preparing samples, with multiple monitors and scientific equipment surrounding him in a bright, modern laboratory.

Analytical Method Development

  • Method development with focus on using ultra-sensitive and small volume methodologies to tackle the difficult challenges faced with Gene Therapies
  • Significant phase-appropriate method validation and method transfer
A scientist in gloves prepares samples using a Bio-Rad automated droplet generator for product characterization and QC analytics.

Cell-based Bioassays and Molecular Biology

  • Droplet digital PCR capabilities providing the most accurate and best in-class data for Gene Therapies
  • Optimization of platform analytics and development of bespoke assays including gene expression/editing and functional potency assays for release, stability and in-process analysis
Scientists in a spacious laboratory use advanced analytical equipment and computers for biopharmaceutical product characterization and quality control analytics.

QC Analytics

  • Full range of analytics to support GMP Analytical and Microbiology testing in line with current EMA and FDA guidance
  • Method Lifecycle Management including Method Validation and Transfer
  • Reference standard qualification and characterization
  • Design and justification of phase appropriate product release specifications
  • Critical starting materials, drug substance and drug product release testing
A scientist uses a Solo VPE device to analyze a sample for product characterization and QC analytics in a biopharma lab.

Stability and Forced Degradation Studies

  • ICH and bespoke stability study design, execution and shelf-life assessment
  • Design and execution of forced degradation studies
  • Critical starting materials, drug substance and drug product release testing
A scientist in protective gear uses a pipette to prepare a sample for product characterization and QC analytics in a laboratory setting.

Additional Capabilities

  • Specialist knowledge in low endotoxin recovery studies
  • AAV and Plasmid analytical platform
  • Identification and risk assessment of critical quality attributes
  • Authoring CMC sections for regulatory submission
  • Low volume analytics