Biologics and Viral Analytics and Characterization

Pharmaron’s Gene Therapy CDMO, located in Liverpool, UK, provides analytical capabilities for analysis of biologics and viral vectors from early phase to market authorization. Our analytical toolkit supports biological, physiochemical and biophysical characterization of all biologics 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.

View as PDF: Biologics and Viral Analytics and Characterization

Download Poster: AAV9 Forced Degradation Capabilities

Download Poster: Advancing Adeno Associated Virus (AAV) Product Quality Through Use of In line PAT in Downstream Processing (DSP) with Potential to Significantly Reduce Process Development Timelines

Services

• Method development with focus on using ultra-sensitive methodologies
• Development of platform and bespoke analytics including bioassays for release, stability and in-process analysis
• Analytical release testing using our validation ready AAV and recombinant protein platform analytical release kit
• Phase-appropriate method validation and method transfer
• Process characterization expedited with use of high-throughput techniques
• Stability study design, execution and shelf-life assessment
• Specialist knowledge in low endotoxin recovery studies
• Advanced analytical toolkit for product characterization, comparability and forced degradation studies
• Identification and evaluation of critical quality attributes
• Design and justification of phase appropriate product release specifications
• Critical starting materials stability and release testing
• Authoring CMC sections for regulatory submission

Capabilities

• Intact mass analysis
• Peptide mapping
• CE-SDS
• AUC
• AEX-HPLC
• Cryo-EM
• Mini-TEM
• ddPCR
• Capsid ELISA
• SEC/RP-LC-FLR
• Mini-TEM
• AUC
• SEC
• DLS
• DSC
• Infectivity
• Transgene quantity (CBPA, ddPCR)
• Functionality (flow cytometry, microscopy)

Learn more about Pharmaron’s expertise by registering for our monthly CGT webinar series, which is focused on identifying key cell and gene therapy questions that arise during drug discovery and development. Register here.