Cambridge Healthtech Institute’s 2nd Annual

Cell and Gene Therapy Analytics

Accelerating Development of CGT Products

14 November 2022

A vast number of mainstream and emerging biotechs are now engaged in the discovery and development of cell and gene therapies, but significant advances in analytical and bioanalytical technologies are required to support R&D, preclinical and clinical development of these novel modalities. The 2nd Annual Cell & Gene Therapy Analytics at PEGS Europe will highlight the analytical strategies, stability, potency, product- and process-related impurities of AAVs, lentivirals, cell therapies, and non-viral gene therapies.  

Coverage will include, but is not limited to:

Characterising Viral Proteins

• Capsid titer
• Assessing empty/full/partial capsids
• Determining particle size distribution and characterisation
• Capsid protein variants and strain confirmation
• MAM assessment of AAV
• Stability differences of AAV serotypes
• Primary and higher order structures of AAV Vectors
• Characterising lentiviral vectors

Process-Related Impurities and Residuals

• Identification, quantification, monitoring, and control
• Risk assessment of HCPs and Residual DNA
• Regulatory guidance for residual DNA and protein

Characterising DNA/Viral Genome

• Viral genome titer
• Genome integrity and purity, identity
• PTM analysis by peptide mapping

Cellular Therapies

• Analytical strategies and quality control
• Determining CQAs
• Cell viability and ISO cell counting standards
• Starting material characterisation
• Cryopreservation challenges

Potency Assay Development

• Assays to determine biological activity, potency matrix in cell and gene therapies
• AAV infectivity

Safety & Efficacy Testing

• Assessing efficacy of rAAV therapies
• Replication competent AAV (rcAAV) detection to ensure biosafety

The deadline for priority consideration is April 8, 2022.

All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

Opportunities for Participation:

• To submit a podium presentation, please click here.
• To become a sponsor, click here.
• To present a poster, click here.
• To sign up to attend, click here

For more details on the conference, please contact:

For sponsorship information, please contact:

Companies A-K
Jason Gerardi
Sr. Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5452
Email: jgerardi@healthtech.com

Companies L-Z

Ashley Parsons
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1340
Email: ashleyparsons@healthtech.com

Conference Programs

• Display of Biologics
• Engineering Antibodies
• Machine Learning: Part 2

• Antibody-Based Therapies
• Emerging Targets & Approaches
• Membrane Protein Targets

• Safety & Efficacy
• Advancing Multispecifics
• Engineering Bispecifics

• Modulating the TME
• Innovative CAR T Therapy
• Next-Gen Immunotherapies

• Optimisation & Developability
• Analytical Characterisation
• Protein Stability & Formulation

• Data Science & Engineering
• Optimising Expression
• Process Development

• Intro to Machine Learning
• Machine Learning: Part 1
• Machine Learning: Part 2

• Antibody-Based Therapies
• Engineering Conjugates
• Next-Gen Immunotherapies