Downstream Development

OVERVIEW

Stability Studies

At Catalent, we know that your clinical viral vector batches are subject to increasing regulatory standards for product safety, including purity and potency. As experts in viral vector manufacturing, we understand the need to optimize your cell harvest and viral purification for meeting growing regulatory demands and increased timeline pressures.

Our wide array of analytical capabilities to assess product quality and guide downstream development efforts (HPLC/UPLC, qPCR and ddPCR, capillary electrophoresis (SDS-PAGE, IEF), immunoassays, dynamic light scattering, cell-based bioassays, and electron microscopy) will be evaluated and customized for your product and process.

Downstream development capabilities include:

• Harvest, lysis, and clarification
• Column and membrane chromatography
• Ultracentrifugation
• Recombinant/Wild-Type Viruses (adenovirus, AAV, HSV, RSV, CMV, Zika)
• Polysaccharide conjugates enveloped and non-enveloped virus-like particles (HPV, CMV, JCV, BKV, VEE, HIV, Ebola)
• Column and membrane chromatography (affinity, ion exchange, hydrophobic interaction, mixed-mode)
• Bioprocess filtration (tangential flow, hollow fiber, depth filtration)
• Centrifugation (low speed (Unifuge) and ultracentrifugation)
• Development of closed-system processes for therapeutic product types that are not amenable to sterile filtration including performance of process simulation studies

STABILITY STUDIES

At Catalent, we know that your clinical viral vector batches are subject to increasing regulatory standards for product safety, including, purity and potency. As experts in viral vector manufacturing, we will help you optimize your cell harvest and viral purification to meet growing regulatory demands and increased timeline pressures.

All of our Gene Therapy testing includes appropriately qualified stability-indicating test methods for purity, identity, and potency as defined during development or provided by the client.

Other tests often included in these studies are appearance, pH, and sterility/bioburden (at least initially and at study conclusion). The goal of these studies is to demonstrate the extent to which product quality varies with time under different conditions such as temperatures and humidity.

Storage conditions available for these stability studies include:

• Vapor phase liquid nitrogen (below -135°C)
• -80°C
• -30°C
• -20°C
• 2°C to 8°C
• 25°C
• 30°C
• 40°C