Conferences & Fairs

Poster Presentation: May 9, 2024 | 12pm | Exhibit Hall
AAV Vectors - Virology and Vectorology
Presented by: Kaitlyn Knapp, Scientist I, Eurofins BioPharma Product Testing
Replication competent virus testing is required by regulations for viral vector manufacturing to ensure the safety in resulting therapies. The regulations require that replication competent (rc) virus is monitored in virus seeds, unprocessed bulk (harvest), and drug substance (purified bulk). Adeno-associated virus (AAV) is a commonly utilized vector in many gene therapies. AAV vectors are designed to infect human cells and deliver the therapeutic genome in a specific area for the target condition without viral replication. Serotypes are key to the tissue selectivity. Vectors are modified to prevent replication. Therapies must be monitored for the presence of replication-competent adeno-associated viruses (rcAAV), which could result in unintended side effects. Safety testing can be conducted to establish the presence of rcAAV in an intended sample, but many current methods are specified to AAV serotype 2 (AAV2) vectors. Serotype specificity is a challenge for methods, which include a cell-based assay to amplify any replication competent virus present. We sought to explore methods for other AAV serotypes in order to offer an rcAAV method across multiple serotypes. For successful platform method development, understanding the infectivity of individual serotypes with the target cells used in the replication competent methods is required. To expand the scope of the established rcAAV assays, AAV serotype 5 (AAV5), serotype 8 (AAV8), and serotype 9 (AAV9) were tested on cells from various tissue types. The standard for GMP testing with AAV2 is performed on HEK293 cells. Other cell lines were tested to expand testing alternatives. AAV serotypes expressing GFP (Green Florescent Protein) were used to infect HT1080, HeLa, and HEK293 cells. HT1080 cells acted as a control due to prior success across AAV5, AAV8, and AAV9. A range of Multiplicity of Infections (MOIs) for each serotype was tested to identify their individual infection sensitivity. Our results indicate that serotypes beyond AAV2 can infect cells that are suitable for rcAAV testing. These findings will expand rcAAV assay capabilities and the diversity of AAV serotypes that can be tested.

Presentation: May 10, 2024 | 4:30pm | Exhibit Hall - Presentation Theatre 
From Days to Hours: The Dynamic Shift in Mycoplasma Testing
Presented by: Dr. Jonathan Demick, Principle Scientist, Eurofins BioPharma Product Testing
Testing methods for detecting mycoplasma have evolved over time with improved technologies and new drug modalities. Traditional compendial testing for mycoplasma includes direct culture and indicator cell culture methods and are still the gold standard for mycoplasma detection. These methods are not conducive to newer autologous cellular therapies, therefore, Nucleic Acid Techniques are becoming more accepted. Join us for this presentation to gain insights into the significance of mycoplasma and how the industry has adapted to support increasingly complex therapeutic modalities.

Tobias.Mejer@bpt.eurofinseu.com