The Advanced Virus Detection Technologies Interest Group (AVDTIG) is one of PDA’s newest interest groups. In the November/December issue of the PDA Journal of Pharmaceutical Science and Technology, read their commentary on high-throughput sequencing for virus detection.

Commentary

Arifa s. Khan, Dominick A. Vacante, et al., “Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts for High Throughput Sequencing (HTS) for Virus Detection”

David Bain, et al., “Risk Management in Biologics Technology Transfer”

Research

Michael Washabaugh, Patricia Cash, et al., “Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping”

Tobias Werk, et al., “The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes”

Patrick J. Faustino, et al., “Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry”

Ankit Patel, et al., “A Small-scale Model To Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization”

Harry Yang, Steven Novick, Richard K. Burdick, “On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation”

Technology/Application

Bernhard Hladik, Uwe Rothaar, Michaela Klause, “Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System”

Frank Günther, et al., “Sterility Testing of Injectable Products: Evaluation of the Growth-based BacT/ALERT® 3D™ Dual T Culture System”

Case Studies

Sal Giglia, et al., “Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters”