BioPharm International, May 2024

Progression in biopharmaceutical drug development and manufacturing is being boosted by technological advances.

This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.

This commentary summarizes the derivation of clonal HEK293 suspension cell lines, selection of clones for rAAV production, and design of experiments-based optimization strategies for characterization of one clonal isolate for high yield rAAV manufacture. Data shown provides proof of concept for the success of this strategy, its applicability for manufacturing different rAAV serotypes and lays the foundation of further clonal cell line characterization for scale up of production.

Sterile filtration and use of sterile single-use materials provide the best solutions depending on vector size.

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

Technological advances are helping advance biologics development and manufacturing and reduce bottlenecks.

Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.