02.22.24 -- When In The Product's Life Cycle Does Continuous Manufacturing Make Sense?

Here, we compare two of the more common methods for container closure integrity testing: high voltage leak detection (HVLD) and vacuum decay.

Immunogenicity testing strategies and methodologies are well-established, but we need new approaches to data handling and analysis to streamline reporting.

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

More than ever, the quality functions in biopharma manufacturing are under pressure due to regulatory and political scrutiny combined with a global market rife with complex quality standards.

Innovative drug-eluting implants, inserts, and transdermal films delivering biologics and small molecules can meet the goals of patient-centric therapies, improved medicine, and better healthcare economics.

Although most legislation concerning the traceability of pharma products focuses on serialization rather than aggregation, the latter is an essential component of internal and external traceability of products.

As demand for capabilities and resources grows throughout a project, both become strained in-house, and the scale-up process becomes a steeper hill to climb.

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceutical products in development and clinical trials — all from one partner.

Examine how leveraging a fully robotic aseptic filling system enables versatility, high yields, and low losses, as well as precise and repeatable fill parameters batch to batch.

Delve into more detail and description of Lonza-owned toolbox technology, along with the technologies from Lonza's current partners, highlighting some key features.