Pharmaceutical Technology-05-15-2020

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.

Single-use processing requires instruments providing the accuracy of traditional technologies but configured in form factors designed specifically for this service

A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

Pharmaceutical Technology spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

Synthetic depth filters are a suitable option to provide a high-performance and scalable single-step clarification process.

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

Regulators have exaggerated expectations for simulated media fills.