Quality Oversight During Sterile Filling Operations

A continuous biomanufacturing platform can process higher/lower quantities of a drug as needed and allow manufacturers to respond to changing markets.

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

This paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.