Agnes Shanley

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

As downstream bioprocessing improvements continue, efforts are underway to integrate downstream processes into continuous operations.

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

A plant inspection backlog caused by COVID-19 restrictions threatens innovation and public health. Now pressured to step up on-site inspections, will FDA embrace new methods?

The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control.

More collaboration and a knowledge-based approach, driven by better analytics and high-throughput system integration, are reducing the risk of failure.

Branching out from roots in industrial biotechnology, Riffyn Data Systems (and its CEO Tim Gardner) is taking the message of data-driven process improvement to biopharma.

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

Determining the root cause of out-of-specification (OOS) and other problems requires a careful, deductive approach and a clear understanding of processes.

Better understanding and control of cell behavior is yielding benefits, upstream and beyond.

Core functions and those funded by fiscal year 2018 user fees are continuing, and 59% of the agency’s staffers are being retained.

Research suggests that working with a single contract partner can reduce development time and improve economics.

Despite the challenges and high cost of development, vaccine innovation is at an all-time high, as new approaches aim to improve global access.