Simon Chalk

Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.

Benchmarking can be a useful tool to improve manufacturing practices.

Improvement strategy should be linked to business strategy.

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

A one-day sign off for batch records is considered a best practice in the industry.

Leading industry collaborators outline top 10 best practices for human error reduction.

A closer look at elastomer changeout times provides one example of using industry knowledge to improve operations and cost.

Introducing a new way to think about sharing information in a patent-driven industry.

The authors re-examine environmental controls in the context of technical advances in manufacturing.