Biotechnology Archives

Closing the deal: Understanding when to close your process

When to close your pharmaceutical process

Too often, the term “closed process” is thrown around without an understanding of the salient issues. Pharmaceutical process closure can certainly provide many benefits, but there are various impacts and requirements depending on the ultimate goal and the specific process you are trying to close.

To outsource or not to outsource? That is the question: How to ensure your CMO stacks up

How to choose a contract manufacturing organization

The age-old debate of whether to outsource production to a contract manufacturing organization (CMO) remains for mature, emerging and virtual biopharmaceutical companies.

Improving documentation change control process

In regulated environments, companies are expected to establish procedures for document change control as a way of ensuring product quality and safety.

Leveraging biotechnology facility design to minimize risk

Learn how the application of best practice design principles can help mitigate the risks confronting biotechnology companies when navigating the uncertainty surrounding the demand profile of the product pipeline.

Building a thoughtful manufacturing supply chain

In the past 5 years, the biopharmaceutical industry has seen unprecedented change. Precipitated by the need to support a global client base with products that are more targeted, efficacious and cost-effective, the challenge to have a robust manufacturing supply chain is more crucial than ever to a company’s survival.