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.

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Improving Documentation Change Control Process

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. Any changes made to the product, system or facility, (e.g., manufacturing, processing, quality assurance/quality control, information technology (IT), etc.) need to be documented in a timely manner. Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times.

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Personalized Medicine - Diagnostics Will Lead the Way!

Personalized medicine – diagnostics will lead the way!

We have been talking about Personalized Medicine for years. “Wouldn’t it be better if the medicine that I was taking was designed just for me?” We all know that personalized medicine would greatly benefit individual patients.

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Leveraging Design To Minimize Risk

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.

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Importance of Information Sharing in Cold Chains

Importance of information sharing in cold chains

To ensure the quality of pharmaceutical raw materials and products, it is very important to monitor specific factors throughout the supply chain. In cold chains, temperature is closely controlled and monitored.

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Building a Thoughtful Manufacturing Supply Chain

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.

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Understanding Waste From A Lean Biopharmaceutical Perspective

Understanding waste from a lean biopharmaceutical perspective

As pressure for biopharma manufacturers to cut costs continues to grow, implementing Lean and Six Sigma methodologies can eliminate waste and maximize profits.

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