Compliance Notes - BioPharm International

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Compliance Notes

On the Horizon: New Expression Systems to Become Common Industry Platforms

June 1, 2009

New expression systems compete for attention.

When Less is More: Lean Can Help Reduce Costs and Improve Compliance Simultaneously

May 1, 2009

Use Lean techniques to improve manufacturing compliance

Serving Two Masters: Reconciling EMEA/GAMP 5 and FDA/cGMP Phase 1

January 1, 2009

QbD can help satisfy FDA and EMEA requirements.

The Company at the Crossroads. Part 1: To Commercialize or Not?

September 1, 2008

Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.

Coming to a Biotech Near You: Quality by Design Part 2: Design Space in Development and Manufacturing

July 1, 2008

Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.

Coming to Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals

May 1, 2008

The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.

How to Ensure Smooth Technology Transfer

March 1, 2008

A comprehensive process and analytical transfer package can speed up your product's time to market and save costs.

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