Biopharm Business - BioPharm International

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Biopharm Business
Insight and analysis to business aspects of biopharmaceutical development. Mergers, acquisitions, legal activities.

Using a Systematic Approach to Select Critical Process Parameters

July 1, 2012

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.

Know the Regulations

June 1, 2012

The contract provider needs to know as much as the NDA holder.

Developing Discoveries into New Therapeutics

June 1, 2012

Formulators and developers are at the heart of the industry's basic premise—they are saving lives.

Interview with FDA: Adopting New Strategies to Oversee Global Economy

June 1, 2012

In a special anniversary interview, Washington Editor Jill Wechsler speaks with with FDA Deputy Commissioner Deborah Autor about where the agency is headed.

25 Years of BioPharma Industry Growth

June 1, 2012

A review of key industry shifts and promises for the future.

Creating a Product Portfolio from the Ground Up

June 1, 2012

Mike Clayman, CEO of Flexion Therapeutics, talks about his company's strategy to focus on a single therapeutic area.

Determining Process Quality Metrics for CMOs

June 1, 2012

Implementing quality by design makes the determination of quality metrics across CMOs and sponsors essential.

Reducing Human Error

June 1, 2012

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

Developing Alternatives to ELISA-Based Biomarker Assays

June 1, 2012

The authors discuss a new, rapid immunoassay for the detection of biomarkers.

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