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Overcoming Challenges in the Reconstitution of a High-Concentration Protein Drug Product

March 1, 2013

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

Aggregation of Monoclonal Antibody Products: Formation and Removal

March 1, 2013

Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.

Advances in PAT for Parenteral Drug Manufacturing

March 1, 2013

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Advancing Analytical Testing and Instrumentation for Biopharmaceuticals

March 1, 2013

As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.

The Lifecycle Change of Process Validation and Analytical Testing

March 1, 2013

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

Lyophilization: A Primer

March 1, 2013

Optimized freeze-drying cycles can offer scientific and business advantages.

Therapeutic Antibodies in Review

February 1, 2013

Innovative products and a range of indications drive the therapeutic antibody market.

Navigating Emerging Markets: Eastern Europe

February 1, 2013

Eastern Europe is moving towards a goal of harmonized regulations.

The Vaccine Scene

February 1, 2013

A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma.

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