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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.

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.

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.

Report from Brazil

March 1, 2013

Brazil's major vaccine producer innovates with stem-cell research.

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.

Lyophilization: A Primer

March 1, 2013

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

Viral Vaccine Manufacturing

February 1, 2013

Tony Hitchcock of Cobra Biologics discusses challenges posed by production of viral vectors for vaccines.

Therapeutic Antibodies in Review

February 1, 2013

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

Assessing Development Needs for Biobetters and Biosimilars

February 1, 2013

Development requirements and regulatory guidance for biosimilars and biobetters.

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