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Lyophilization: A Primer

March 1, 2013

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

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.

Report from Brazil

March 1, 2013

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

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.

Report from India

February 1, 2013

India's biopharmaceutical industry is valued at $2 billion a year with 20 companies producing biosimilars and 50 products available in the domestic market.

Automated Concentration and Diafiltration of Multiple siRNA Samples

February 1, 2013

Project: transfer a manual concentration/diafiltration process for siRNA production.

The Vaccine Scene

February 1, 2013

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

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