BioPharm International-03-01-2013

March 01, 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.

March 01, 2013

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

March 01, 2013

Vaccine development is benefiting from manufacturing advances.

March 01, 2013

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

March 01, 2013

Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.

March 01, 2013

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

March 01, 2013

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

March 01, 2013

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

March 01, 2013

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

March 01, 2013

A QbD paradigm advances process understanding in development and manufacturing.

March 01, 2013

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

March 01, 2013

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

March 01, 2013

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