BioPharm International-03-01-2013

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.

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

Vaccine development is benefiting from manufacturing advances.

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

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

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

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.

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

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

A QbD paradigm advances process understanding in development and manufacturing.

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

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.

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