BioPharm International, March 2013 - BioPharm International

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BioPharm International, March 2013
Features
Advances in PAT for Parenteral Drug Manufacturing
By Patricia Van Arnum
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
By Patricia Van Arnum
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
By Susan Haigney
BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.
Overcoming Challenges in the Reconstitution of a High-Concentration Protein Drug Product
By Leu-Fen H. Lin, PhD , Richard Bunnell, PhD
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
By Anurag S. Rathore, PhD , Varsha Joshi , Nitin Yadav
Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.
From the Editor
Catching Up
By Rita Peters
A QbD paradigm advances process understanding in development and manufacturing.
Regulatory Beat
Vaccine Innovation Yields New Products and Processes
By Jill Wechsler
Vaccine development is benefiting from manufacturing advances.
European Beat
Europe and the United States to Negotiate a Free-Trade Agreement
By Sean Milmo
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.
Global Reports
Report from Brazil
By Hellen Berger
Brazil's major vaccine producer innovates with stem-cell research.
Perspectives on Outsourcing
Outsourcing Nontraditional Protein Expression Systems
By Eric S. Langer
Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.
Boot Camp Technical Guide
Lyophilization: A Primer
By Katriona Scoffin , Laura Ciccolini, PhD
Optimized freeze-drying cycles can offer scientific and business advantages.
Inside USP
Standards-Setting Activities on Impurities
By Maura Kibbey, PhD , Antonio Hernandez-Cardoso, MSc , Kahkashan Zaidi, PhD
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.

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