January 2015 Editorial Line-up

Focus: Manufacturing and Equipment Trends
The editors examine current practices and emerging trends for a range of bioprocessing development and manufacturing processes. A survey of the audience will reveal the use of single-use systems versus stainless steel or hybrid systems, the adoption of process analytical technologies, and challenges with transitioning to continuous manufacturing. In addition, readers will evaluate the performance of upstream, downstream, and other manufacturing technologies and report on technology areas that need to improve to facilitate bioprocessing.

Upstream Processing: Fermentation
Cynthia A. Challener, Contributing Editor
Microbial fermentation, although an established technology, can offer many advantages for the production of a variety of APIs, including proteins and secondary metabolites. In many cases production times are lower and yields are higher than possible with mammalian cell expression. Continued advances in fermentation technology are further expanding its application. This article discusses some of the recent advances and the benefits they provide.

Downstream Processing: Affinity Media Advances in Affinity Media Techniques
Affinity purification of antibodies from blood serum is discussed in this column from experts in the field.

QUALITY/ANALYTICS

Process Validation
Rizwan Sharnez of Amgen discusses the challenges in process validation for biopharmaceuticals.

Biosimilar Analysis
Cynthia A. Challener, Contributing Editor
The key to regulatory approval for biosimilars is demonstration of comparability to the corresponding branded biologic drug. The structural, physicochemical, and biological properties of the biosimilar must be evaluated and shown to be similar to those of the original biologic API. Characterization of the protein structure, potency, stability, impurity profiles, and immunogenicity must be achieved. Ligand-binding assays (LBAs) are used to assess the pharmokinetic behavior of biosimilars. This article reviews strategies for implementing effective LBAs for biosimilar testing.