BioPharm International-01-01-2016

In semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.

Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.

mstay/Getty ImagesBiopharmaceutical manufacturing involves a series of complex unit operations linked together to provide high-purity, biologic actives with specifi

The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.

Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

Industry experts discuss what the outsourcing market holds for 2016.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.

This article defines the concept, justification, and method of removal of out-of-trend points in stability modelling and shelf-life prediction.

The authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.

Click the title above to open the BioPharm International January 2016 issue in an interactive PDF format.