BioPharm International-11-01-2013

A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.

An effective supplier-initiated change management process is discussed.

New regulation offers patients in Brazil greater access to experimental drugs.

Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.

Today, there is a global adoption of buying and selling used equipment. This article reviews what organizations should look for when considering the purchase of used equipment.

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

USP is developing and revising distribution standards in response to changes in the global supply chain.

The JOBS Act and FDASIA show early signs of accelerating drug development.

Data from BioPlan Associates' 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.

The authors discuss how to develop a cost-effective thermally protective packaging system.

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