Manufacturing

Criticality is used as a risk-based tool to drive control strategies.

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

Almac releases an enhanced third-party logistics customer billing application.

GlaxoSmithKline plans to invest nearly $41 million to expand its operations at its facility in Montrose, the United Kingdom.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

Merck KGaA plans to build a new biomanufacturing facility in Nantong, China.

Phase I/II study to evaluate treatment of patients with melanoma using Pfizer’s palbociclib and GSK’s trametinib.

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing based biosafety assessments to detect and identify viral contaminants within biologic compounds.

Ei Lilly announces investments in insulin manufacturing capacity for its sites in Indianapolis, Puerto Rico, France, and China.

Schott’s glass vials are specially manufactured to control and reduce delamination potential.

AstraZeneca will build a new facility in the United Kingdom to produce Zoladex, an injectable prostrate cancer treatment.

Lyra Myers, associate director and value creation agent at Roche, has been elected DCAT president.

Grifols expands and diversifies portfolio with acquisition of diagnostic business.

ISPE’s survey is industry’s first large-scale effort to collect data on patient experiences with clinical trial materials.

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.

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

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.

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.

Genzyme will build a facility in Massachusetts to expand purification capacity for Fabrazyme (agalsidase beta).

Roche plans multimillion biologic manufacturing expansions in California, Switzerland, and Germany.

PhRMA report reflects robust R&D in vaccine development.

The sterile injectable manufacturer Ben Venue decides to end production despite efforts to remediate cGMP violations.

Advanced Biosciences Laboratories will support the development and production of a novel Shigella vaccine candidate for PATH.

The first part of CPhI's Annual Expert Industry Report examines ADCs, single-use technology, and regulatory failure.

GlaxoSmithKline?s sale of its thrombosis brands is part of a focus on its late-stage pipeline.

Fujifilm Diosynth Biotechnologies? new mammalian cell-culture facility uses primarily single-use technologies.

Manufacturing standards are considered key to preventing drug recalls and shortages.