Pharmaceutical Technology Editors

UPS’ 2015 “Pain in the Chain” survey suggests that pharma companies are getting better at product protection, cold chain and regulatory compliance, but need to improve cost control and planning for unexpected events. Lack of transparency and “too many handoffs” remain major challenges.

Expansions at Catalent’s Kansas City, MO, and Madison, WI facilities made in response to industry demand.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

Charles River Laboratories announces the acquisition of Oncotest GmbH.

Merck KGaA announces the completion of the acquisition of Sigma-Aldrich, a St. Louis-based life-sciences and technology company.

Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.

BioOutsource releases informational video detailing issues associated with ADCC assays and how to effectively analyze them.

The agency issues guidance on the labeling of over-the-counter products that contain acetaminophen.

The new executive director of the European Medicines Agency begins appointment.

GE Healthcare Life Sciences and Emerson Process Management collaborate in biopharmaceutical manufacturing processes.

High-dose axalimogene filolisbac immunotherapy will advance to expansion phase.

An ABPI report found a lack of quality candidates for high-skilled roles in areas such as bioinformatics, translational medicine, clinical pharmacology, and pathology.

FDA seeks feedback on possible analytical standards and approaches to optimize regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests.

Roche will invest in Switzerland but leave sites in Ireland, Spain, Italy, and the US as it focuses on lower-volume, specialized medicines.

Consort Medical has combined and integrated Aesica’s drug formulation, manufacturing, and packaging capabilities with Bespak’s drug-delivery device design, development, and manufacturing services to create a global single source drug and device contract manufacturing partner for the pharmaceutical industry.

Under the terms of the agreement, Daewoong will annually purchase minimum API quantities of erdosteine of approximately EUR 25 million from Edmond Pharma, a Recipharm Group company.

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.

AstraZeneca’s solid-dose facility in Taizhou, China received ISPE’s FOYA 2015 Overall Winner award.

Industry veteran Mark Kontny joins board of directors at Grand River Aseptic Manufacturing.

Almac is investing GBP16 million to expand its formulation and analytical development services and has successfully negotiated to operate in the Charnwood Campus in Loughborough, England.

This investment comes in response to the increasing demand for high quality and safe pharmaceutical packaging. rlc already has two pharma packaging centers in Rüdersdorf near Berlin, Germany and in Poznan, Poland.

The European agency presents guidelines for conducting post-authorization efficacy studies.

GE Healthcare's KUBio prebuilt modules were shipped from Germany to JHL Biotech in Wuhan, China.

The latest revisions to the international pharmacopoeia standards for glass pharmaceutical packaging have emphasized the importance of assessing delamination propensity of pharmaceutical glassware, including bottles, vials, cartridges, and syringes.

BASF’s new multi-product amines plant in Ludwigshafen, Germany meets growing demand for amines in various applications, including pharmaceuticals.

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.