Pharmaceutical Technology Editors

Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.

Kraig Biocraft Laboratories, a developer of spider silk-based fibers, will open a new facility in Michigan to combine its research and production efforts.

A grant from the Bill & Melinda Gates Foundation will advance PnuVax’s pneumonia vaccine’s clinical development and biomanufacturing scale-up using a low-cost manufacturing approach.

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.

Die-cut strip packaging made with Romaco’s Siebler heat-sealing technology will be displayed at Constantia Flexibles’ booth (Stand 42H51) at CPhI Worldwide 2017.

The acquisition broadens the CDMO’s preclinical and clinical offering to include bioanalytical and drug discovery services.

DoKaSch Temperature Solutions, a Germany-based provider of climate-controlled air cargo containers, announced that its Opticooler air cargo containers are now available in the United States.

The US Department of Justice reports that AmerisourceBergen has pled guilty to illegally distributing misbranded oncology drugs and will pay a $260-million penalty.

Eurofins Scientific has opened a £4-million (US$5-million) pharmaceutical chemistry and microbiology facility in Livingston, Scotland, to support the company’s product and water testing businesses in the UK.

The draft guidance gives recommendations for reproductive toxicity testing and labeling.

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

AbbVie, Amgen, AstraZeneca, Bristol-Myerse Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

The agency will require training for healthcare providers who prescribe immediate-release opioids.

The International Society for Pharmaceutical Engineering (ISPE) has revealed the results of its 2017–2018 International Board of Directors election.

Fresenius Kabi broke ground on a previously announced $250 million expansion of its Melrose Park, IL, manufacturing facility.

EquipNet India, a subsidiary of EquipNet, a laboratory equipment supplier, celebrated its 10th anniversary in the surplus asset management market.

The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

Omya will be presenting its functionalized calcium carbonate for several applications at the show.

Solid state solutions provider Holodiag and fine chemical R&D provider Holochem join forces.

The Gx Elite vials are the result of comprehensive optimization measures in the conversion process, which have focused on designing out the risk to create product flaws during production including the removal of all glass-to-glass contact beginning with the tubing material all the way through final packaging.

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.

Mevopur anti-stat is tested to new stringent regulations and maintains anti-static performance at low humidity levels.