FDA strengthens sterile injectable drug inspections

Scott Gottlieb, commissioner of the US Food and Drug Administration, said new protocol of inspection has been designed to modernise the agency’s oversight and reporting of inspections at manufacturing sites

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ADC Bio secures additional equity round investment

Extra funding for strategic move into downstream formulation, fill-finish capabilities and full exploitation of Lock- ...

Novasep opens viral vector production plant in Belgium

Production of first batches at new EUR27m, cGMP manufacturing facility is due in early 2019

Oxford Nanopore gets cash injection

Biotech company Amgen has announced a £50m (US$66m) equity investment in the UK-based company developing real-time ...

Phillip Godden speaks up about Enzyme Indicator technology

What is the market penetration of the EI technology and why should companies consider the new method for bio- ...

Construction work begins at new WuXi Bio manufacturing plant in China

Located in Shijiazhuang, the manufacturing plant will be equipped with 48,000L bioreactor capacity

Lonza CEO: "We are capitalising on organic growth opportunities"

The business update released by the Swiss CDMO shows double-digit growth with sales in pharma and biotech contributing ...

Expert guide: Single-use supply chain risk management

Industry experts at Avantor describe a supply chain strategy to help drug manufacturers with multiple locations around ...

Vetter further expands secondary packaging due to increasing demand

An additional 2,900sqm will be added to a new building on the Ravensburg site by 2020

Schott eyes new plant in China

German glass specialist inks investment agreement with local authorities to build a pharmaceutical tubing production ...

Barrier systems: taking a safety first approach to processing highly potent pharmaceuticals

To effectively protect humans and products from each other, demand for closed barrier systems such as cRABS and ...

Cleanroom validation: Quality of the product to the front

Cleanroom validation is a multifaceted project, so it is advantageous to have a dedicated project manager to lead, ...

Adequately establishing contamination risk in drug products

Recent changes within the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) put emphasis on risk ...

Cross-contamination risks found at Recipharm UK site

The Swedish CDMO has received a non-GMP compliance warning following inspection at its site in Lancashire

Pathogens in the fire line of electron beam radiation

The Fraunhofer Institute has developed a process for continuous inactivation of pathogen used in the manufacture of ...