The East Syracuse site will serve as the LOTTE Centre for North America Operations for LOTTE’s new biologics contract development and manufacturing organisation (CDMO) business in the United States.
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Learn the benefits of collaboration between the pharmaceutical scientists and clinical supply services teams.
12 May 2022 | By Bruker
In this webinar, experts will discuss state of the art technology to characterise polysaccharide vaccines and relative implementation in biopharma development and manufacturing.
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
Novartis has suspended production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey as it addresses potential quality issues identified in its manufacturing processes.
Winners of ISPE's Facility of the Year Awards (FOYA) 2022 include Janssen, Takeda, CRISPR Therapeutics, Catalent and Iovance Biotherapeutics.
Following a successful pilot in 2021, Sanofi and McLaren Racing have decided to extend their collaboration across multiple sites in seven countries, covering more than 100 production lines, across all technologies.
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
Reducing downtime: acoustic emission testing of compressed air pressure vessels in pharmaceutical production
Leakage, cracking and corrosion in pressure vessels present a serious risk for operators of pharmaceutical production systems. Imminent damage must be reliably identified at an early stage to enable necessary steps to be promptly taken. Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, explains how TÜV SÜD…
The facility is designed around a central unit that comprises several fully digitalised modules, which can produce up to four vaccines simultaneously, regardless of the vaccine technology used.
The scale up in annual capacity and expansion of Achilles' global clinical manufacturing footprint will see its second site in the UK and first site to be established in the US.
Novel and advanced therapies have come on in leaps and bounds over the past decade. Some cell and gene therapies have already reached the approvals stage, while others have now entered the later development stages. As a result, manufacturing process consistency, GMP standards and more must now meet more formal…
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.