Sanner Group Opens Second Manufacturing Facility in China

The Sanner Group, a global provider of healthcare packaging and medical device components, is expanding production capacity in the Asia-Pacific region, bringing a new manufacturing facility on stream in Kunshan, China. Kunshan II will operate alongside Sanner’s existing manufacturing facility, increasing flexibility and boosting production capacity by 80%. A key element of the company’s broader […]

For Facility Assessments, FDA Recommends Alternative Tools

The US FDA has gone on to release a draft guidance that outlines its approach to utilising alternative methods so as to evaluate drug manufacturing facilities that are included in pending marketing applications. For instance, the applications include new drug applications, abbreviated new drug applications, as well as biologic licence applications. This approach will primarily […]

Swedish Stakeholders Seek Alterations In EU Pharma Reforms

The Swedish government this summer has gone on to provide an opportunity for more than 120 stakeholders so as to share their viewpoints on the new EU pharmaceutical package that was put forward by the European Commission in April 2023. More than 70 individuals have gone on to send their comments to the government. The […]

Vetter looks ahead to further expansions to meet supply chain demand

Committed to sustainable growth and long-term planning Dedicated to making investments to support increased customer demand Maintain efficiency and quality in development and manufacturing processes Ravensburg, Germany, October 17, 2023: Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), announces additional investments as part of its long-term dedication to customer partnerships. Vetter’s extensive 40+ […]

Cellares Announces Expanded Agreement with BMS to Include Second CAR-T Program in Cellares Technology Adoption Partnership Program

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, announced that global biopharmaceutical company and cell therapy leader Bristol Myers Squibb  will enter a second proof-of-concept tech transfer process for the manufacture of a CAR-T cell therapy, as part of the Cellares Technology Adoption Partnership (TAP) program. […]

Gritgen Therapeutics Launches Commercial GMP Facility in China

Gritgen Therapeutics Co., a biotechnology company focused on gene therapy products, reported the successful validation and launch of operations at its commercial GMP facility in Suzhou China for the production of Gritgen’s phase III clinical and commercial product for hemophilia A. The construction of Gritgen’s GMP facility adheres to the global cGMP standards and complies […]

Cellipont and Diakonos to develop cell therapy for glioblastoma

Cellipont Bioservices has signed an agreement with Diakonos Oncology for the development of DOC1021, a cell therapy to treat glioblastoma multiforme (GBM). The parties will carry out the process development and current good manufacturing practice (cGMP) production of DOC1021 for GBM and other cancers. Diakonos CEO Mike Wicks stated: “As DOC1021 is personalised to each […]

Sygnature Discovery collaborates with Axol Bioscience to utilize human iPSC-derived microglial cells in high-content imaging drug discovery screening workflows

Sygnature Discovery, a world-leading integrated drug discovery provider and non-clinical solutions provider, has announced a scientific collaboration with human induced pluripotent stem cell (iPSC) experts, Axol Bioscience. The collaboration aims to explore the incorporation of human iPSC-derived microglia into high-content imaging in vitro screening workflows. Human iPSC-derived cells are stem cells derived from patient donors […]

Elsevier launches new PharmaPendium, empowering pharma companies to bring novel drugs to market faster and increase success of regulatory submissions

Elsevier, a global leader in information and data analytics, has launched the new PharmaPendium, sharpening the translational view of a platform that combines extensive preclinical and clinical data, including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages, with predictive tools to accelerate drug development. PharmaPendium enables companies to make faster, more […]

Phastar Net-Zero Target Approved by the Science Based Targets Initiative

Phastar, a global specialist biometrics contract research organization (CRO), has had its net-zero target approved by the Science Based Targets initiative (SBTi). The SBTi is a global body enabling businesses to set ambitious emissions reductions targets in line with the latest climate science and is considered the gold standard for net-zero. A core component of […]