uBriGene Biosciences (uBriGene), cell and gene therapy CDMO has announced the submission of a Drug Master File (DMF) for its iPSC Reprogramming mRNA-LNP Kit. The regulatory filing outlines the product’s manufacturing processes, characterization, and compliance with quality standards. The iPSC Reprogramming
Boehringer Ingelheim BioXcellence™ has secured approval to participate in China’s segmented manufacturing reform, a regulatory initiative led by the National Medical Products Administration (NMPA). This programme aims to enhance efficiency and flexibility in the production of biological products. With this qualification,
“Seven out of ten medicines dispensed in Europe are generic products. When we only look at price, we don’t take into consideration all the efforts European companies make on sustainability. This is an industry we must protect,” says Elisabeth Stampa,
Lonza Capsules & Health Ingredients has announced the establishment of a Center of Applied Sustainability, aiming to integrate sustainability into product development and reduce its environmental footprint. The initiative aligns with Lonza’s near-term science-based emissions reduction targets, validated by the Science
The Ritedose Corporation has announced “1,000 Hours of Purpose,” a year-long initiative allowing employees to volunteer their time and skills to support local charities. The program, launched in collaboration with United Way of the Midlands, will see Ritedose employees contribute 1,000
Amaran Biotechnology Inc., a subsidiary of OBI Pharma specializing in CDMO services, has signed a Memorandum of Understanding (MOU) with Japan-based Nippon Fine Chemical Co., Ltd. and its Taiwan subsidiary, Zillion Fine Chemicals International Co., Ltd. The collaboration aims to advance nanoparticle-based drug contract
Adragos Pharma has completed a €4 million investment at its Leipzig, Germany facility, significantly increasing its liquid filling capabilities. The project involved the installation of a cGMP-compliant liquid filling line and a cartoning machine, boosting production capacity nearly tenfold. The newly
Eli Lilly has announced plans to invest $27 billion in four new U.S. manufacturing facilities, marking the largest pharmaceutical expansion investment in the country’s history. The Indianapolis-based company revealed the initiative during a press conference in Washington, D.C., under the banner
Pfizer is prepared to adapt if pharmaceutical tariffs are introduced under a second Trump administration, CEO Albert Bourla, Ph.D., said at TD Cowen’s 45th annual healthcare conference in Boston. The company already operates 13 manufacturing sites across the U.S. and could
ProBioGen and Marea Therapeutics, Inc., a clinical-stage biotechnology company developing novel medicines for cardioendocrine diseases, have announced the successful completion of a sprint project to supply clinical material for MAR002. The investigational anti-growth hormone receptor (GHR) antibody is being developed for the
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