Regulatory submissions represent the cornerstone of pharmaceutical product development and commercialization, serving as the formal channel of communication between pharmaceutical companies and regulatory authorities. According to recent industry analyses, the global pharmaceutical regulatory affairs market is valued at USD 9.47
WuXi Biologics has completed its first commercial Process Performance Qualification (PPQ) campaign for three 5,000L single-use bioreactors (SUBs) at its MFG20 facility in Hangzhou, marking a milestone in large-scale biologics manufacturing in Asia. This development makes the MFG20 site the first
“AI doesn’t have to be the first port of call. Many organisations still need to focus on the paper-to-glass journey before they can think about more advanced technologies” – Vishnu Dwadasi Vishnu Dwadasi, Director of Life Sciences at West Monroe,
“Our goal is to be more than a service provider. We aim to be a strategic partner that grows with our clients from bench to bedside.” – Dr. Jim Li Dr. Jim Li, President of CMC Solutions at BioDuro, brings
Chime Biologics, a global CDMO focused on biologics, has announced a strategic cooperation agreement with Polpharma Biologics. The agreement covers the full development and manufacturing cycle of a biosimilar product intended for global markets. Under the partnership, Chime Biologics will
ViroCell Biologics, a specialist viral vector CDMO for cell and gene therapy clinical trials, is supporting a newly launched clinical study at University College London (UCL). The trial, known as CARPALL (cohort 4), is investigating a next-generation CAR T-cell therapy
The Ritedose Corporation, Inc. has announced the installation of a seventh Syntegon packaging line at its advanced manufacturing facility, a move that will double its capacity for individually wrapped vial medications. The new line is expected to be operational by early
Porton Advanced has been appointed the exclusive contract development and manufacturing organisation (CDMO) for Tasly Pharmaceutical Co., Ltd’s dual-targeting CAR-T therapy, P134 Cell Injection. The therapy recently received Investigational New Drug (IND) approval from China’s National Medical Products Administration (Approval No.: 2025LP01030) and
“Managing hundreds of products across multiple species requires a different approach to network strategy than human pharma,” explains Bernhard Boehm, Head of External Manufacturing for Animal Health at Boehringer Ingelheim. Bernhard Boehm leads external manufacturing for animal health as VP
Nikon CeLL innovation Co., Ltd. (NCLi), a subsidiary of Nikon Corporation, has entered into a strategic licensing agreement with RoosterBio, Inc., a US-based stem cell technology company. The agreement aims to provide Japan’s biopharma sector with a comprehensive solution for the
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