Authors explore complexities in scaling gene-therapy production with special attention is to monitoring and enhancing ...

Biotechnology company Leucid Bio announced a strategic collaboration with Syenex, an open-source gene therapy platform firm. Leucid will gain access to Syenex’s VivoCell Platform for in vivo delivery ...

The company is struggling to make ends meet as it loses a major undisclosed client.

Vaccine maker Moderna has announced a $140 million US manufacturing expansion at its existing Moderna Technology Center (MTC) in Norwood, Massachusetts. The project is envisioned to strengthen the ...

Process intensification is reshaping antibody manufacturing and driving increased productivity, flexibility, and sustainability across bioprocessing. This special report, developed in collaboration ...

Although processes and technologies for manufacturing autologous cell therapies continue to improve, problems with scalability and supply-chain complexity remain the modality’s largest limiting ...

Regulatory agencies increasingly are adopting risk-based inspection strategies to ensure that biological products meet stringent safety, efficacy, and quality standards. US Food and Drug ...

The biopharmaceutical industry generally recognizes allogeneic cell therapy’s theoretical advantages over autologous approaches. Although autologous therapies entail one batch per patient, ...

The International Society for Pharmaceutical Engineering (ISPE) has released its ISPE GAMP Guide: Artificial Intelligence. The guide is designed to be compatible with existing frameworks, including ...

Last month, Swiss biopharma giant Roche announced plans to invest $50 billion across its US network, both in pharmaceutical and diagnostics R&D and manufacturing. Among the projects, the firm laid out ...

AntiD (trinbelimab, BSV Bioscience) prefilled syringe with safety device. Prefilled syringes (PFSs) are an optimal method of delivering biologics because they provide for easy administration, decrease ...

In an interview with the BBC, Eli Lilly CEO David Ricks said that strict controls on drug prices may protect customers from paying more for medicine, but suppliers and shareholders could end up ...