Cell-line development enhances biopharmaceutical production capacity and quality, but complex biologics like bsAbs and ADCs present new challenges.

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.

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

But before we say goodbye to 2025, we leave you with five of our favorite features from this year, delving deeper into a few of the topics we’ve addressed here. These stories speak to the state of the ...

BPI contributor Justin Byers is cofounder and chief executive officer of Axio BioPharma.

Ion-exchange chromatography (IEC) is a common method for oligonucleotide purification (1, 2). Separation by IEC often uses strong–anion-exchange (AEX) resins at moderate to strongly basic pH values. A ...

A digital twin (DT) is a theoretical representation or virtual simulation of an object or system composed of a computer model and real-time data (1). A DT model operates upon information received from ...

Ionizing-technology–based industries are growing rapidly around the world. The expansion is driven mostly by the technology’s myriad applications, including polymer crosslinking, medical device ...

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 is at the forefront of technological advancements, with “biopharma 4.0” revolutionizing the way biomanufacturing is conducted (1). The concept combines automation, ...

Figure 1: Typical sequence of pharmaceutical-manufacturing and equipment-cleaning operations in multiproduct equipment; the red and green bars represent batches of previously and subsequently ...