Contract development and manufacturing organization (CDMO) Samsung Biologics made a splash at the end of 2025, acquiring ...

Figure 1A: Antibody–drug conjugate (ADC) structure and delivery pathways; linker chemistry determines the mechanism by which cytotoxin release occurs. This schematic shows a monoclonal antibody (MAb) ...

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 ...

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 ...

The 2011 process validation (PV) guidance document from the US Food and Drug Administration (FDA) states that the number of samples used for PV “should be adequate to provide sufficient statistical ...

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, ...

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 ...

The concept of an analytical lifecycle has been well received in the biopharmaceutical industry. In 2016, the US Pharmacopeia (USP) advocated for lifecycle management of analytical procedures (1) and ...

Demand for biopharmaceuticals is growing rapidly as new products and manufacturing technologies arise. For example, such approaches as immunooncotherapy and oncolytic viral therapy are now entering ...

Biologics such as monoclonal antibodies (mAbs), other recombinant proteins, and viral vectors now represent a major class of pharmaceuticals. Their manufacturing, based primarily on mammalian-cell ...

Much has changed since large-scale single-use biomanufacturing equipment was introduced some 15 years ago. Since then, these materials have become accepted and established in production and downstream ...

For comments about how contract development and manufacturing organizations (CDMOs) manage their cell-banking quality assurance (QA) practices. I contacted long-time member of BPI’s Editorial Advisory ...