Development

Articles

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

ADC Bio Secures Additional Equity Round Investment

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Demand for highly potent APIs continues to rise.

Building Capacity for Potent API Production

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy. 

Cambrex Development Center in North Carolina Focuses on Continuous Flow

Clovis Oncology and Lonza celebrated the grand opening of a dedicated production train at Lonza’s Visp, Switzerland site for manufacturing Rubraca (rucaparib).

Lonza Opens Monoplant for Clovis Oncology’s Rubraca

Integration of new modeling and analytical tools with flow chemistry are notable trends.  

Efficiency Demands Drive Advances in API Labs

Agnes Shanley is senior editor of Pharmaceutical Technology.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

After Valsartan Recalls, Regulators Grapple with Nitrosamine Contamination in APIs

The $425-million acquisition adds formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.

Cambrex Completes Acquisition of Halo Pharma

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

FDA Expands NDMA Investigation to All ARB Class Drugs

Existing software tools cannot take into account the complexity of disease.

Can Artificial Intelligence Take the Next Step for Drug Repositioning?

Low-temperature chemistry enables performance of more challenging and selective chemistry.

API Synthesis and Manufacturing, Small Molecule