Tag: Supply chain

Axplora announced the completion of its first research and development batches of exatecan, a camptothecin-class topoisomerase I inhibitor, to establish an additional European source for antibody-drug conjugate (ADC) developers [1]. The company said exatecan development and manufacture are based at its Farmabios site in Gropello Cairoli, Italy, and linked to payload-linker development and bioconjugation operations at its Novasep CDMO site in Le Mans, France [1]. Validation batches are targeted before the end of 2026, with initial GMP supply targeted for late 2027 [1].

Transitioning from lab manufacture to commercialization presents significant challenges, no matter what area you’re working in. Cell and gene therapies are no different and production quantities must scale at multiple stages, first to support clinical trials and then when they reach the market.

Timing is everything. Just over a decade ago, the pharmaceutical industry and R&D in China was dominated by generics and plagued with insufficient technical capacity...

Over the past decades novel drugs for the treatment of human disease have become more complex. According to the Global Business Reports and CPhI joint Industry Explorations...

Ahead of CPhI Worldwide 2015, CPhI expert panelist, Vivek Sharma, CEO of Pharma Solutions at Piramal, analyses the challenges in developing and manufacturing of...