Over the past few years, frustrating instances of shortages and recalls – particularly generics – have been blamed on inferior quality control at countless suppliers of active pharmaceutical ingredients and finished products, especially those based in India and China.

Given the transformative nature of regenerative medicines, treatments yielding greatly improved patient responses that now exist as viable products on the market, cell and gene drug developers over the past several years have been drawing deal attention. Not only through collaborative partnerships, but also as acquisition targets.

As more regenerative medicine products approach clinical testing and commercialization, stakeholders in the field are increasingly pressed to address substantial challenges, including pricing and reimbursement, GMP manufacturing, and clinical availability, and patient accessibility to these life changing therapies.