Chemistry, Manufacturing and Controls content
Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
2023-12-01T09:40:00+00:00By Vivek Tomar, Sateesh Babu, Rajendra Kunda, Deepti Jagga, Allison Gillespie, Achuta Raju Samala, Sakshi Singh and Praveen Basavaraja
Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety ...
Diverse and dynamic regulation in the Asia Pacific region
2024-03-06T15:00:00+00:00By Victoria Goff and Harriet Edwards
Starting in Australia, authors David Batka and Kate Burke look at the trends within its market for 2024. Two years ago, the Australian government and its regulatory agency, the Therapeutic Goods Administration (TGA), initiated an expert review of medicine and device regulations to bring about reforms for patient access, flexible ...
Regulatory imperatives in chemistry, manufacturing, and control for biosimilars
2024-03-06T15:00:00+00:00By Rajendra Kunda, Rick Best, Steve LoCastro and Hao Liu
Navigating the regulatory terrain down under: trends in Australia for 2024
2024-03-06T15:00:00+00:00By David Batka and Kate Burke
Australia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the country’s above-average wealth. Factors such as a skilled workforce, high-quality research infrastructure, government incentives and well developed regulatory and health technology ...
Can the Japanese phase I study be waived?
2024-03-06T15:00:00+00:00By Yoshiaki Hattori and Masami Tamura
New guidance: ‘Basic principles for conducting phase I studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan,’ issued in December 2023
RegRapPod − February 2024
2024-02-20T16:51:00+00:00By Alan Booth
Vol.21 #2: In February 2024’s RegRapPod, host Alan Booth talks to Issue Editors Dejan Brkic and Esteban Herrero-Martinez about medtech.
Chemistry, Manufacturing and controls stories
Antibiotics in biopharmaceutical production
2022-06-23T09:46:00+01:00By Satish Muchakayala and Jill Makin
CMC considerations for US biosimilars development
2022-04-18T15:18:00+01:00By Merry Christie, Alexandra Beumer Sassi and Valérie Pimpaneau
A regulatory view on the change management process for medicinal products
2022-04-18T14:53:00+01:00By Julien Douillet
Gene therapy products: regulatory expectations and challenges for industry
2022-04-18T13:20:00+01:00By Francesco Lanucara
Selection and justification of regulatory starting materials
2022-01-26T13:25:00+00:00By Victoria Goff and John Knight