Developing standards in a fast-moving arena like biotechnology is a challenging task. The four-part feature story in IPQ’s Monthly Update for March and April explores what USP has been able to achieve and where it is looking to expand its contribution, in collaboration with industry, government and academic stakeholders, through a “solutions-based” approach that focuses on the development of standards addressing assay and process performance. Also shared is what CBER reviewers are seeing and advising in reviewing CGT CMC applications – in particular, regarding the challenges of potency testing for CAR T cell therapies.
The story featured in IPQ’s January/February Monthly Update explores how the US government is continuing to strengthen its collaborative efforts with industry and academia to de-risk and accelerate manufacturing innovation as the learnings from the pandemic get further digested. The five-part story provides a wealth of insights from key leaders and policy makers on the innovation issues at play and how the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and other organizations are seeking to address them in the US and internationally.
The story featured in IPQ’s December 2022 issue focuses on the issues that have arisen and the progress that has been made in implementing the risk-based assessment strategy for elemental impurities (EIs) provided in ICH Q3D. The four parts of the story address: ● the role of a watershed workshop cosponsored by the Product Quality Research Institute (PQRI) and FDA ● the perspectives and experience of US and European regulators ● USP and Ph. Eur. harmonization with ICH Q3D, and ● the outcomes of a PQRI study on variability in EI analysis.
The experience of the pandemic has underscored the criticality of assuring that regulatory processes keep pace with innovation in the manufacturing and control arena and has spurred the efforts that were underway in Europe to assess the issues involved and implement the adaptations needed to address them. The three parts of the IPQ story featured in IPQ’s October 2022 issue address the progress of these efforts.
The story featured in IPQ’s October 2022 issue focuses on how EMA’s toolbox on CMC flexibilities has been evolving to incorporate industry input and learnings from the pandemic. The three parts of the story center around the discussions that took place at a session of the October 2022 CASSS CMC Strategy Forum at which regulator and industry leaders shared their experiences and learnings in applying flexibility tools from a regional and global perspective.
The two stories featured in IPQ’s August/September 2022 issue explore: ● the dialogue now going on among regulators, pharmacopeias, and industry on the challenges associated with the manufacturing, characterization, and QC of nanoparticle-based formulations, and ● how CBER’S Advanced Technologies Program (ATP) is being strengthened through the expansion of internal and external funding, scientific and regulatory expertise, and CBER Advanced Technologies Team (CATT) collaboration, and the recent experience of CDER’s Emerging Technology Team (ETT).
The four-part story featured in IPQ’s June/July Monthly Update explores how an FDA-commissioned study carried out though the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator dialogue and agenda on advancing innovation in pharmaceutical manufacturing. With a workshop held on the study report as a central point of reference, the four parts cover: ● the study’s focus, aim, process, organizations involved, and recommendations ● the mechanisms that are now in place to enable innovation ● the challenges and opportunities that are presenting themselves, and ● the path forward. Included are updates on related developments and discussions since the workshop was held.
The three-part story featured in IPQ’s May Monthly Update explores how the pandemic and longer-term trends are converging to spur pharma innovation, collaboration, and operations modernization. In focus in the three parts are: ● insights on these trends from key thought leaders ● the coordination role the US government is playing in addressing the pandemic and other health crises, and ● how the Gates Foundation is helping support the development of new technologies for improving vaccine access in low- and middle-income countries (LMICs).