The advancing CMC innovation support programs at EMA and FDA are highly complementary in focus and structure, with distributed and continuous manufacturing drawing significant up-front attention at both agencies. The four-part story featured in IPQ’s September/October Monthly Update explores the significant effort underway to deepen the regulator/industry/academia communication needed to realize the potential for technological advancement in the manufacturing and control arena, and in CM and DM in particular.
Regulator and industry understanding and implementation of quality risk management in drug manufacturing and control has been advancing and ICH has revised its QRM guideline Q9 accordingly. The four-part story featured in IPQ’s July/August Monthly Update includes insights from the rapporteur and other Expert Working Group members involved in drafting the revisions – as well as from other QRM experts – on the issues addressed and the implementation expectations and challenges. Parts III and IV of the story home in on two of the areas drawing attention in Q9(R1) – risk-based decision-making and product availability risks, respectively.
The first of the two interrelated stories featured in our May/June Monthly Update focuses on titanium dioxide (TiO2) as a good case study of the layers of challenges that come into play as food, chemical, and environmental concerns get translated into the medicines arena. The second five-part story delves more broadly into the challenges of designing and implementing constructive and viable environmental policies that do not carry with them unintended consequences for medicines. The parts explore: ● the need for pharma stakeholder engagement ● EU PFAS action and pharma mitigation needs ● F-gases and hydrofluorocarbons in inhalation products ● a DIA Europe legislative session panel discussion, and ● the TiO2/nanoparticle dialogue at a June PQRI workshop.
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.