The first story provides thought-provoking insights from Jeff Galvin, the CEO of California-based American Gene Technologies (AGT), on the implications of the design-based development paradigm and therapeutic power that comes into play for cell and gene therapies. The multipart story that follows takes our readers inside FDA’s efforts to adapt its CMC regulatory processes and expectations to the CGT needs. Addressed are the various ways in which CBER has been seeking to fulfill the two complementary sides of FDA’s mission in the CGT arena – protecting the public from unapproved and potentially dangerous products, and striving to create a regulatory framework and approach that is as supportive as possible for advancing the field.
In this issue, IPQ explores the dialogue on how the CMC/quality regulatory expectations, guidance and standards can keep pace with and best support the expanding therapeutic potential of peptides and oligonucleotides. The second story focuses on the discussion at USP’s five-year meeting in May by its leadership of the key challenges that the world faces in assuring the supply of quality medicines and the role that USP can play in addressing the challenges through its standards setting, advocacy, and capability building efforts.
The need for intensive collaboration to address the complex challenges of assuring the quality and availability of the world’s medicines has only deepened in the face of the global pandemic we are now facing, as the two stories in our review of April and May make clear. ● The first story is a five-part exploration of the collaborative efforts now going on globally to advance in vitro testing in assessing and controlling adventitious viruses for vaccines and biotherapeutics – and to unleash the potential of next-gen sequencing in particular. ● The second story explores how the National Institute for Innovation in Manufacturing Biopharmaceuticals has been evolving and some of the challenges now drawing the attention of the public/private partnership.
The first story in the March Monthly Update explores recent FDA global field inspection and enforcement operations. In focus are: ● the impact of the pandemic ● the field office’s API and drug product inventory and enforcement tools ● recent warning letter and import alert data and trends, and ● progress on the goals of reducing the timelines for inspection classification/notification and warning letter issuance. The following story provides insights from FDA’s drug compliance management on the recent global developments and trends of significance across the API, OTC, sterile product, compounding, and supply chain arenas.
In this issue, IPQ explores the need for excipients that are fit-for-purpose in meeting the complex challenges of formulating, manufacturing, and delivering the new generation of medicines and making them as safe, efficacious, and patient- and distribution-friendly as possible. The five parts of the story focus on: ● a novel excipient review proposal from FDA and stakeholder comments ● industry thought leaders on the novel excipient drivers ● the issues involving subcutaneous biotherapeutics, pediatrics, and delayed release ● USP initiatives supporting novel excipient development, and ● assessing and managing excipient risks.
The December issue explores the collaborative efforts in which industry and regulators are now engaged to address the challenges of assuring the quality and availability of medicines across an increasingly globalized supply chain. The first story reviews various components of the progress that is being made in inspection-related information, standards and resource sharing – with a focus on the US and Europe, in particular – while the second shifts the focus to the Southeast Asia regional efforts going on through ASEAN.
In this issue, IPQ explores the prominent FDA and industry association initiatives that are active in the quality metrics and culture arena – how they are progressing, how they interrelate, their impact, and the learnings they are providing. The first story focuses on the initiatives taking place on the pharma side, while the second shifts to the implementation of the Center for Devices’ highly relevant Case for Quality and voluntary improvement pilot programs.
The issue begins with an exploration of how USP is evolving its standard setting approach for the new generation of biologic products and processes, and follows with a complementary review of the challenges in raw material and excipient use in biologics, in particular. The next two stories focus on the regulator and industry learnings, respectively, in gaining experience with the unique considerations that cell and gene therapies present in facility and operation management.