The two stories in IPQ’s March/April 2022 issue explore: ● the drivers for and progress in incorporating more third-party auditing of excipient suppliers into user quality management systems, and ● updates from regulator, compendial and industry experts on the CMC challenges of peptides and oligonucleotides.
The two stories in IPQ’s January/February issue explore: ● FDA, industry consortium, and ICH efforts to modernize the way quality information is collected, submitted, and managed, and ● the efforts to strengthen the interface between FDA and industry around manufacturing modernization, with insights from two innovation champions, Janet Woodcock and Jeff Baker.
The two stories in IPQ’s December Monthly Update explore: ● the recent efforts of the USP and European Pharmacopeia to meet the needs of the emerging biotech product modalities and their complex analytical challenges, and ● recent developments in the European GMP arena as its regulator and industry stakeholders work with their counterparts globally to digest and deploy the experience and learnings from the pandemic.
The multipart feature story in this issue focuses on the insights that the leaders of five of the major COVID vaccine efforts have been sharing at recent conferences on: ● how the daunting development, manufacturing, supply chain and regulatory challenges involved in delivering a vaccine at the global level in unprecedented speed during a pandemic were addressed, and ● the lessons that can be garnered from that highly collaborative experience in moving forward.
The feature story in this issue centers on the challenges and developments around raw material control for biological products. A main focus is the discussion that took place at a USP workshop on the raw material issues held in April 2021. The story’s three parts delve into: ● FDA views on where the regulatory concerns and expectations lie across the review and inspection continuum ● how the challenges expand in handling raw materials in the CGT context, and ● where biomanufacturers are in using and controlling polysorbates, in particular.
The feature story in this issue explores the dialogue regulators and industry are having on the key CMC issues that are presenting themselves in the development and review of peptides and oligonucleotides and the approaches and expectations for addressing them. A central focus is the discussion that took place at the USP 2021 peptides/oligonucleotides workshop. The story’s four parts explore: ● recent CMC/regulatory challenges of oligonucleotide drugs ● comparability challenges in crossing over to generics, including insights from recent FDA research ● comparing peptide and oligonucleotide CMC issues, and ● starting material specifications for oligonucleotides.
The four-part IPQ story in this issue explores the current dialogue on the drivers and pathways for a more collaborative, streamlined and globally-minded regulatory approach to medicine/device combination products in Europe and the activity in progress to reach that goal. In focus in the four parts are: ● the EU Pharma Strategy roadmap, comments from industry, and related agency strategies ● culture/structure/process change and global alignment ● HPRA CEO Lorraine Nolan on HPRA and EMA strategy, and ● EMA’s Zaïde Frias and NB/industry perspectives on EU regulatory transformation.
The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them. The two-part feature story in this issue explores how the ICH Q8-12 efforts to evolve the lifecycle regulatory paradigm to be more transparent, internally coherent, knowledge and risk based, continuous improvement and supply friendly, and globally consistent have not yet been realized, and where the deeper solutions to the problems may lie.