This article identifies not only relevant CQAs, but the stage at which their testing may occur and the category of control strategy (e.g. release, stability, etc.). A justification is provided for each CQA category and for each individual attribute. The justifications provide further information, based on industry experience, on whether these CQAs should be considered for products, as there are many different mRNA products, and each company will have their own in-depth understanding and specific characterization information to inform their quality control strategies
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Overview of end-to-end mRNA drug substance and drug product manufacturing processes and scale-up considerations
This paper gives an overview of the mRNA/lipid nanoparticles manufacturing unit operations for drug substance/drug product. It was developed by CGT experts in the RNA workstream of BioPhorum Cell and Gene Therapy to enable future discussions and accelerate the commercialization of mRNA therapies.
This BioPhorum member only questionnaire presents a tool for sponsors to ascertain the suitability of the contract organization services and for the contract organizations to understand the scope, requirements, and timelines of the RNA transfer project.
This conversation with the authors highlights the important challenges within the RNA field that are being addressed by the RNA workstream within BioPhorum Cell & Gene Therapy . The paper introduces this critical area and shows its unique challenges.
This BioPhorum member only publication is intended to provide a guide of unique RNA product aspects that should be discussed during the NPI kick off meeting for an RNA product to enhance the probability of success of a product transfer between sponsor and contract organizations.
While previously only found in academic, pre-clinical and early clinical stages, RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality due to their essential biological role in protein expression and their potential versatility in manufacturing. RNA is in the global spotlight and is being
prioritized due to the COVID-19 pandemic. However, to maintain the current momentum as industry and agencies return to a ‘normal’ cycle of development for a wider range of drugs and therapies, experts in this field need to come together to identify and address challenges unique to the RNA modality. BioPhorum has started this by bringing together industry leaders to identify RNA-focused manufacturing challenges, and is working toward solutions to common challenges and improving current processes. The purpose of this article is to introduce this critical area and to show the unique RNA challenges, not only limited to mRNA therapeutics already identified by the cross-industry team, but also to include how these challenges could potentially negatively impact companies and the RNA industry. It sets out what the team is hoping to achieve via this collaboration, both in terms of outputs and benefits to the industry.