NEWS

Identifying Critical Quality Attributes for mRNA/LNP

31 July 2023
Advanced Therapy Medicinal Products
Christine Boswell
Global Change Facilitator

Ensuring consistent high-quality mRNA drug product manufacturing under continually compressed timelines is a significant challenge for developers. Within this environment, the early identification of critical quality attributes (CQAs) reduces the risk of product development delays and ensures alignment of product quality testing and control with regulatory agency expectations.

However, mRNA is still a new modality with increasing knowledge and developing global regulatory guidelines, and there is still little precedent in terms of marketed products and regulatory approvals to help guide developers through the challenges associated with manufacturing and establishing quality control strategies. This situation could adversely impact control strategies and timelines and, in turn, increase the cost of batch product.

To help alleviate some of these issues, industry needs a resource of potential CQAs for products from the early stages of drug development to commercial manufacturing, enabling quick identification of relevant CQAs. This is why we have published Defining the Required Critical Quality Attributes (CQAs) and Phase Requirements for mRNA/LNP Product Development and Manufacture.

The paper includes a comprehensive list of the CQAs for mRNA/lipid nanoparticles (LNP), including the importance of testing at different stages of drug substance and product manufacture. A justification of the importance of each CQA is provided along with further information on whether these CQAs should be considered for a product – as there are many different mRNA products, each company will have its own in-depth understanding and specific characterization information to inform their specific quality control strategies.

“This paper represents the collective thinking of a broad spectrum of industry SMEs and leaders in the relatively new and extremely promising field of mRNA/LNP-based therapeutics,” said Steven Wolk, Vice President, Chemistry & Boulder Site Head, at Editas Medicine. “This work represents an initial effort to establish an industry standard for mRNA/LNP analytics that can be continuously improved through cooperation with the agencies, academia, and industry.”

It is important to note that various product quality attributes will be deemed critical based on regulatory guidance. So, the application of some or all of the CQAs must be assessed by the respective manufacturer in conjunction with the relevant regulator/authority. The CQAs in our paper may be considered potential CQAs, non-critical quality attributes or CQAs depending upon your individual product, process knowledge and legislative requirements.

We hope you find this paper a helpful reference while regulators continue to further develop and expand their guidelines. Considering these questions early on in the development of commercial manufacturing processes might also prompt you to consider measuring new CQAs or justify not including some CQAs to support efficient and appropriate quality control strategies.

For more information, download the paper here and contact Christine Boswell, Global Change Facilitator, at christine.boswell@biophorum.com

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Addressing the challenges of using RNA as a therapeutic or a gene-editing tool

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

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Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

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Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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