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Analytical Method Release and Stability Platform for RNA Drug Substance

As a leader in cell and gene therapy (CGT) manufacturing and testing for 25 years, Aldevron has built superior analytical capabilities and expertise to support characterisation, release, and stability testing of internally manufactured products. Aldevron has evolved with this growing industry and expanding regulatory landscape. In addition to this internal knowledge growth, Aldevron has made strategic hires to further enhance its analytical knowledge base. Aldevron uses a life cycle approach to analytical method development and validation as outlined in several recent guidance documents, including USP <1220>, ICH Q2 , and ICH Q14.

Offering analytical testing at the same site as manufacturing provides a key strategic asset supporting the contract development and manufacturing organization (CDMO), helping fill an extensive and growing analytical testing shortage in the CGT industry. Our integrated manufacturing and testing services provide quality and speed – robust and unique advantages for our clients.

Aldevron offers comprehensive analytical support in the Research & Development space to aid the development of commercial products. This end-to-end support includes:

  • Method development
  • Method validation and transfer
  • Process characterisation testing
  • In-process testing
  • Process validation testing
  • GMP release testing in a QC (Quality Control) environment

Aldevron’s Quality Control laboratory offers a high level of compliance. As a fully GMP laboratory, clients can be assured that testing is performed under the highest level of good documentation practices, analyst training, instrument qualification and software validation. ALCOA+ principles are applied across the analytical space, especially for method validations, stability, and release testing. Data integrity is assured through document control, archiving, and audit trail review.

With Aldevron now part of the Danaher group of companies, the opportunities to optimise and advance our analytical capabilities are enhanced through close working relationships with industry leaders such as Precision NanoSystems Inc. (PNI), IDT, SCIEX, Molecular Devices, and Beckman Coulter. These collaborative relationships further expand Aldevron’s expertise and scope of services and technologies that includes next generation plasmids, such as Nanoplasmids and RNA backbones, process development and manufacturing, and in vitro transcription and gene editing enzymes for gene and cell therapies. This unity under one roof provides solutions and support for our customers to meet their specific needs. Putting the client first, Aldevron is positioned to assist through the full process of end-to-end manufacturing that improves the customer journey from the clinical trial phase all the way through to commercialisation.

Analytical Characterisation for Drug Substance

The mRNA drug substance process utilises enzymatic reactions that include different 5′-cap structures (i.e., Cap0 vs Cap1), variable 3′-poly(A) tail length, and truncated mRNA transcripts. This can produce a mixture of product variants and other notable impurities that include double-stranded RNA (dsRNA) molecules and residual plasmid DNA templates. Despite purification steps to remove these unwanted byproducts, the risk of carrying a small portion of impurities remains. Therefore, such product quality attributes should be characterised during in-process and lot release testing of the purified mRNA.