Eurofins holds a wealth of cGMP experience testing RNA based drugs
Jon Kauffman, Ph.D., Vice President Biologics, Eurofins BioPharma Product Testing,
JonKauffman@eurofinsUS.com; Michael J. McDowell, Executive Vice President,
Eurofins BioPharma Product Testing, MichaelMcDowell@eurofinsUS.com
In December 2020, the Food and Drug Administration granted emergency authorisation to the Pfizer/BioNTechand Moderna coronavirus vaccines. This historic research sprint has reduced the typical seven-year vaccine development process to an unprecedented 10 months. As the initial winners in the coronavirus vaccine development race, the Pfizer and Moderna vaccines have one thing in common, they are both mRNA based, resulting in a new focus on RNA drug development technology.
Messenger RNA (mRNA) is a type of oligonucleotide that is critical to the translation of genetic sequence information of DNA into proteins manufactured in the cell. In the case of these new vaccines, this protein is the signature spike protein of the coronavirus. These mRNA products are considered to be their own unique modality. Distinct from traditional small molecule drugs and biologics such as monoclonal antibodies, they have their own unique analytical challenges. At Eurofins BioPharma Product Testing, supporting RNA based drug development candidates is nothing new. Eurofins’ laboratories in Lancaster, PA; San Diego, CA; and Dungarvan, IRE, have supported both mRNA and RNAi development candidates from leading innovators with their broad cGMP testing service portfolio for close to a decade. Some of the methods employed include:
- Characterisation of Exons (5’ Cap) and Poly (A) Tails
(3’End) by Orthoginal Mass Spec - Purity/Impurity of Starting Materials by LC/MS
- Purity/Impurity by Ion Exchange RP-HPLC and CE
- Identity by Reverse Transcription (RT) SangercSequencing
- Total RNA by Spectroscopy
- Potency - Cell Based Bioassays
- Residual Solvents and Metals by GC and ICP
- Residual plasmid DNA by PCR
The approved vaccines are carried into the body by lipid nanoparticles with polyethylene glycol (PEG), adding to their complexity. Therefore, additional analytical methodologies are employed to characterise the lipid and drug product, including, % RNA encapsulation by Ribogreen, Lipids by HPLC-CAD, Particle Size and Dispersity by Light Scattering.
As with any biopharmaceutical product, various other characteristics are typically required to support stability and release testing as described in USP/EP, including pH, osmolality, appearance, particulate matter, sterility, bacterial endotoxin, and bioburden. Finally, drug developers are constantly employing novel delivery systems and formulations to increase the efficacy of their products, so additional assays may be required to provide information to cover these aspects of the final product. Contact us to learn more: www.eurofins.com/BPT-Contact-Us.