Testing Support for COVID-19 Vaccines and Treatments
Eurofins BioPharma Product Testing network of laboratories partners with the world’s most innovative Bio/Pharmaceutical firms to advance timely therapies to patients in need. As the world strives to combat the COVID-19 pandemic, BioPharmaceutical, Government, and non-profit organizations are working diligently to identify new or existing drug modalities that potentially can be used to treat COVID-19 affected populations.
Two of the COVID-19 vaccines currently authorized and recommended, or undergoing large-scale clinical trials in Europe & US, come from licensed technologies (recombinant protein vaccines and vectored vaccines), or completely new technology (RNA vaccines).
Our global sites have supported both mRNA and Adenovirus candidates from leading innovators for many years. Distinct from traditional small molecule drugs and biologics such as monoclonal antibodies, they have their own unique analytical challenges. Eurofins BioPharma Product Testing’s scientific expertise and breadth of testing capabilities places the company at the forefront in supporting clients’ mission to accelerate COVID-19 drug and vaccine development and put an end to this crisis.
Why Choose Eurofins BioPharma Product Testing?
- Our teams have vast experience supporting vaccines, monoclonal antibodies, oligonucleotides, cell & gene therapy products, therapeutic proteins and conjugates.
- Our global network of 39 GMP laboratories ensures large capacity, including expanded BSL2 laboratory space, to handle any size project.
- We have three service models to choose from to best serve your needs: Fee-For-Service, Full-Time-Equivalency, PSS Insourcing Solutions®
Testing Services Offered:
In the race to deliver life-saving therapies and safe medical devices to patients and medical staff, Eurofins BioPharma Product Testing is providing clients with trusted and expedited COVID-19 testing support for all modalities and parts of the supply chain, including Antivirals, Vaccines, mAbs, Antibodies, RNA, and Testing Kits, with expertise in:
Vector vaccines
Years of experience allow our labs to be able to test all the quality attributes of vector vaccines. These are the tests being routinely handled at Eurofins BioPharma Product Testing in a GMP environment:
- Virus identity by ID-PCR
- Virus protein fingerprinting by RP-HPLC
- Residuals by qPCR and ELISA methodologies
- Transgene expression by cell based-ELISA
- Infectious units and virus particles by cell-based PCR
- Particle concentration by UV-spectroscopy
- and safety tests such as Sterility and Endotoxin
mRNA based vaccines:
At Eurofins BioPharma Product Testing network of laboratories, supporting RNA based drug development candidates is nothing new. Our laboratories 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:
- Characterization of Exons (5’ Cap) and Poly (A) Tails(3’End) by Orthogonal Mass Spec
- Purity/Impurity of Starting Materials by LC/MS
- Purity/Impurity by Ion Exchange RP-HPLC and CE
- Identity by Reverse Transcription (RT) Sanger Sequencing
- Total RNA by Spectroscopy
- Potency - Cell Based Bioassays
- Residual Solvents and Metals by GC and ICP
- Residual plasmid DNA by PCR
Lipid Nanoparticles (LNP)
Two of the approved COVID-19 vaccines are carried into the body by lipid nanoparticles with polyethylene glycol (PEG), adding to their complexity. Therefore, additional analytical methodologies are employed to characterize the lipid and drug product, including:
- % RNA encapsulation by Ribogreen
- Lipids by HPLC-CAD
- Particle Size and Dispersity by Light Scattering.
Additional Analyses
As with any biopharmaceutical product, various other characteristics are typically required to support drug development Eurofins BioPharma Product Testing network of labs have expertise in:
- Raw Materials Testing
- Product Testing
- Viral Testing
- Microbiology
- Cell Banking
- Cell and Molecular Testing
- Stability and Release Testing and Method Development
- Medical Device Testing and Method Development
Backed by decades of scientific experience, vast range of capabilities, and driven work ethic, Eurofins BioPharma Product Testing stands together with clients in working non-stop to provide COVID-19 testing support wherever needed as we all strive to make the world healthier and safer.
For more information about COVID-19 testing support or to request a quote, please contact us.
Discover Eurofins Scientific’s global COVID-19 testing support initiatives: https://www.eurofins.com/covid-19-response/
