Comprehensive Analytical Services for RNA and Virus-Based Therapeutics
From discovery through GMP production, we provide robust analytical services tailored to the needs of your clinical trial candidate.
Our capabilities
Our optimized processes ensure accurate enzyme and DNA concentrations, reducing impurities such as dsRNA and minimizing the need for custom analytics—leading to faster development timelines.
We offer a comprehensive analytical toolkit designed for routine analysis and method validation, while also being fully equipped for custom analytical services based on specific project needs.
At Exothera, we specialize in RNA and viral vector analytics, supporting discovery, preclinical, and clinical development as well as GMP manufacturing quality control. Our analytical services are available as part of development and manufacturing projects, or as standalone services.
Our Analytical Services Cover
RNA (mRNA, pDNA, LNPs)
AAV Analytics
Adenovirus Analytics
We provide expert guidance and execution across method development, routine analysis, and GMP-quality control testing for these platforms.
RNA Analytical Capabilities
- pH, Endotoxin, Bioburden, Appearance: Compendial
- Residual DNA template: ddPCR
- Residual total protein: uBCA
- DNA concentration & purity: Nanodrop
- Residual unincorporated nucleotides: HPLC
- Linearization profile: Gel electro
- mRNA sequencing & Poly a tail: Nanopore
- mRNA integrity: Capillary electro
- % of linearized DNA: Capillary electro
- Identity by size: Starting mat.
- Capping efficiency: UPLC
- dsRNA: ELISA
AAV Analytical Capabilities
We provide end-to-end in-house analytics for AAV, with select specialized assays outsourced to trusted partners. Our expertise ensures that your product meets regulatory and quality standards for release and characterization.
In-house release testing
- Safety :
- Bioburden
- Endotoxins
- Appearance :
- Clarity & opalescence
- Color
- Other :
- pH
- Osmolality
- Cell viability
- Identity :
- Vector capsid identity
- Capsid proteins identity
- Purity :
- Total residual plasmid DNA
- Residual endonuclease
- Total residual host cell DNA (HCD)
- Residual host cell protein (HCP)
- Protein purity (capsid protein ratio)
- Vector aggregates
- % Full particles
- % Empty particle
- Capsid proteins purity
- Encapsidated HCD
- Encapsidated plasmid DNA
- Encapsidated E1 gene
- Residual total E1 gene
- Residual affinity ligand
- Residual HCD sizing
- Quantity / Potency :
- Physical viral titer (Vector genome titer)
- Physical viral titer (Viral particle)
- Infectious viral titer
- Ratio of full to empty particle
- Potency
In-house characterization testing
- Identity :
- Capsid proteins identity
- Purity :
- Capsid proteins purity
- Encapsidated HCD
- Encapsidated plasmid DNA
- Encapsidated E1 gene
- Residual total E1 gene
- Residual affinity ligand
- Residual HCD sizing
Adenovirus Analytical Capabilities
We offer extensive in-house analytical services for adenovirus, complemented by outsourced specialized assays. Most assays are performed in-house, ensuring full analytical support from development to release. Our experience in adeno analytics enables us to assist clients from start to finish, covering method development, validation, and GMP release testing.
In-house release testing:
- Safety
- Bioburden
- Endotoxins
- Appearance
- Clarity & opalescence
- Color
- Other
- pH
- Osmolality
- Cell viability
- Purity
- Residual endonuclease
- Total residual host cell DNA (HCD)
- Residual host cell protein (HCP)
- Vector aggregates
- Process-related impurities: BSA (if any)
- Quantity / Potency
- Physical titer (Genome titer)
- Infectious titer
- Ratio of physical titer / infectious titer
- Potency (gene/protein expression)
Why Choose Exothera?
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End-to-End Analytical Support → From method development to GMP release testing
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Expertise Across Platforms → Supporting RNA, AAV, and Adenovirus
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Regulatory Compliance → Aligning with GMP and regulatory standards
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In-House Capabilities & Trusted Outsourcing → Covering all key assays
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Flexible & Customizable → Tailored analytical services for your project
For any additional information,
please contact us—our team will respond quickly!