Capabilities
Analytics
Data-Driven Development. Built for Viral Vectors.
Analytical development is at the core of successful viral vector and advanced therapy programs. At ReiThera, Analytics is fully integrated with Process Development, GMP Manufacturing, Quality, and Regulatory Affairs to accelerate development and support regulatory success.
Our teams design, optimize, qualify, and transfer analytical methods for product characterization, comparability, stability studies, and GMP manufacturing. Leveraging flexible analytical platforms, established SOPs, and a broad range of methodologies, we rapidly implement tailored testing strategies that reduce timelines, control costs, and support informed development decisions.
Integrated Analytical Development
Our analytical scientists work closely with Process Development and Manufacturing teams to establish robust analytical strategies aligned with product-specific Critical Quality Attributes (CQAs). We support:
Analytical feasibility studies
Method development and optimization
Method transfer
Method qualification and validation
Reference standard and control strategy development
Product characterization programs
Comparability studies
Process characterization support
Regulatory analytical package preparation
This results in a Quality system that is not only compliant but responsive, collaborative, and built around client success.
Product Characterization Expertise
A comprehensive understanding of product quality is essential to support development, release, GMP manufacturing consistency, and regulatory approval.
Our analytical capabilities support characterization of:
Identity
PCR-based identity assays
Restriction fragment analysis
Sequencing and NGS characterization
Transgene confirmation
Protein expression profiling
Potency
Vector genome quantification
Infectious titer assays
Gene expression analysis
ELISA-based assays
Western Blot characterization
Purity and Product Quality Attributes
Vector purity assessment
Residual process-related impurities
Aggregation and particle analysis
Dynamic Light Scattering (DLS)
Product integrity evaluation
Physicochemical Properties
Appearance
pH
Osmolality
Extractable volume
Formulation characterization
Supporting Process Development Through Analytics
Analytics and Process Development operate as a single integrated workflow at ReiThera.
Our analytical teams support:
- Upstream process optimization
- Downstream purification development
- Critical Process Parameter (CPP) evaluation
- Critical Quality Attribute (CQA) assessment
- Scale-up and technology transfer activities
- Process characterization studies
By combining analytical insights with process knowledge, we accelerate process understanding and facilitate efficient transfer into GMP manufacturing.
Stability & Lifecycle Management
Analytical support extends beyond manufacturing readiness and continues throughout product lifecycle management.
Our capabilities include:
- Stability-indicating method development
- ICH-compliant stability protocols
- Long-term stability studies
- Accelerated stability studies
- Freeze-thaw characterization
- In-use stability assessment
- Trending and shelf-life evaluation
These studies provide the data required to support regulatory filings and commercial lifecycle management.
Viral Vector Focused Expertise
ReiThera has extensive experience supporting analytical development programs for:
- Adenoviral vectors
- AAV vectors
- MVA vectors
- HSV-based platforms
- Genetic vaccines
- Gene therapy products
Our platform knowledge allows us to leverage established analytical strategies while tailoring development programs to the specific needs of each product.
Why ReiThera Quality is Different
Unlike traditional testing laboratories, ReiThera integrates analytical development directly within its viral vector development and manufacturing ecosystem.
This enables:
Faster method development and troubleshooting
Strong alignment between analytics and process development
Deep expertise in viral vector characterization
Seamless transition from development to GMP QC testing
Regulatory-ready analytical packages
Efficient support for global clinical programs
The result is an analytical function designed not only to generate data, but to accelerate development, strengthen process understanding, and support successful regulatory outcomes.