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Sophisticated Analytical Solutions

Cell & Gene Therapies

Services_Characterization

 

Characterization

Extensive expertise in CGT characterization, including raw material testing, cell culture media-specific analysis, and oligonucleotide analytics and vector characterization, all in a regulated cGMP environment.

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Services_Cell Line Genetic Stability

 

Genetic QC

Our proprietary Target Locus Amplification (TLA) technology accurately determines gene editing outcomes, supporting our QC solutions for cell lines, viral vectors, genetically engineered models, and ATMPs.

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Services_Impurity

 

Impurities

With comprehensive capabilities for impurity testing and contamination control, we have solutions from initial profiling to commercial control across modalities and dosage forms.

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Services_GMP Drug Substance

 

Release Testing

A complete suite of identity, purity, potency, and safety tests including physical, chemical, cellular, and functional QC testing. With expertise in bioassay potency testing and cGMP compliant analytical ultra centrifugation (AUC) for vector payload analysis.

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Services_Stability Studies

 

Stability

We offer stability studies for every clinical phase. Capabilities include forced degradation, photo stability, freeze-thaw testing, and a range of temperature and humidity options.
>80 m on-site storage.

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Services_Biosafety Testing

 

Biosafety

Sterile and non-sterile product testing including rapid methods, organism identification, pyrogen & endotoxin testing, and container closure integrity testing (CCIT).


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Meet Every Challenge in Cell & Gene Therapies with a

Solvias Solution

The Challenge

The development of novel therapeutics often requires testing methods designed and optimized to address novel therapeutic attributes. Scientific sophistication is needed to deliver the appropriate solutions.

Our Solution

Solvias uses an array of advanced technologies, including UPLC, LC-MS, CE-MS, biospectroscopy, capillary electrophoresis, amino acid analytics, cGMP-compliant AUC, and next-gen sequencing. We tailor testing programs using a comprehensive range of orthogonal analytical methods.

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The Challenge

The innovative nature of these therapies often places us in uncharted compliance territory. Despite several guidelines from various agencies, clear paths for compliance are not always evident.

Solvias Solution

Solvias supports CGT developers from early stage to commercialization, navigating the regulatory requirements to bring your innovation to its destination. Our scientists are well-versed in the ever-changing regulatory landscape for CGTs, employing risk-based strategy to ensure compliance even in the absence of detailed product-specific guidelines.

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The Challenge

Staying on schedule is critical for the development of cell and gene therapies. For companies scaling up, rising production volumes heighten the challenge of meeting tight deadlines.

Solvias Solution

We deliver customized solutions rapidly, accelerating the delivery of data and achieving “right first time” results.

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Broad Capabilities Covering

A Variety of Modalities

1

Viral vectors

4-1

Cell-Based Therapies

3

Gene Edited Therapies

2

mRNA

Don't Take Our Word for it

Our Customers

“The Solvias team's expertise in genomic characterization has helped us establish the assays needed for each of our CRISPR genome-edited CAR-T cell therapies.”
readtestimonialcaribou3
Scott Gradia, PhD
VP of Platform Research, Caribou Biosciences
“The scientific delivery of this quality work from the Solvias team exceeded industry standards. The team are masters of their craft.”
Doug Daniels
Sr. Director of QC, Veloxis Pharmaceuticals
“The drug delivery and physical characterization team provided outstanding support to fine tune analytical methods, perform product specific characterization studies and to complete in vitro BE studies required for product filing at the US FDA.”
Clarissa Gobetti, PhD
CSO, Phargentis
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