Star Biopharma Solutions Translational science · Oro Valley, Arizona
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Nine things we are asked to do

Engaged as an independent scientific consultancy by biotechnology sponsors, contract research organisations, diagnostics and ingredient developers, and academic spin-outs.

01Services

Where we are useful

The first six have pages of their own. The remaining three are usually scoped as part of a larger engagement rather than commissioned alone.

Genomic & multi-omic analysis

Bulk and single-cell RNA-seq, WGS and WES, amplicon and microarray data taken from raw files through to pathway-level conclusions and publication-grade figures.

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Strain ID & GRAS safety

Whole-genome taxonomic identification to strain level, genome characterisation, and systematic screening for resistance determinants, virulence factors and toxigenic potential.

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Preclinical programmes

Model selection, endpoint definition, power and sample-size rationale, protocol authorship, and independent review of what your vendors send back.

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Histopathology & imaging

IHC and immunofluorescence assay development on FFPE and frozen sections, confocal imaging, whole-slide scanning, QuPath quantification and scoring strategy.

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Biomarker & IVD strategy

Moving a discovery-stage signature toward an assay a clinical or diagnostic programme can actually use, with the regulatory pathway in view from the start.

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Organoid & ex vivo models

Organoids established from primary surgical and biopsy tissue under IRB approval, tumoroid systems, and ex vivo orthotopic models for patient-specific compound testing.

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Immunophenotyping & cell therapy characterisation

12+ colour flow cytometry panel design, compensation, gating strategy and FlowJo analysis, including characterisation of genetically modified T-cell products.

Scientific & regulatory writing

IND-enabling nonclinical summaries, study protocols and reports, GRAS safety narratives, IACUC and IRB submissions, manuscripts and SBIR/STTR proposals.

CRO selection & sponsor-side oversight

Independent technical review of vendor deliverables so problems surface before they become expensive. No instruments of our own, so no stake in the answer.

02Indications

Where the experience is deep

Fifteen years concentrated in rare pulmonary, neonatal, cardiovascular and oncology disease, with microbial safety work drawing on a microbiology background.

Pulmonary & vascular
Pulmonary arterial hypertension, hypoxic pulmonary hypertension, pulmonary fibrosis, bronchopulmonary dysplasia, congenital diaphragmatic hernia
Neonatal & perinatal
Necrotising enterocolitis, neonatal hypoxic-ischaemic brain injury, intra-amniotic inflammation, fetal systemic inflammatory response
Cardiovascular
Sickle cell cardiomyopathy and ventricular arrhythmia, myocardial infarction imaging, diastolic dysfunction genomics
Neurology
Peripheral nerve injury and Schwann cell repair, allopregnanolone neuroprotection in hypoxic-ischaemic injury, genomic profiling in undiagnosed rare neurological disease
Microbial & food safety
Probiotic, starter culture and fermentation strains, taxonomic identification, resistance and virulence screening, GRAS safety assessment
Oncology
Breast (hormone-receptor positive, aromatase-inhibitor resistant), colorectal and FAP, pancreatic neuroendocrine, lung, gastric metaplasia; experimental carcinogenesis and drug repurposing

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Not sure which of these you need?

Describe the problem rather than the service. Most engagements turn out to span two or three of these, and the scoping conversation is free.