Molecular Biology Services

The value of an in vivo study is determined as much by what is measured at its conclusion as by how it was designed. A tumor growth curve establishes that an effect occurred; molecular and pathology endpoints establish why. Altogen Labs provides the analytical services that convert a treated animal into a mechanistic result, and performs them in the same facility that runs the in vivo work, so sample handling between collection and analysis is controlled rather than assumed.

The service covers gene expression analysis by RT-PCR and qPCR, protein expression analysis by capillary and conventional Western blot, RNA, DNA, and protein isolation, immunohistochemistry, histopathology, flow cytometry, cytokine analysis, clinical pathology including blood chemistry and hematology, and necropsy with tissue collection.

Altogen Labs has delivered these endpoints for pharmaceutical and biotechnology clients across oncology, immunology, metabolic disease, and nucleic acid therapeutic programs, in exploratory studies and in work intended to support regulatory filings. Company scientists have published peer-reviewed research using these methods and understand the documentation and reporting standards that separate data usable in a submission from data that is merely informative.

Why integration matters

Analytical endpoints are often treated as a downstream afterthought, commissioned separately once an in vivo study has closed. That sequence introduces avoidable failure. Tissue not stabilized appropriately at necropsy will not yield usable RNA. A tumor fixed for histology cannot subsequently be used for protein work. A flow cytometry panel designed after the fact cannot be run on tissue frozen rather than processed fresh.

Specifying endpoints at protocol stage removes these failures. Altogen Labs defines the endpoint panel, tissues required, preservation method for each, and collection sequence at necropsy before the study opens, so a single animal supports histology, molecular analysis, protein work, and archival storage rather than forcing separate cohorts for each readout. This reduces animal numbers and eliminates the inter-animal variance that arises when different endpoints are measured in different subjects.

To discuss an endpoint panel for a planned study, request a quote.

Nucleic acid and protein analysis

Gene expression analysis measures target transcript levels against selected reference genes, with primer and probe design, amplification efficiency verification, and normalization strategy defined per project. Applications include target engagement and pharmacodynamic confirmation, verification of knockdown or overexpression, and biomarker measurement in treated tissue.

Protein expression analysis quantifies target abundance and post-translational modification state. Capillary electrophoresis based immunoassay offers greater sensitivity and lower sample consumption than conventional Western blot, which matters when available tissue is limited, as it frequently is with small tumors or scarce patient-derived material. Both formats are supported and the choice follows sample availability and required dynamic range.

Isolation services supply nucleic acid and protein from cultured cells, tumor tissue, and other organs, with method selected for the downstream application and yield and integrity assessed before release.

Pathology and cellular analysis

Immunohistochemistry resolves questions homogenate-based methods cannot, because it preserves spatial information. Whether a marker is expressed uniformly or focally, whether immune effector cells penetrated the tumor or remain confined to its margin, and whether proliferation and apoptosis are distributed evenly across a lesion are spatial questions, and all are commonly decisive in interpreting a treatment effect.

Histopathology provides tissue-level assessment of tumor architecture, necrosis, viable tumor fraction, and treatment-related changes in non-target organs. Flow cytometry quantifies populations in blood, tumor, spleen, and marrow and is the primary method for immune profiling in immuno-oncology work. Cytokine analysis measures soluble mediators in plasma and tissue. Clinical pathology provides the systemic tolerability readout accompanying efficacy and toxicology studies. Necropsy and tissue collection is the procedure on which all of the above depend, conducted to a defined sequence with preservation matched to each downstream endpoint.

Applied examples

Knockdown confirmation. Following systemic administration of a formulated siRNA, liver and kidney are collected at defined timepoints, RNA is isolated, and target transcript levels are measured by qPCR against vehicle controls, with target protein reduction confirmed by Western blot in the same tissue.

Immune infiltration. Tumors from a checkpoint inhibitor study are sectioned and stained for CD8, CD4, and a proliferation marker, with infiltrating cell density quantified separately in the tumor core and at the invasive margin, so that an increase in total infiltration is not confused with accumulation at the periphery.

Tolerability signal. In a repeat-dose study, blood chemistry and hematology panels taken at interim and terminal timepoints identify a transaminase elevation that precedes any change in body weight, allowing the finding to be correlated with liver histopathology from the same animals.

Applications beyond in vivo studies

These services also support work that does not involve animals, including characterization of stable cell lines during development, validation of knockdown in RNAi programs, and quality assessment within cell banking workflows.

Method validation and reporting

Assay method, antibody or primer selection, controls, replicate structure, acceptance criteria, and reporting format are specified per project before work begins. Where an endpoint supports a regulatory objective, method suitability is established in advance rather than assessed retrospectively, and raw data are retained alongside analyzed results. Procedures involving animals are conducted under active IACUC protocols, and GLP standards are applied where a study is formally designated as GLP.

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