Biologics driving growth for in vivo CROs

The rapid growth of biologics as a class of drugs has fuelled significant demand for in vivo contract research organizations (CROs) over the past decade. Biologics such as monoclonal antibodies, vaccines and gene and cell therapies require animal testing during preclinical development to assess safety, efficacy and other parameters before human clinical trials. In vivo CROs with expertise in pharmacology, toxicology and other preclinical testing services have enabled biotechnology and pharmaceutical companies to outsource this critical development work. As more large molecule drugs enter the pipeline, in vivo CROs are seeing increased business as biologics sponsors rely on their specialized knowledge and facilities to advance candidates towards the clinic.

Regulatory changes shape service requirements

In Vivo CRO is stricter regulatory standards from agencies like the FDA have also influenced the evolving role of in vivo CROs. Sponsors require robust preclinical data packages to satisfy increased requirements for IND filings. This has expanded the scope and complexity of testing performed by CROs. Services such as proprietary disease models, advanced imaging techniques and specialized bioanalysis are in higher demand. CROs have invested heavily to develop these new capabilities in-house. Non-clinic toxicity studies that monitor longer term effects have also increased under new ICH guidelines. Here, in vivo CROs play an important partner role to sponsors in designing robust preclinical programs that meet current regulatory expectations.

Scaling seamlessly to meet project requirements

The scale and timeline of in vivo testing projects can vary widely depending on a candidate's properties and development priorities. To address this, large in vivo CROs have built flexible operations that can ramp skills and capacity up or down swiftly depending on a sponsor's evolving needs. Services include abbreviated toxicology packages for early-stage work through to large GLP safety studies involving hundreds of animals. Many CROs also have the ability to integrate their in vivo work into multi-modality programs involving complementary in vitro and analytical testing. This holistic one-stop-shop capability allows sponsors to streamline outsourcing and maintain a single-source relationship throughout a candidate’s progression. CROs’ investments in advanced scientific capabilities and scalable facilities have created a plug-and-play model that supports sponsors' drug development programs on an as-needed basis.

Specialized testing drives innovation

Pushing the boundaries of scientific knowledge, some CROs have established unique in vivo testing capabilities to support novel modalities. For cell and gene therapies, this includes developing animal models of relevant human diseases and furthering analytical methods specific to these complex biologics. Bioanalytical assays, biomarker research and imaging techniques have also enabled in vivo evaluation of innovative drug targets. Investigative CRO services apply scientific rigor to explore first-in-class concepts and validate new therapeutic hypotheses using animal models before human testing. By spearheading specialized testing approaches, in vivo CROs play a role in advancing drug development methodologies, particularly for disruptive technology platforms like RNAi, gene editing and other cutting-edge areas. Overall, their preclinical scientific expertise remains invaluable to ushering innovative new medicines towards the clinic.

Tackling preclinical supply chain challenges

The globalized pharmaceutical supply chain has amplified the importance of in vivo CROs’ logistical role. International sourcing of candidate materials and animals introduces complex import/export and transportation considerations that in vivo CROs effectively navigate on sponsors’ behalf. They maintain diverse global supplier relationships and facilities approved under international standards like the OECD Principles of Good Laboratory Practice. This establishes a standardized preclinical testing environment to accommodate multi-region sponsors’ supply demands. CROs provide logistical project management support through material shipment, inventory and timely animal availability – smoothing out supply uncertainties. For long-term toxicology programs, they ensure animals are procured from reliable breeders around the world and colonies are maintained on-site. The supply chain competencies of large in vivo CROs have made them indispensable partners as preclinical outsourcing increases across broader geographies and regulatory landscapes.

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