Question 1

Does RoukenBio service the United States?

Accepted Answer

As a global pharmaceutical contract research organization, RoukenBio provides drug development services to the vast scientific network worldwide. Our scientific partners are based mainly in the USA—particularly in Massachusetts (Boston, Cambridge) and California (San Francisco and San Diego)—Canada (from Vancouver up to Seattle), the UK, and Europe.

Question 2

What types of assays does RoukenBio develop?

Accepted Answer

We provide a complete range of in vitro cell-based assays, from mechanistic and potency studies to immunogenicity and safety assessments, all tailored to your molecule and target biology. We employ a range of cell types; primary immune cells, reporter cell lines, immortalised cells, non-immune primary cells and disease state donor cells.

Question 3

Can RoukenBio develop a custom assay for a novel target or pathway?

Accepted Answer

Yes. Our team regularly develops bespoke immune cell assays for new or complex mechanisms, working collaboratively between our immunobiology and cell engineering teams, to ensure the model captures the biology most relevant to your pre-clinical drug development pipeline.

Question 4

What cell systems do RoukenBio use?

Accepted Answer

We select the right system for your question. In our day-to-day studies, we adopt a mixture of immortalized and engineered cell lines alongside primary human immune cells. These can be comprised of fresh whole blood donations, cryopreserved peripheral blood mononuclear cells (PBMCs) or expanded immune cell banks of different immune cell subsets. We have created a number of antigen specific model systems, such as TCR and CAR engineered immune cells to enable the study of different aspects of immune modulation. All of our primary materials are obtained from ethically consented, informed donors, ensuring biologically relevant, human-specific and ethical results.

Question 5

How do your assays support IND-enabling research?

Accepted Answer

Many of our assays are designed to address questions pertaining to the mechanisms of action of the molecule. We can perform a suite of assays, designed to generate orthogonal data, describing the functional and binding properties of a therapeutic candidate for submission to regulators as part of the in vitro pharmacology data package.

Many of our data packages and reports have been included in IND submissions to regulatory bodies such as the FDA.

Question 6

What makes RoukenBio different from other CROs?

Accepted Answer

We’re immunologists and biologists first. Our cell-based assays are built on scientific understanding with scientific empathy rather than templates, meaning we deliver data with context, precision, and reliability in a truly collaborative approach.