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 drug development phases do you support at RoukenBio?

Accepted Answer

As a pre-clinical immunology CRO and comprehensive solutions provider, we cover the full spectrum of discovery to pre-IND testing including:

Target biology validation
Lead selection
Lead optimisation and characterisation
Product characterisation

We have a strong foundation in biotherapeutics including biologics (e.g. antibody and protein/peptide-based molecules) and cell-based therapies. However, we are modality agnostic and can functionally characterize any immunotherapy.

In addition to enabling drug discovery of novel therapeutic candidates, we provide extensive analytical biosimilarity services for the characterization of biosimilars.

Our specialized CRO services redefine the traditional drug discovery process. Acting as an external partner, we create custom approaches and develop novel, innovative technologies, like our IndEx-2 platform, driving real innovation across the full drug discovery process.

Question 3

How does RoukenBio differ from other CROs?

Accepted Answer

Our unique, consultative approach champions collaboration which sets us apart from traditional CROs. You’ll have knowledge on tap with our cross-functional in-house group of life sciences experts; molecular biologists, cell biologists, cell engineers, biophysicists, oncologists and immunologists.

Our brilliant minds have directly supported the development of new drugs for inflammatory diseases, allergies, auto-immune disorders, infectious disease and cancer, particular in the immuno-oncology field. Our biologists work alongside you, scientist to scientist, to create in vitro assay systems designed to address your unique drug development questions.

Our consultative approach is grounded in scientific empathy, many of our scientists have been in your shoes, driving their own drug development processes, meaning we are powered by scientific experience, but driven by people. We infuse our experience into each interaction and welcome everyone we work with as teammates. We share your goals. United by one purpose, we strive to create an environment where success can thrive.

Question 4

What specific therapeutic areas do RoukenBio specialize in?

Accepted Answer

We have extensive expertise in oncology, immuno-oncology, autoimmunity, allergy and inflammation. Our adaptable assay platforms are designed to address the unique challenges of these therapeutic areas and importantly, consider the immune cell components and drivers of each pathology.

With expertise spanning a range of disease areas, we develop innovative assays to support the development of cutting-edge treatments in oncology, immuno-oncology, autoimmunity, allergy, inflammation and beyond.

Question 5

What modalities do you support in drug discovery and pre-clinical development?

Accepted Answer

As a pre-clinical CRO, we focus on established and emerging therapeutic classes, including:

Antibody-based molecules, including IgG, IgE, IgM, IgA
Monoclonal antibodies (mAbs)
Bispecific antibodies (BsAbs) and multi-specific antibodies
- T cell engagers; tumour associated antigen (TAA) targeted or peptide-MHC (pMHC) targeted
- Natural killer cell engagers
- Myeloid engagers
- Other immune cell engagers
Immunocytokines and fusion proteins
Antibody drug conjugates
- Cytotoxic payloads
- Immunostimulatory conjugates (ISAC)
- antibody-oligonucleotide conjugates
Cell therapies
- T cell, myeloid and natural killer cell based e.g. CAR-T, CAR-NK, CAR-M, gamma delta CAR
- T cell receptor engineered (TCR-T)
Targeted protein degraders
Small molecules
RNA-based and oligonucleotide-based therapies
Nanoparticles
Complex biologics
Peptides and recombinant proteins
Biosimilars

Question 6

What types of services do RoukenBio provide?

Accepted Answer

Our services can be broadly simplified into the characterization of the functional and binding characteristics of novel therapies in the preclinical stages of drug development and non-regulated clinical phase testing. We achieved this by employing three main areas of expertise;

Our immunologists are concerned with the biology of the drug, how the molecule exerts its mechanisms of action (MoAs) and what the most relevant MoAs are that should be considered and investigated. The immunology team develop the correct model systems and primary cell assays to understand the behaviour of therapeutic candidate molecules as fully as can be achieved in an in vitro setting.

Applications range from the (i) high throughput screening of hundreds of molecules with simplified, cell-based assays e.g. using 384-well plates, (ii) primary cell assays for a triaged number of candidates, to (iii) more comprehensive mechanistic characterisation of a few lead candidates in complex primary cell co-culture and 3D primary cell assay systems.

Our bioanalytical team are bioassay specialists. When an important MoA has been defined, our bioassay team are able to create clear, defined assay systems to be able to reliably and consistently measure how a molecule behaves against a set of specific criteria. The team can develop qualified cell-based assays that can be used for stability assessments, analytical biosimiliarity studies, product characterisation and development of release assays for clinical phase product lot release.

Our cell engineering department are there to generate the cell line tools needed for our immunology and bioanalytical teams to meet their assay goals. Our very own ‘molecular wizards’ embrace problems with enthusiasm and rise to the challenge of designing novel molecular solutions, to create completely novel and bespoke cell lines, to address unmet needs at the forefront of the ever-advancing drug discovery industry.

From target cell lines, knockout and knockdown cell lines, inducible expression (such as IndEx-2), novel reporter cell systems and primary cell engineering (e.g. CAR-T and TCR-T), the experience of the team is broad and welcomes any challenge.

Question 7

Can RoukenBio customize solutions for unique and complex projects?

Accepted Answer

With a world-leading Net Promoter Score (as rated by our customers), we know that this is what we are most valued for; our unique capability of working with emerging modalities and less well-described targets. We aim to be the first to imagine new solutions and deliver new methodologies to appropriately test these therapeutics. We thrive in the unknown; complex bioassay development, tricky primary immune cell assays and novel safety and efficacy assessments just to name a few.

Difficulty doesn’t deter us; it inspires us. Let us showcase our innovative thinking and problem-solving prowess. Give us a problem, and we’ll find your solution across oncology, immuno-oncology, autoimmunity, allergy, inflammation and infectious disease.

Drug Development Services

Comprehensive Support Across Every Development Phase up to IND submission

Explore our core drug development solution areas:

Phase

Therapeutic Antibody Development and Modalities

Therapeutic Focus: Immunotherapy Solutions

Propel drug discovery breakthroughs with RoukenBio

FAQs