Inflammation is an important response to potential threats and harm to our bodies. But with autoimmune disorders such as inflammatory bowel disease (IBD), psoriasis, and others, our immune system can sometimes attack us. These hurting and devastating circumstances can significantly impact a patient’s quality of life. Also, several of these conditions are sub-optimally managed by existing therapies that only offer symptom relief without looking at the root cause. For a long time, healthcare providers relied on medications such as corticosteroids as anti-inflammatories and immune suppressors. Though an important treatment option, corticosteroids come with a plethora of adverse effects.

Fortunately, science is advancing per your vision, and Cerba Research is there to focus on your I&I research. With increased complexity in I&I protocol design, the emergence of numerous biomarkers, and sometimes the rarity of disease (2), selecting the right contract research organization (CRO) for your trial is important. Don’t worry; Cerba Research has a wide range of integrated specialty and safety testing options in your existing central laboratory processes.

Painful Joints

Cerba Research offers a wide range of expertise that can uniquely support I&I research and development as we offer end-to-end solutions from discovery to post-market authorization for your global/regional trials. In the past 5 years, Cerba Research performed around 80 I&I trials, including phase II and III studies. Notably, the lab has been pivotal in approving 23 innovative drugs for indications like atopic dermatitis, ulcerative colitis, Crohn’s disease, and more.

Our team is experienced in many innovative techniques. We have a global network of laboratories that offers a wide range of capabilities, ranging from safety testing (also known as routine testing) to immunoassays, immunohistochemistry (IHC), flow cytometry (FCM), NGS broad-panel assays, immunogenicity, qPCR, ddPCR, NanoString®, and more. We also facilitate state-of-the-art technologies, subject matter expertise, specialized logistics, and operations to accelerate your I&I research and development.

Thanks to our expertise in assay development, validation (2), customization capabilities, robust kit building, sample management, and logistics, we have garnered about 21,400+ patients screened and 12,500+ randomized from our I&I programs since 2018.

Cerba Research – An Atopic Dermatitis IHC Case Study

The adaptive component of the immune system, also known as acquired immunity, is composed of a highly specialized and diverse population of B and T lymphocytes poised to recognize and eliminate invading pathogens or other sources of unknown antigens.

Applying NGS technologies enables us to profile these populations with high resolution. Whether we are profiling the B or T cell repertoire, parameters such as clonality, diversity, and richness enhance our ability to harness the potential of the clones of interest for therapeutic, diagnostic, or research use.

With our in-depth biologics and biosimilar experience, we support our clients from pre-clinical to post-market authorization. We offer long-standing scientific expertise in pharmacokinetics (PK) and immunogenicity (anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs)) with a standardized or customized approach, as per your vision.

Did you know that Cerba Research Canada was instrumental in the PK and immunogenicity validation and implementation of interferon beta-1a, a protein approved globally for multiple sclerosis (5)? We were also instrumental in the PK and immunogenicity implementation of natalizumab and adalimumab, mAbs approved for various I&I conditions (6, 7).

Our focus extends from mAbs to CGTs, antibody-drug conjugates, and more. In addition, we are Good Laboratory Practice (GLP), the College of American Pathologists (CAP), and Clinical Laboratory Improvement Amendments (CLIA) accredited for your regulatory requirements.

1. Orphanet: The portal for rare diseases and orphan drugs. URL [https://www.orpha.net].

2. Selliah N, Nash V, Eck S, Green C, Oldaker T, Stewart J, Vitaliti A, Litwin V. Flow Cytometry Method Validation Protocols. Curr Protoc. 2023 Aug;3(8):e868. doi: 10.1002/cpz1.868. Erratum in: Curr Protoc. 2024 Jan;4(1):e988. PMID: 37606503.

3. Robles-Remacho A, Sanchez-Martin RM, Diaz-Mochon JJ. Spatial Transcriptomics: Emerging Technologies in Tissue Gene Expression Profiling. Anal Chem. 2023 Oct 24;95(42):15450-15460. doi: 10.1021/acs.analchem.3c02029. Epub 2023 Oct 10. PMID: 37814884; PMCID: PMC10603609.

4. Feyzâ Matisli, Jan Spitaels, Veronica Nash, Amber Baele, Leen Catrysse, Silke De Waele, Miet De Baere, Nithianandan Selliah. Validation of a Flow Cytometry Assay on Cytek® Aurora to Monitor Immune Cells in Peripheral Whole Blood for Clinical Trials. Presented at: European Society for Clinical Cell Analysis (ESCCA); 27-30 September 2023; Utrecht, Netherlands.

5. Rebif® (interferon beta-1a): Highlights of prescribing information. URL [REBIF (interferon beta-1a) Prescribing Information (emdserono.com)].

6. Tysabri® (natalizumab): Highlights of prescribing information. URL [TYSABRI Label (fda.gov)].

7. Humira® (adalimumab): Highlights of prescribing information. URL [Humira (adalimumab) label (fda.gov)].