Each vaccine development roadmap will be unique because:
- The wide range of technologies now used to make vaccines
- The diverse nature of the pathogens and diseases that are being targeted
- The complexities of the human immune response
Discussions with experts and regulators at appropriate times during development are critical for your success. Celerion has the experience and expertise to assist with these discussions and provide guidance into early clinical development and pivotal efficacy and safety studies.
Celerion’s global clinical development group’s unique capabilities will help you manage your studies:
- Timely recruitment of patients or healthy subjects meeting the unique inclusion/exclusion criteria and potential antigen exposure requirements of the protocol
- Established relationships with high performing sites and site networks
- Access to patients or healthy subjects in geographies where the pathogen exists for later stage clinical trials to establish extent of protection vaccine provides
- Full service clinical study management to coordinate supply chain, dosing, clinical monitoring, drug surveillance, site and sponsor communications and financial transactions for the study
- Integrated data management, bioanalytical support, biostatistics and medical writing services
- Robust assay for measuring antibody concentration in response to the antigen
- Established methods to determine the percentage of functional antibody capable of producing a bactericidal effect, neutralizing a virus or toxin, or eliciting a specific immune cell response
- Celerion clinics provide an experienced, trained staff to store, prepare and administer test vaccines, assess safety and tolerability, and manage complex blood sample handling, storage and shipping procedures
Our bioanalytical sciences lab, with over four decades of pharmaceutical methods development, provides a unique resource to aid in the development of vaccines in an efficient and cost-effective manner. Our bioanalytical sciences team is skilled in developing innovative custom assays in collaboration with our clients.
Having invested heavily in robotic automation technology that greatly increases throughput and results in greater precision for the assays, Celerion is well positioned to handle large volumes of samples that need to be analyzed quickly as well as maintaining cost effectiveness in an increasingly competitive market.
Our diverse and state-of-the-art technologies, capabilities and services support vaccine development:
- Immunology assays
- Eelectrochemiluminesence MSD®) – Singleplex and multiplex assays
- Luminex Multiplexing assay
- Molecular Biology assays
- Cell-based and functional assays
- Specialized methods for PBMC isolation
- Flow cytometry- vaccine-induced T cells response, phenotyping assays etc.
- Mucosal tissue samples can be examined using flow cytometry
- Opsonophoagocytic assays (OPA/OPK/MOPA)
- Enzyme-linked immunospot (ELISPOT)
- Cell-mediated immunity methods