Complex Vaccine Development

Tackling the Complexities of Vaccine Development

The diverse nature of the pathogens and diseases that are being targeted combined with the intricacies of the human immune response exponentially increases the complexities of vaccine development. Celerion recognizes that access to experts and regulatory guidance at the appropriate times of your development plan are critical for your success. We have the experience and expertise to assist with these discussions and provide guidance into crucial early clinical development as well as pivotal efficacy and safety studies.

Patients or Healthy Subjects?

Timely recruitment is important whether you require patients or healthy subjects that meet your inclusion/exclusion criteria and potential antigen exposure requirements of the protocol. Through Celerion’s established relationships with high performing sites and site networks, we provide you access to patients or healthy subjects in geographies where the pathogen exists for later stage clinical trials to establish safety and efficacy.

Full Service Study Management

Working with your team, Celerion 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. We enhance your capabilities with as much or as little assistance as you need, including: integrated data management, bioanalytical support, biostatistics and medical writing services. Celerion provides 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. Celerion has established innovative methods to determine the percentage of functional antibody capable of producing a therapeutic effect, neutralizing a virus or toxin, or eliciting a specific immune cell response.

Our bioanalytical 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. To better serve our customers, we have 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 while maintaining cost effectiveness in an increasingly competitive market.

• Our track record spans both preventive and therapeutic vaccines, subunit and conjugates across all phases I-IV in more than 20 countries, 300 study centers and 4500 subjects.
• Celerion’s expertise spans a large variety of vaccines within Infectious Diseases, Oncology, and Autoimmune Diseases
• Celerion’s experience includes different routes of administration, and patient populations.