Analytical Services for Vaccine Development
Analytical Services for Vaccine Development
Analytical and bioanalytical methods are essential in vaccine development, ensuring safety, efficacy, and quality at every stage. These techniques offer vital insights into the product’s identity, purity, stability, potency, and safety. They are pivotal in assessing immune responses during both preclinical and clinical phases and in upholding strict quality control during manufacturing. By enabling precise characterization and evaluation, these methods facilitate the creation of vaccines that adhere to rigorous regulatory standards and effectively address global health challenges.
Our Expertise
Take advantage of our expertise in genomics, proteomics, and immunoassays and let Avance Biosciences support your vaccine development and manufacturing campaigns. We assist clients with all vaccine types, including mRNA vaccines. Explore our comprehensive service offerings, categorized into preclinical studies, clinical studies, and Chemistry, Manufacturing, and Controls (CMC). Our tailored analytical solutions are crafted to accelerate each stage of vaccine development, ensuring rigorous testing for safety, efficacy, and quality assurance.
Analytical Support Through All Stages of Product Lifecycle
Phase
Technologies
Applications
Preclinical Studies
Cell-Based Assays, qPCR, ddPCR, PCR, Flow Cytometry, ELISA, MSD, LC-MS/MS
Clinical Studies
CMC Support
Regulatory Guidance
FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). FDA is committed to providing timely guidance to support the response to COVID-19. The recommendations...
This technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics...
We, FDA, are issuing this guidance to provide you, investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA) or a supplement to a BLA (BLA supplement), with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and...
