Are you curious how vaccines are made? Or about the research and time that goes into their development? The U.S. Food and Drug Administration’s Center for Biologics Evaluations and Research, CBER for short, is the organization in the United States that oversees and is responsible for regulating vaccines. Vaccine development is a long and complex process that can sometimes last as long as 10-15 years!
The development of a new vaccine begins with what researchers refer to as the exploratory stage. In the exploratory stage, basic laboratory research is performed identifying both natural and synthetic antigens such as weakened viruses and bacteria, toxins, and other particles that have the potential to prevent or treat diseases.
Following the exploratory stage is the pre-clinical stage. In this stage of development, researchers use tissue or cell cultures to assess the vaccines safety and ability to provoke an immune response. The purpose of this stage is to give researchers a clue as to what the cellular response from people may be. This phase also helps researchers determine safe dosages and safe methods for administering for the next phase of research. Alterations at this stage can make the vaccine more effective. It is not uncommon for vaccine development to stop at this point if positive immune responses are not occurring.
Once the pre-clinical testing is done, a company or sponsor submits an application for an IND, Investigational New Drug, to the FDA. The application requires the sponsor to describe the manufacturing and testing processes the vaccine has gone through, as well as laboratory reports. A review board has 30 days to approve of deny the application, that once approved allows the vaccine to enter the clinical studies/clinical development phase.
During clinical development, a small group of adults is chosen to test the vaccine’s safety as well as to observe the immune response. If the vaccine produces the desired immune response, it moves on to more testing with a larger group of subjects. The next round of testing studies the safety, immunogenicity, dosage, delivery method, and proposed schedule for delivery. When the drug passes this round of testing it moves onto the final phase of clinical development involving testing with thousands of people. These final tests involve testing the vaccine against a placebo. The goal of this type of testing is to assess any side effects and efficacy.
If a vaccine passes all stages of clinical development testing, the next stage it enters is review and approval. The vaccine developer first submits a Biologics License Application where the FDA approves the facility and the labeling.
Need a laboratory for vaccine development research or testing?
Contract Laboratory has helped many companies and organizations find laboratories for their vaccine development research and studies, such as:
- Pharmaceutical laboratory needed for non-clinical safety study of DNA vaccine.
- Lab needed for long-standing relationship for antibody production, ELISA, and neutralization testing for synthetic peptide vaccine.
- FDA GLP / GMP Bioanalytical laboratory needed for protein analysis for the protein concentration in toxoid vaccine. The adjuvant is alum.
- Laboratory needed for Quality testing of Influenza Candidate Vaccine virus stock(as per 21 CFR Part 58) for the below. Adventitious viruses testing (as per 9 CFR Part 113.53 ) HIV, HAV, HBV, HCV and Paro Virus B19 testing (as per CHMP/BWP/268/95 and FDA ?Guidance for Industry – Nucleic Acid Testing (NAT)
- BSL-3, FDA GLP preclinical CRO needed for Hapatitis C vaccine candidate testing
- United States Biotechnology contract research organization needed for hemagglutination inhibition antibody testing against the current human vaccine strain viruses. Estimate 30 serum samples to test against 3 different influenza virus strains.
- Laboratory needed for cGMP Vaccine Testing of 3 batches for: Sterility test Formaldehyde testing Viscosity in emulsion Real time PCR
- plus many more!
If your organization is looking for a laboratory to help perform your vaccine development, vaccine research or other vaccine testing, call us at 1-855-377-6821, or submit a vaccine test request on our website!