Vaccine Formulation Development

Pre-formulation study

It includes biochemical analysis of biomacromolecules, amino acid sequencing, establishment of analysis methods for stability indexes, and analysis of biophysical properties under pH and ionic strength. These studies contribute to the in-depth understanding of the degradation pathways of biomolecules, so that the ideal excipients and protectants can be selected to meet the specific needs.

Vaccine formulation research

The effects of stress conditions (such as pH, temperature, freeze-thaw, drying, shearing) on molecular structure (such as secondary and tertiary) and function (such as activity, titer, binding force) were explored by using high-throughput prescription research methods to comprehensively understand the behavior of macromolecules under various stress conditions. Most vaccines are liquid preparations, and if the initial liquid formulation strategy does not meet the requirements of the target product characteristics, it is recommended to develop a freeze-dried product using a suitable freeze-drying process. Oral vaccines are given by the oral route and are suitable for the immune response of the digestive system. The nasal vaccine is administered through the nose in a spray form and is intended for upper respiratory tract immunization. The topical adhesive vaccine in development is a relatively novel form and is expected to be administered locally through the skin with an immune effect similar to that of injection. Nanotechnology is used to deliver mRNA and inactivated vaccines.

Vaccine formulation optimization

In the formulation process optimization, the most important content is excipient optimization. The excipients used in vaccine preparations mainly include various buffers, salts, lyophilized protectants (sugars)/fillers, surfactants, antibacterial preservatives, etc., which are designed to optimize the environment around the protein through excipients to maintain its conformation and colloidal stability, reduce interactions between neighboring protein molecules, and block the interaction between the protein and the container surface. And then improve the stability of biologics.

An agonist of the natural immune system or a carrier selectively present at an antigenic target is added to the formulation of a vaccine formulation, known as a vaccine adjuvant. It has an important impact on the immune effect produced by vaccination, can improve the persistence of antigen, broad spectrum, strong and its inherent immunogenicity, reduce the amount of antigen and/or the number of immunizations required to achieve the efficacy, and its self-toxicity is minimal, and the immune effect is long-lasting. Aluminium hydroxide, aluminium phosphate and alum adjuvants are the most commonly used adjuvants in human vaccines.

Vaccine formulation analysis

Compatibility of vaccine components: Ensure that the various components of the vaccine (such as antigens, adjuvants, co-ingredients) can remain chemically and physically stable after mixing, and will not interfere with each other.

Formulation stability: Evaluate the stability of the vaccine under different storage conditions (temperature, humidity, light) to ensure that the vaccine will not fail during long-term storage and transportation.

Toxicological studies: Acute toxicity tests are typically administered with a single high dose (often several times the lethal dose in animal models) to assess whether a vaccine causes acute adverse effects, including death, organ damage. It is also necessary to evaluate the safety of the vaccine under long-term use and whether it has immunotoxicity.

Immune response testing: Use animal models (usually mice, rabbits, monkeys) to assess whether a vaccine can induce a specific immune response. Serum antibody levels are measured using ELISA, and T cell responses, such as activation of CD4+ and CD8+ T cells, and cytokine secretion, are detected by techniques such as flow cytometry (FACS).

Potency testing: After vaccination, animals are exposed to the corresponding pathogen (such as pathogenic viruses, bacteria) to assess whether the vaccine is effective in protecting the animals from infection or reducing the severity of infection. Evaluate the effects of different doses of vaccine on immune response and protective efficacy to determine the optimal immune dose.

Formulation Stability Study

Preparation Quality Research

Nano Formulation Analysis and Verification

Laboratory-scale Preparation Testing

In Vivo   ADME

General Toxicology

Immunotoxicology

Genetic Toxicology

Toxicokinetics

Safety Pharmacology

Specialized Toxicology

Development and Reproductive Toxicology

Standard for Exchange of Nonclinical Data (SEND)

Vaccine formulation manufacturing

BOC Sciences has established a GMP-compliant preparation workshop with advanced equipment and complete functions to provide corresponding drug production and packaging services for clinical trial research. And we also support all steps of protein production including the mutagenesis and cloning of target genes in expression vectors, the heterologous expression in prokaryotic and eukaryotic hosts, as well as the subsequent purification of the corresponding proteins as a service.