Process Development for H. pylori Vaccines

Production costs account for a large proportion of vaccine research and development, and the goal of process development is to save costs and produce efficiently while maintaining quality.

Small-scale process development

The development of small-scale process models for H. pylori vaccines is about establishing the relationships between various factors and production outcomes that affect the scaled-up models. In addition, to better characterize and optimize processes, small-scale model development must be scientifically and carefully designed for process understanding, prediction, and control. Ace Therapeutics has extensive experience in the production of H. pylori vaccine antigens and vaccine adjuvants. We can provide key quality attributes for H. pylori vaccine production and provide better solutions to monitor these key attributes. In addition, we can provide small-scale model selection and parameter ranges evaluation, which is essential for the calibration of small-scale models to reliably predict scale-up performance. With the effort of our specialized computer staff, we can develop a suitable computer simulation system for small-scale model production of H. pylori vaccines. This system facilitates parameter documentation, production relationship identification, and model optimization.

We conduct small-scale process development of the H. pylori vaccine in 5 steps.

1. Determine critical quality attributes and give detailed descriptions and test solutions of them.
   Our H. pylori vaccine antigen database documents the properties of H. pylori vaccine antigens, and we have in-depth knowledge of H. pylori vaccine adjuvants. These two points give us a definite design advantage in developing small-scale processes for H. pylori vaccines.
2. Record experimental data and establish underlying causal relationships.
   Using computer simulation systems, we can easily record data and quickly establish causal relationships.
3. Evaluate the validity of the detection parameters.
   Evaluate the validity of detection parameters based on the basic causal relationships.
4. Small-scale assessment and refinement.
   Evaluation and refinement of the relationship between detection parameters and results.
5. Scale validation.
   Designing experiments to verify the causal relationships.

Scale-up development

The prevalence of H. pylori in the population is high, with an overall prevalence of 44.3%, and the prevalence of infection was higher in developing countries. Thus, the development of H. pylori vaccines on a large scale is extremely essential.

Fig. 1 Graphical presentation of prevalence of H. pylori infection across the world (Zamani et al., 2018).

Ace Therapeutics offers solutions for the large-scale manufacturing of H. pylori vaccines. We are committed to creating an easily controlled, reproducible manufacturing process to ensure a long-term supply of high-quality H. pylori vaccines. We start with small-scale process development and then scale up the process. We select equipment and design facility for large-scale manufacturing based on vaccine production simulation systems obtained from small-scale process development to best meet scale-up requirements.

Cooperate with us

If you need process development and process scale-up for H. pylori vaccines, Please contact us for professional services. We are always at your service.

Reference

1. Zamani, M.; et al. Systematic review with meta-analysis: the worldwide prevalence of Helicobacter pylori infection. Alimentary Pharmacology & Therapeutics. 2018, 47(7): 868-76.

※ All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.