Efficacy, safety, and formulation issues of the combined vaccines.

Introduction: Controlling the preventable infectious diseases is the main goal of vaccination. Among the vaccines, combined vaccines are of great importance for their social, public health, and economic values. It is stated that the combined vaccines are as efficient and safe as the monovalent vaccines. However, a concern has raised about the efficacy and safety of the combined vaccines due to the outbreaks of vaccine-preventable diseases and occurrence of serious adverse events. Areas covered: A retrospective literature search was conducted in the Google Scholar and PubMed databases to evaluate the efficacy and safety of the combined vaccines from 1980 to 2020 using appropriate keywords. Expert opinion: Several studies have shown efficacy and safety issues related to the combined vaccines. Different factors contribute to the inefficacy and lack of safety in the vaccines including formulation problems, limited data in the pre-licensure studies and challenges related to imperfection of the post-licensure surveillance systems. For surmounting the mentioned obstacles, there is a need to provide new formulations of the vaccines, revise the vaccines҆ safety and efficacy acceptance standards in the pre-licensure studies, improvement of post-licensure surveillance systems, and education of healthcare staff.

Comparison of Different Nisin Separation and Concentration Methods: Industrial and Cost-Effective Perspectives.

Separation and concentration of biotechnological products are the most important steps of purification stage in downstream processing. In the present study, three nisin separation and concentration methods including salting out by ammonium sulfate, solvent extraction (at 20 °C, 4 °C, and - 10 °C) and direct chromatography of culture medium were compared with each other. According to our results, nisin precipitation by ammonium sulfate at 40% saturation was the most efficient method (yield = 90.04%, purification fold = 168.80). Low yield and fold purification values were obtained by solvent extraction with chloroform (yield = 24.23%, fold purification = 37.43 at - 10 °C) and direct cation exchange chromatography of culture medium (yield = 20.00%, fold purification = 1.80). Also, performing purification steps in low pH values and acidic conditions (pH = 3.0) is essential for efficient nisin purification.

Optimization of Non-Nutritional Factors for a Cost-Effective Enhancement of Nisin Production Using Orthogonal Array Method.

In order to increase nisin production in a cost-effective manner, non-nutritional factors as well as nutritional parameters must be optimized. In this study, optimization of the most important non-nutritional factors for nisin production using orthogonal array method was performed. Optimization of temperature, agitation, age and size of inoculum, medium initial pH value and flask volume/medium volume ratio in de Man, Rogosa and Sharpe (MRS) medium in batch fermentation was accomplished. Nisin was produced by Lactococcus lactis subsp. lactis PTCC 1336 and measured by bioassay method using Micrococcus luteus PTCC 1169 as the nisin-sensitive strain. The optimum levels of non-nutritional factors for maximum nisin production and productivity were obtained as: flask volume/medium volume ratio: 5.00, medium initial pH value: 8.00, inoculum size: 1%, inoculum age: 24 h old (A = 1.7), agitation: 100 rpm and temperature: 27 °C. Under the optimized conditions, maximum nisin production and maximum nisin productivity were 599.70 IU/mL and 37.48 IU/mL/h, respectively.