Stability Development Services

Creative Biolabs is a global leader dedicated to microbial formulation. We have invincible knowledge in drug formulation development and provide professional and comprehensive services in live biotherapeutic products (LBPs) development, especially concerning the stability of LBP products.

Introduction

To produce manageable, easily applied and storage-stable biological products, biological and physical stability must be achieved through the formulation and drying of microorganisms. Even though, drying and storage will inevitably expose microorganisms to environmental stress.

The LBP is harvested and concentrated living organisms. It is a dosage form that is easy to use, ensures an accurate dosage content and the quality of the active ingredient. Like current biological agents, microbial APIs also suffer from thermal and chemical denaturation. Despite the fragile lipid membrane, this vulnerability challenges stability in the process of manufacturing, storage, and administration. In terms of storage stability, current microbial APIs require cold-chain storage to maintain potency. In some cases, this even means storage at cryogenic temperatures.

Fig.1 Various steps involved in the stability study. (Maheshwari, 2018)

Physiological State Optimization Services

To optimize the physiological state of the cells before lyophilization, the tolerance of the microorganisms can be increased. Creative Biolabs has developed several methods to facilitate this optimization.

• The first strategy is to optimize the growth conditions according to the medium composition and abiotic cultivation parameters so that the maximum stress resistance in the stationary phase is obtained.
• The second strategy is to pretreat or stress cultured cells by exposure to non-lethal environmental stressors. Microbes can sometimes be better trained to cope with harsh conditions. Little stress can enhance fitness and better chances of surviving under stress.

Excipient Formulation Optimization Services

The biological adaptation itself is not enough to ensure the high survival rate in dried biological products, It is also necessary to add compounds to provide external protection from the harmful effects of freezing or drying. These additives are usually substances that can be produced by microorganisms themselves and used to protect internal, such as disaccharides, amino acids, and various amino acid derivates. Production of these compounds is usually a response to pressure or pretreatment, survival can be generally be improved by including these compounds in the formulation. However, each new microorganism will likely need to be individually optimized for the pretreatment scheme and formulation additives.

According to the characteristics of your products, Creative Biolabs will provide you with the best-customized excipient formulation service to maximize the stability of your products.

Stability Storage and Testing Services

Stability is determined for the drug substance as well as the drug product and is necessary to anticipate product efficacy loss during shipping or storage. The shelf life is defined based on the stability data to ensure that the dosage claimed efficacious is indeed present during the complete claimed shelf life. Therefore, stability studies should be carried out for all intermediaries, drug substances, and drug products in an LBP's final formulation and packaging. The stability of drug storage is very important to maintain its function, your product stability can be evaluated under different conditions relevant to the actual lifecycle of the product on the market by Creative Biolabs. We simulate the performance of your product over some time by accelerating aging so that you can get results quickly and enter the market with confidence.

• Testing for different formulations of LBPs.
• Testing for different live organisms.
• Temperature and humidity testing.
• Analytical support for stability.

Creative Biolabs offers well-established and innovative One-Stop-Shop LBP development solutions. Our team of highly qualified and experienced technical staff will work with you to develop and deliver testing and analytical solutions for product stability. If you are interested in our services, please contact us for more solutions.

Reference

1. Maheshwari, R.; et al. Stability and degradation studies for drug and drug product. Dosage Form Design Considerations. Academic Press. 2018: 225-257.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.