Stable Liquid Formulation Development

Stable Liquid Formulation Development - Creative Biolabs Vaccines may need lyophilization to be stable enough for use in developing countries, which adds significant cost burden. The development of stable liquid-form vaccines not only significantly increases yields, but also significantly improves the use and accessibility of vaccines in low-resource settings. Creative Biolabs is experienced in formulation development of vaccines including validated analytical assays and tools. We have established a comprehensive database and algorithm-based formulation platform which can help you explore the best formulations with high success rate and short timeline.

Vaccine Excipients

In addition to weakened or killed disease antigens, the vaccine contains very small amounts of other ingredients - excipients. Developing a stable, low-cost liquid formulation will help manufacturers to better accept and reduce production and distribution costs by eliminating freeze-drying requirements. Suitable excipients can affect the forces of molecular conformational stability, such as van der Waals interactions, electrostatic interactions, hydrogen bonding, and hydrophobicity. Excipients added to the vaccine for particular purposes include:

Stable Liquid Formulation Development - Creative BiolabsPreservatives

Preservatives have been used in vaccines for many years to prevent harmful contamination of vaccines. Preservatives have proven to be safe and effective with few serious adverse events. The most commonly used preservatives are 2-phenoxyethanol, Phenol, and Thimerosal.

Stable Liquid Formulation Development - Creative Biolabs Stabilizers

Stabilizers block the chemical reactions of the vaccine components, preventing the components from separating from each other or sticking to the vials during transportation and storage. The native conformation of biologics, for example, can be stabilized by high concentrations of saccharides such as sucrose and lactose, amino acids such as glycine and monosodium glutamate, proteins such as recombinant albumin from baker's yeast or fetal bovine serum and gelatin.

Stable Liquid Formulation Development - Creative BiolabsBuffer

Protein solubility can usually be increased by adding an appropriate amount of salt. Salt is also used as a tonicity modifier. However, in some cases, it may have a negative impact on conformational stability. Therefore, the choice of counterion and their concentration are critical to altering the stability characteristics of the biologic. For example, different buffer conditions of different compositions (i.e., various ionic strengths) can be used to achieve the same pH conditions, and thus the stability of the protein can be altered. The addition of surfactant also increases the stability of vaccines. Surfactants can inhibit the adsorption, denaturation and/or aggregation of proteins at the interface (air-water and solid-water), and can also affect stability by combining with differences in the natural or denatured state of the protein.

Unlike excipients, some other residual trace materials are needed to be used during the manufacturing process and removed, including cell culture materials (used to culture vaccine antigens), inactivated components (for killing viruses or inactivating toxins, such as Formaldehyde), antibiotics (used to prevent bacterial contamination, such as neomycin). Formulation technology platform of Creative Biolabs is based on a library of up to hundreds of different, regulatory well-known excipients. In terms of the extensive experience in formulation optimization, we are proud to offer our clients formulation development services with the most competitive price and best quality.

Our services are for research use only. We do not provide services directly to individuals.

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