Lyophilised Formulation Development
The properties of high stability, easy to storage and transport make lyophilization a suitable alternative to liquid formulations, especially for highly thermolabile products and live virus vaccine products. 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
The lyophilization process involves freezing and then performing primary and secondary drying under vacuum. The drying process itself presents a range of additional challenges. In order to solve these problems, some specific excipients must be added, including:
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During freezing, the vaccine components will be denatured, either in the freeze-concentrate state, at frozen surface interfaces and/or through cold-denaturation. Therefore, the effects of local concentrations of salts and buffers must be adequately considered. The concentration of oxygen captured during the freeze concentration state should be increased. |
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The pH change due to buffer crystallization must be taken into consideration during the formulation space of the lyophilized product. In the appropriate pH range, citrate, Tris and histidine are good choices for buffers because pH changes are minimal during freezing. |
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In addition to the cryoprotectants, other stabilizers may be required, which are known as lyoprotectants. For example, sorbitol is thought to be a good stabilizer in liquid pre-formulation. However, sorbitol is not preferred in dry formulations due to its low glass transition temperature. The two key attributes of lyoprotectants are high glass transition temperatures to minimize molecular mobility while retaining the native state in the dried state by serving as a good ‘water substitute’ (e.g. sucrose, trehalose). In addition, the use of reducing sugars, such as lactose, must be clearly weighed in the risk assessment strategy. |
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Bulking agents need to be added to the lyophilized product to prevent the "blowout" of the low concentration product (≤ 1% solid), in order to increase the product collapse temperature and improve product elegance. The excipient can be used as bulking agents or crystalline bulking agents. |
Salts and Buffer
pH
Lyoprotectants
Bulking Agents
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.
All of our products can only be used for research purposes. These vaccine ingredients CANNOT be used directly on humans or animals.
