Stabilization and protection of biomolecules enables development of formulations that exhibit optimal product characteristics, increasing shelf life, reducing the cold-chain burden, enabling patient-centric routes of administration and reducing manufacturing bottlenecks.
Growing Need for Stabilization and Protection
All drug products and medical devices containing biologic drug substances — from traditional proteins and antibodies to advanced therapies — benefit when the stability of the biomolecule is enhanced.
Increasing the stability of the API enables product optimization with respect to storage and ease of use. Biopharmaceuticals that can be stored at room temperature do not require cold-chain management. Formulations that do not require lyophilization are easier to administer. Higher-concentration parenteral drugs are often viscous, making them difficult to deliver subcutaneously and subject to API aggregation. Avoiding these issues facilitates, alternatives to IV administration and extension of product shelf life.
LEUKOCARE’s SPS® Technologies
Our proprietary Stabilizing and Protecting Solutions (SPS®) formulation technology platform provides next-generation formulation technologies to increase the stability and protection of therapeutic proteins in dry and liquid formulations. The platform comprises two elements: a database of ~100 excipients approved for use in pharmaceutical formulations and a rational software- and algorithm-based approach to excipient selection.
The SPS® technologies allow consideration of the specific characteristics of the biologic and the target product profile. Unlike standard formulations that rely on 3–4 excipients, our algorithms allow us to evaluate the full design space with a far higher number of potentially applicable excipients for a given biomolecule type, resulting in a higher probalility of success.
The optimum combination (generally in the range of 5–8 excipients) is determined after considering factors such as whether the product should be liquid or dry, the relevant physical and chemical stresses and the major degradation pathways. The performance of proposed stabilizing formulations is then evaluated using appropriate analytical methods specifically developed for their characterization
Many Stability Issues Addressed
Increased stability of the biologic drug substance leads to preservation of functionality and extended shelf life. The entire formula is also better protected during processing and/or terminal sterilization with - or -irradiation or EtO if required. This is particularly relevant in the case of medical devices functionalized with biological compounds. In addition to increased drug product quality, SPS® technologies typically afford cost savings and enable reduced development times. They also allow the development of new, highly differentiated products that can extend the product life cycle and enable entry into new market segments.
Clients benefit from our standardized technology platform, which is readily adaptable for a range of products and formulations. Using this standardized platform allows a faster and more reliable approach, leading to shorter development times and a higher probability of success.
The SPS® platform has been applied to traditional and fusion proteins; antibodies and bispecifics; biosimilars; non-enveloped and enveloped RNA and DNA viruses of many kinds, including live viral vectors; and biofunctionalized medical devices.
Bringing SPS® Benefits through Strategic Alliances
Through a strategic alliance with Rentschler Biopharma, LEUKOCARE serves as the dedicated formulation development partner for Rentschler’s clients. Advanced formulation development activities are integrated into process development efforts from the start, so LEUKOCARE has access to information regarding the biologic of interest in possible target product profiles.
LEUKOCARE provides the downstream processing group at Rentschler with recommendations regarding buffer development and other aspects that might impact the purification process. Rentschler’s clients thus benefit from formulations with higher stability in less time.
While LEUKOCARE is a pure formulation developer with a strong background in protein and virus analytics, we recognize the positive impact that our formulation knowledge and expertise have and are working to identify opportunities to leverage this experience in other ways.
Two Focus Areas
LEUKOCARE is currently focusing on two core businesses — biopharmaceuticals and viral vectors, including live, infectious viruses used to transfect DNA or RNA into targeted cells. Newer biologics, such as bispecific antibodies and fusion proteins (e.g., an enzyme coupled to an Fc receptor), are even more likely to be unstable than traditional engineered proteins. All of these biologic drug substances present challenges that can be addressed using our SPS® platform. We also have extensive experience with the stabilization of live viruses and can provide solutions that enable stabilization for up to two years in liquid formulations.