March 1, 2017 (Vol. 37, No. 5)
Interview with Michael Scholl, CEO of Leukocare
Leukocare is a privately owned, product-focused, clinical-stage biotechnology company founded in 2003 and headquartered in Martinsried/Munich, Germany.
The company has been funded since its incorporation by a group of private investors. In 2006, the German state-owned bank KfW invested into Leukocare through its equity-program ERP-Startfonds.
Leukocare is widely known for its proprietary SPS® formulation technologies and GEN recently interviewed Michael Scholl, CEO of Leukocare, to learn more about the company’s SPS platform.
GEN: Please describe your SPS (stabilizing and protecting solutions) technology platform, including what it is used for and for which applications in the pharma and biopharma production of drugs.
Mr. Scholl: SPS technologies represent a next-generation formulation technology platform for the protection of proteins like biopharmaceuticals to enable the development of better products. SPS are offered to development projects of partners in the pharmaceutical and medical device industries. In particular, Leukocare’s SPS formulation technologies improve stability and quality of biologics (like antibodies; including high-concentration formulations) and vaccines (including live viral vectors; in liquid and dry formulation) and protect proteins in biologically functionalized medical devices (including apheresis columns, implants, and wound dressings) during terminal sterilization.
GEN: What ingredients or compositions go into making the SPS platform?
Mr. Scholl: Leukocare’s proprietary SPS formulation platform is based on a library of approximately 100 different pharmaceutical excipients that are all well-known from a regulatory perspective. Most are listed as inactive ingredients and all are listed in pharmacopoeias of important regulatory regions, e.g., U.S., EU, Japan, etc. Different natural amino acids comprise the largest group of the platform.
Each SPS formulation is comprised of 5–8 selected excipients and is adjusted to the specific needs of the target molecule to be formulated. SPS formulations are suitable for both liquid and dry formulations and provide low cost of goods and superior protection and stability.
GEN: You mentioned that SPS is available in both dry and liquid formulations. What are the different applications for each formulation?
Mr. Scholl: Liquid formulations are more cost-effective than dry formulations since no lyophilization/spray-drying step is needed. In addition, they provide enhanced convenience for medical doctors and patients since they do not have to be reconstituted but can be directly administered.
Dry formulations on the other hand provide stability superior to liquid formulations and the option to be terminally sterilized. However, a lyophilization/spray-drying step is needed during production and they usually have to be reconstituted prior to use.
GEN: What is SPS’ mode of action?
Mr. Scholl: The mode of action depends on the type of formulation (liquid or dry). In liquid formulation, appropriately selected SPS excipients are purposely excluded (preferential exclusion). Water-protein interactions are stronger than SPS excipient-protein interactions, resulting in a stabilizing hydration of the protein. The hydration shell prevents interaction with co-solvents, resulting in increased stability of the target protein.
In dry formulation, appropriately selected SPS excipients replace water and build hydrogen bonds and other non-covalent interaction with the target protein (water replacement). As a result, an amorphous shell is formed which protects the protein’s 3D structure from, e.g., aggregation or unfolding.
GEN: What are the benefits of using this technology?
Mr. Scholl: The SPS formulation technology platform provides best-in-class stability. It allows the development of pharmaceutical formulations in a shorter period of time, mainly driven by the SPS-database, the focused design of experiment approach and the know-how of Leukocare. This results in reduced costs, shorter time to market, and a much higher probability of success in developing pharmaceutical formulations meeting defined objectives.
In addition, SPS formulations can be patented and provide freedom to operate. Infringement of existing formulation patents can be avoided, which is often important in the development of biosimilars.