Lamark would be a global pioneer in breaking cold chain dependence for Insulin. We are a biotechnology company focused on R & D that develops thermostable Biologics, which are multifold stable formulations of existing biologics. The company has generated proof of concept analytical and preclinical data with its proprietary technology (patent filed) for rHI. The technology is being used for 4 other proteins and is sought by my collaborators for various applications. Our team is working in collaboration with pharma companies, academic laboratories, and government agencies to create thermostable and cost- effective biologics.
Protein engineering and chemical post-modification are commonly used technologies to improve the stability of therapeutic proteins. These techniques are effective but frequently reduce the protein activity, promote non-specific interactions, or give rise to new molecular entities. Crystallization is a logical solution, it preserves the structure, bioactivity, and pharmacodynamic profile of the protein. However, these crystals are less stable in a dry state, thus stored as solutions at low temperatures. To overcome this limitation, we developed a new method-based crystallization in hydrogels (patent filed).
The hydrogels positively influence the physicochemical properties of the resulting crystals and improve the pharmacokinetic profiles of proteins.
Hydrogel composition comprising pharmaceutically active protein crystals grown in-situ, such as insulin, within the hydrogel, provide several significant advantages to the crystals such as greater stability and controlled liberation. These Insulin crystals are bioactive, free of toxic additives, and compatible with subcutaneous administration, which has a narrow size distribution of 10 percent and acceptable pharmacokinetic profile.
- Biosimilar Formulations for temporal and thermal stability of biologic : Lamark, thanks to the aforementioned technology we develop thermostable biologic, like Insulin Strong which has significantly higher shelf life at room temperature. But the formulation does not alter pharmacological properties and the clinical component is unaltered. The molecule will benefit from Biosimilar/Follow-on drug route for faster and low-cost development.
- Novel biologics with improved pharmacodynamics : As mentioned, the technology can also control the release profile of the drug. Lamark team plans to create better pharmacokinetic profiles like ultra-long glargine; basal insulin which requires 1 injection per week. Adjuvant free Vaccines, Ultra-long Glargine are some of the product lines Lamark is pursuing in this business line. Longer development time and higher regulatory compliances are central challenges to this business line. Better differentiation and safety from intellectual properties; this business line expect higher risk and higher return. Further Lamark plans to create a third line of revenue by selling non-clinical grades of under development molecules by exploring their uses in research, diagnostic, and food industry