Recombinant Albumin
Albumin is recognized by the healthcare industry as one of the main proteins present in human blood plasma and has been used widely for the formulation of complicated biopharmaceutical products over the years. Albumin has a wide range of applications across the healthcare and life sciences industry and related research. It is used as an excipient for vaccine manufacturing to minimize adverse effects arising out of temperature changes, environmental stresses, and any other substantial strains. As a reagent, it is used in cell culture media for facilitating the growth of many types of cells (like mesenchymal stem cells (MSCs), Embryonic stem cells (ESCs), induced pluripotent stem cells (iPSCs), T-cells, and immune cells), Invitro fertilization, cryopreservation, Diagnostic kit manufacturing, and medical device coating. There is growing research for maximizing its benefits for therapeutic use for the treatment of liver cirrhosis, hypovolemia, shocks & burns, dialysis, and pregnant women with low protein levels.
The drug developers and life science industries across the world for the longest time have used plasma-derived albumin (HSA) for the above-mentioned end uses, because of its stabilization properties and its ability to distribute a variety of endogenous and exogenous ligands. However, albumin derived from human blood plasma has been associated with risks such as contamination, impurities, presence of pathogens, and shortage of supply.
Over the years, with advancements in the field of biotechnology, increased research and developments in stem cell therapies, and significant push from the International governments for overall healthcare safety, there is a noticeable shift in the industry towards safer and reliable alternatives using Recombinant DNA technology.
Recombinant Albumin can be manufactured using a variety of hosts namely- plants, insects, molds, yeast, bacteria, and mammals. At Lazuline, our scientific experts using the rDNA technology have developed and manufactured rHSA using Pichia Pastoris as the expression host, which belongs to the yeast family. The choice of this expression system is a result of an experienced team of scientists with deep knowledge about different protein capture methods, and an understanding of the importance of Pichia Pastoris for appropriate folding and secretion for protein production. Furthermore, the production of endogenous secretory proteins is limited with yeast and hence simplifies the purification process of recombinant protein. It is also recognized as a unique host for the expression of subunit vaccines and is easy to use with well-defined process protocols. Maximum production of the target proteins can be achieved through some degree of process optimization. Overall, it is an efficient expression system to enable large-scale production.
Understanding Lazuline’s Yeast-based Albumin (rAlblaz): Safe, reliable, and sustainable
Lazuline, with its strong in-house R&D, access to world-class technology, cGMP manufacturing plant, driven by a dedicated team of professionals with new product development capabilities, has developed animal component-free and serum-free Recombinant Albumin (branded as rAlblaz) that is structurally equivalent to traditionally used Human Serum Albumin sourced from human blood.
rAlblaz, our Recombinant Albumin, is manufactured using the most advanced Pichia Pastoris expression system and is a preferred choice due to its high protein purity (>99% by SDS-PAGE and RP-HPLC), stability, and batch-to-batch consistency. Being animal origin-free, rAlblaz is free of endotoxins as well. The product is available in customizable protein concentrations (5%, 10%, 20%, and 25% solution) in liquid or powder form and Lazuline is ready to supply in large quantities for all end-users in the world market. It is also tested for long-term storage under defined conditions.
At Lazuline, we have carefully devised methods to enhance the functional properties inherent in albumin. We have successfully established manufacturing processes, analytical methods, QA/QC systems over several years of our development activities. Manufacturing of rAlblaz happens in a highly sterile environment that ensures the timely process of protein capture, intermediate purification, and appropriate polishing steps. Additionally, our integrated facility allows testing of rAlblaz on cells before supplying to end-users, ensuring a high success rate.
While it is comparable to the best in the world in terms of quality, with a large manufacturing capacity, Lazuline’s rAlblaz has become a cost-effective option compared to its global competitors, as it can offer the benefits of economies of scale and result in a reduction in per-unit cost.
Biosimilars: A broader perspective
While on a sectoral or patient level, the benefits of recombinant albumin for the formulation of challenging drugs and therapies cannot be overemphasized to that of traditional treatment methods that come with associated risks and disadvantages. Increased education has raised awareness and is one of the crucial factors contributing towards generating trust and acceptance for biosimilars.
The invention of biosimilars seems to be benefitting from an economics and healthcare standpoint. From a macroeconomic perspective, the governments are recognizing the key role of biosimilars in improving the access of patients to advanced therapies and its long-term benefits for tackling the escalating cost of healthcare. Research suggests that globally at the regulatory level, the confidence regarding the safety, quality, reliability, and efficacy of chemically defined components has been established.
With increased research collaborations and ease of investments for Research & Development from different parts of the world, there has been many advancements in various stem cell-based therapies, leading to a surge in demand for reliable components. Added to that, the uptake of biosimilars seems to be a result of specific factors such as incentives, policies, demand, and better access to resources and technologies. Lazuline being an Indian company, has access to global research collaboration while benefiting from lower manufacturing costs, there by offering the best of both worlds to its customers.
Authors:
Dr Ramesh Bhagam
Vice President-Quality Control at Lazuline Biotech
Bhavana Dandamudi
Marketing Analyst at Lazuline Biotech
