Applications for albumin are growing beyond the traditional cell culture and protein and peptide formulation to include delicate stem cell therapeutics and other biopharmaceuticals. Albumedix, the leading recombinant human albumin manufacturer, is directing attention to those new and emerging formulation challenges that require the sophisticated solutions recombinant human albumin can provide.
“As recombinantly-produced excipients, growth factors, modifying biologic agents, and cryoprotectants become the norm, drug developers need a controlled, consistent, reproducible media to ensure the purity, potency, and identity of therapeutic cells,” Jonas Skjødt Møller, COO, says. “This helps regulators focus on the therapy itself rather than potential effects of media variation or impurities.” Recombinant human albumin does that.
The need for a consistent, stable environment exists not just in the final formulation step, but throughout the drug development process. “Recombinant human albumin enhances expansion and improves the fidelity of transformation well before cryopreservation and final formulation,”Møller points out. Used early in the process, it confers those same benefits of process consistency, quality, and reproducibility, thus streamlining further development and scale up.
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The reason for those benefits, Phil Morton, CTO, explains, is that, “Recombinant human albumin is free of animal and human components that can cause variability in cell-based systems, so it provides regulatory benefits while protecting their microenvironment and improving cell viability. In manufacturing, it also enhances batch-to-batch consistency. Albumin supports growth, morphology, proliferation, reproducibility, and viability of cells after isolation. After cryopreservation, it supports cell viability and shelf life and potentially improves the efficacy of the cell therapy by improving cell quality.”
Albumedix is exploring the use of recombinant human albumin in several application areas, including stabilization of vaccines, cell therapies along with the more established area of protein and peptide therapeutics.
These advanced applications are based in part on research from the University of North Carolina, Morton says. “Recent research demonstrated that incorporating human serum albumin improved adeno-associated virus (AAV) vector transduction five- to seven-fold, resulting in a concomitant increase in expressed and active protein. Additionally, mechanism studies suggested that human albumin increased AAV vector binding to the target cell surface and resulted in faster blood clearance after systemic administration, but did not impact AAV infection pathway.
“Whether such vectors are used to modify cell therapies or serve as standalone therapeutics, the addition of albumin can dramatically improve the performance of the modified cells,” Morton continues. It’s unknown whether albumin will improve the performance of other viral vectors requires investigation, but “yeast-derived recombinant albumin would be preferable to human serum albumin (HAS) for such progressive technologies.”
A history of innovation
Albumedix has worked with albumin for more than 30 years. “Our products are used in biopharmaceuticals all the way from preclinical studies to marketed products. That gives us a unique and extensive knowledge base around this molecule,” Møller points out.
The company uses that expertise, gained by refining technologies and developing products, “to provide technical and regulatory support and thus increase our customers’ likelihood of success when they use our recombinant human albumin in the development of their biopharmaceuticals,” Møller says. For example, “The extensive regulatory package for our Recombumin® products is not available for any other recombinant human albumin on the market.” Consequently, this reduces the regulatory hurdles companies must overcome, allowing them to concentrate on other critical factors.
As the company continues to innovate, educating the scientific community about new and emerging uses for albumin is increasingly important. “We see a need to re-educate the market and address antiquated perceptions of human albumin to incorporate the more current discoveries and benefits of recombinant human albumin,” Møller says. Consequently, the Albumedix team makes it their mission to share knowledge that even great drug developers may be missing, to help them in their development of therapies.
Another example of how Albumedix has further optimized the unique properties of albumin is through its drug-enhancing Veltis® technology platform for advanced drug delivery. Albumedix modified the albumin molecule toextend albumin’s half-life beyond the usual three weeks and thereby increase the area under the curve for any drug attached, to carry larger payloads, and to tightly target specific tissues.
“Veltis® technology has great potential for the development of novel therapies with tailored delivery and improved therapeutic performance,” Morton says. “It displays an unprecedented affinity for albumin’s natural receptor, the neonatal Fc receptor (FcRn), thereby opening the possibility for monthly dosing, as well as novel delivery and targeting mechanisms.”
As Albumedix plans for the future, it focuses on innovation and expansion.In the near future, the company plans to invest further in its UK production facility and to increase its manufacturing capacity.
As the industry moves from traditional pharmaceuticals towards even more complex drugs such as antibody drug conjugates, gene therapies, and cell-based therapies, and the line between drugs and devices blurs, formulation challenges increase. “Recombinant albumin,” Morton says, “provides a solution for these more complex challenges.”
With that in mind, the company is keen to form additional collaborations. Albumedix already has strong relationships with many of the leading European universities. Now it wants to participate in even more strategic, innovative research collaborations and partnerships with industry as well as academia to “ensure more efficient and safer treatment for patients,” Møller says. Such collaboration may involve like-minded technology, drug, and medical device developers, as well as researchers at academic institutions. “In Albumedix, we are always seeking partners and collaborators to unlock the full potential of albumin.”
Research interests include the formulation and stabilization of vaccines, proteins, and peptides, and especially, the development of cell therapies. “Cell therapies and vaccine stabilization are areas in which we are seeing a lot of interest and growth,” Møller says. “We also are looking to explore partnerships for our Veltis® drug delivery platform, which is based on engineered human albumin variants. Our partnership with Novartis, evaluating enhanced delivery methods for first-in-class therapeutics, is one recent example. Together with our collaborators, we aspire to pioneer innovations within the field of albumin-enabled therapeutics through the commitment to better health.”
Meet Albumedix at BIO-Europe® 2018
Meet Albumedix at BIO-Europe in Copenhagen this November and attend their presentation to learn more about how albumin can affect the outcome of therapies and ultimately patient quality of life.