InVitria’s products are recombinant proteins that are manufactured at its manufacturing facility in Junction City, Kansas. These products have many uses across the life science industry, including applications related to regenerative medicine, cellular therapy, biomanufacturing, vaccines, diagnostics and medical devices.
Dr. Randall Alfano joined InVitria in 2012 and now leads the product development team, where he utilizes his expertise in media design and optimization for biomanufacturing and stem/primary cells. Prior to joining the company, Dr. Alfano was the Process Development Manager for XBiotech in Austin, TX where he specialized in the development and optimization of the company’s cell culture processes in mammalian cells for cancer biologics.
I am honored to release this interview with Dr. Alfano, in which we explore the formation of InVitria, as well as its innovative product portfolio, mission, and future goals. We also explore trends occurring within the broader cell therapy industry. Enjoy learning about InVitria’s role in accelerating life changing medicines through its unique portfolio of blood-free components, supplements, and media.
Interview with Dr. Randall Alfano of InVitria
Cade Hildreth: What is your professional background?
Dr. Randall Alfano: I received my Ph.D. from Texas A&M Health Science Center College of Medicine in 2009. I was fascinated by cancer and the angiogenic process that fuels tumor progression. I ended up in Dr. Art Frankel’s lab, who manipulated bacterial toxins such as anthrax and diphtheria, to target these biological processes to inhibit or delay tumor progression.
This was my first introduction to recombinant protein production as these immunotoxins were produced in yeast and bacteria. Under the guidance of Dr. Jung Woo, a significant mentor of mine, I was able to learn and excel at yeast and bacterial fermentation. From there, I moved to a group in Austin, Texas who were manufacturing a monoclonal antibody in CHO cells to target the inflammatory cascade.
Here I was able to establish a design of experiment, DOE, platform for media and bioreactor optimization for mab production in CHO cells. This ultimately led me to be recruited by InVitria in 2012 as a cell culture scientist, where the focus was on reinventing cell culture media performance.
Cade Hildreth: How did you become involved with InVitria?
Dr. Randall Alfano: I found InVitria’s mission of removing blood-derived components from all cell-based manufacturing processes fascinating and wanted to be a part of that. In fact, I was an avid user of InVitria’s products during my time optimizing CHO media and bioreactor feed strategies. Coming from a CHO background, I understood the necessity of chemically defining cell culture systems and the benefits of removing all serum-derived components to maximize cell culture productivity and reproducibility of a manufacturing process.
Seeing that InVitria was leading this same movement in stem and primary cells, I knew I wanted to be heavily involved in contributing to this revolution in cell culture.
Cade Hildreth: When was InVitria founded and why?
Dr. Randall Alfano: This is a great question. InVitria was founded in 2008 with the goal to improve performance, consistency, safety and reliability of biologics made from cell culture, including vaccines, cell therapies, gene therapies, regenerative medicines and related products.
The use of serum and serum-derived components can hinder the translation of novel life-saving therapeutics from bench to bedside. The introduction of unacceptable variation into the manufacturing process, risk of adventitious agents, and poor control in the resulting expanded cell product phenotype all negatively impact therapeutics.
InVitria’s mission is to facilitate the approval of these life saving medicines through the enablement of unlimited scale, unrivaled safety and ultimate control of the manufacturing process through the supply of high-quality recombinant proteins.
Cade Hildreth: What are InVitria’s key product offerings for cell culture and biomanufacturing, and what differentiates InVitria from other cell culture companies?
Dr. Randall Alfano: InVitria offers a non-mammalian source of key cell culture media components like albumin, insulin, growth factors and transferrin. Not only are these products recombinantly produced, but they deliver consistency and supply reliability that is unmatched. Further, InVitria has expertise incorporating these components into complete and custom cell culture media formulations which are tailored to your cell type and manufacturing processes through a collaborative and transparent approach.
Cade Hildreth: What trends are you seeing within the cell culture market? What is the importance of blood-free components, supplements and media?
Likewise, MSC fail to expand in the absence of serum or serum proteins. Thus, cell culture manufacturing can be improved with the use of cell culture media optimized with blood-free components to expand these clinically relevant cell types and achieve the performance, safety, reliability and affordability objectives desired by developers and regulators.
Advances in recombinant protein expression has produced recombinant versions of serum albumin and transferrin that are both biologically active as well as economically viable due to their large-scale manufacturing capabilities. Incorporation of these highly purified recombinant proteins can produce media formulations that may simplify research and development through the higher degree of chemical definition via the deletion of human serum-derived biologically active contaminates or extremely complex mixtures of multi component-containing plant di and tri peptides or HPL.
This approach gives rise to the concept of blood-free media, in that the media formulation performance does not rely on poorly characterized multi-component complex mixtures and/or blood-derived proteins with uncharacterized serum contaminates.
The incorporation of these proteins can produce media formulations that may facilitate the regulatory approval process for clinical products due the absence of blood-derived components. More importantly, adoption of clean media may enhance the productivity of cell culture systems and thus give the operator a higher degree of control of the cell culture system. By excluding components that may blunt biological processes relevant for cell-based therapeutics manufacturing, differentiation or cell productivity can be better controlled.
Cade Hildreth: What types of clients do you serve and how do they use your products?
Dr. Randall Alfano: We serve clients that are early innovators beginning clinical phase all the way up to the largest biologics companies in the world. We also work with key scientific leaders developing the therapies of tomorrow.
Cade Hildreth: What are your five-year goals for InVitria?
Dr. Randall Alfano: Our vision is to provide the highest quality and best performing cell culture media formulations and supplements for cell therapy, gene therapy, vaccine, regenerative medicine and medical device customers on a global basis. On a global scale, we enable our customers to eliminate blood components from their cell-based processes, which improves consistency, safety and efficiency of their end products.
Cade Hildreth: How can people get it touch with you or InVitriato learn more?
Dr. Randall Alfano: We can be reached by phone at (800) 916-8311 or by email at Info@InVitria.com. Our products are available for purchase directly at www.InVitria.com. Also, our products are carried by the leading global life science distributors.
Do you have questions about InVitria’s vision or how they apply their products to your application? Ask them in the comments below.