From off-the-shelf proteins to custom protein products, in partnership with R&D systems, we have high-grade project-specific solutions.
From our R&D systems portfolio, we have more than 5,000 different off-the-shelf research grade proteins and good manufacturing (GMP) proteins for clinical applications. We also offer robust custom services where we take custom projects from a variety of pharmaceutical companies, biotech, and academia. We can drive manufacturing of some of the most challenging proteins on earth, and that's what we pride ourselves in: making proteins that others have failed to make.
R&D systems brought their first recombinant protein, interleukin 2, to market in 1988. The director of molecular biology department has been making proteins for 33 years. They have some of the best protein biochemists on earth in their protein purification department; they have seen it all and have good strategies for overcoming challenges. They also work with state-of-the-art infrastructure for doing side by side clone screening that allows them to pick clones and plasmids for transient production that gives high levels of expression and secretion of the proteins. So, it comes down to their experience. They have been making proteins longer than most other companies, and that rich history allows them to succeed where others have failed. In vitro Technologies take pride in associating with such a brand to enable their services in Australia and New Zealand.
What is the process for making custom protein?
Generally, a customer will post an inquiry through our custom services form on our website. Then the respective Territory Managers initiate a conversation to understand the customer's needs. From there, the project moves to our technical team, where we put together a statement of work with gated timelines. From there, we work with R&D systems to test if they can express the gene of interest in various host systems and send the customer a sample of the protein at a small scale to test in their applications. If the customer approves, then we request scale-up and provide mass quantities of the protein for their work. When we launch custom projects, we work with confidential information. We do not share this with anyone besides the customer; we take that very seriously.
The first step in scaling up is to optimize production at small scale for high yields. We work with R&D systems to optimize expression levels and the amount of protein secreted from the cells in a mammalian system. Or if the protein is in E.Coli, we work to optimize expression in refolding process at small scale. It all depends on the needs of the customer. R&D systems has capacity to scale production of mammalian and E. coli-derived products well into the gram levels if needed for the customers downstream applications.
Does In vitro Technologies provide project management for protein production?
The same experts at R&D systems that make our off-the-shelf products are involved in custom workflows. That is the beauty of it; we get on the computer or the phone and interact directly with our custom clients and our technical leaders. Our customers get the best interaction on these custom jobs. We handle it all internally, bringing molecular people, purification people, cell culture people, and whoever from R&D systems we need, to into the meetings to make sure all relevant information is conveyed.
What GMP services do you offer?
Our customers use GMP proteins as ancillary materials for clinical applications, and they deserve a consistent supply of high-quality proteins with minimal lot-to-lot variability. We provide complete documentation of how our GMP proteins are produced and how they perform in quality control testing. Whenever possible, our GMP proteins are produced under strict animal-free conditions including all materials, equipment, dedicated laboratories, and documentation. Of course, the Quality Team ensures compliance with all relevant guidelines from governing authorities.
What is an important, but often overlooked aspect of protein production?
Protein stability and formulation are important. Quite a few of our competitors will get proteins to the market fast, but if we look at them from an analytical perspective, they are not very stable proteins. They are formulated in buffers that are not amenable to long term stability, freeze thaw stability, or four-degree stability. That is something that a lot of people do not put a lot of thought into. Formulation and stability testing are critical for high quality products. In association with R&D systems, we pride ourselves on having world class bioassay capabilities to make sure our proteins are the same lot-to-lot. They are stable over time; they will not fall out of solution if researchers freeze and thaw them or store them at four degrees Celsius for extended periods.
