As cell and gene therapies become more complex, so do the legal implications of using key raw materials. Often, sponsors have two choices when accessing technologies such as cloning backbones, helper plasmids or CRISPR enzymes — they can create and license their own or use an existing licensed product.
Both options require a complex and costly intellectual property (IP) workflow. If you create your own materials, you’ll need to establish a patent and maintain it. Or if you acquire a licensing agreement, you’ll need to pay royalty fees based on volumes sold. Either path might require expensive consultations with attorneys — and added responsibilities for internal staff — to sort out patent protection or use of licensed products, which can drive unpredictable costs and legal fees, frustrate investors, and delay speed to market.
But there is an alternative. Sponsors have an opportunity to buy off-the-shelf (OTS) products from supplier-partners such as Aldevron, which, in turn, pay royalty fees directly to the IP owners. With this model, patented materials function as royalty-free products — you buy the ware at a flat-rate price, in whatever quantity you need, whether research- or GMP-grade — without worrying about the paperwork or fees typically associated with such products. Those processes occur in the background and are managed by the vendor, not the sponsor.
Furthermore, these OTS options save valuable time, critical in the current competitive environment to develop and reach the market quicker. Here’s what sponsors can now get off-the-shelf that come with these simplified royalty arrangements and why working with a consultative supplier-partner such as Aldevron is beneficial:
In this recent competitive market, mRNA programs have gained momentum — with some of the hottest applications being for vaccines and self-amplifying RNA (saRNA) — and cloning backbones have grown in great demand.
After cloning client template into the backbone, supplier-partners can provide the service to store and produce cloning backbones at any time and quantity, relieving further burdens of negotiating license requests and costs of scaling up during program development. This, in turn, stands to create an expedited path to market with associated overhead reductions — critical advantages in an ultracompetitive field such as mRNA.
The market for adeno-associated virus and lentivirus programs is well-established and well-equipped to address the ongoing demand for helper plasmids and packaging plasmids. At the same time, just a few groups hold the majority of licenses for these materials, which requires having an agreement with those companies for every use. And that’s very much a barrier, considering how often these raw materials get used.
Buying OTS plasmids from supplier-partners that offer proven products, consistent pricing and IP-simplified inventory can save money, time and the hassle of working through these agreements. And if sponsors use these materials during the scale-up of their programs, they won’t have to rethink their supply chain and related legal implications midway through as volumes fluctuate.
Like cloning backbones, enzymes have grown in demand as popularity in DNA programs increases. And similar to cloning backbones and plasmids, purchasing enzymes from supplier-partners that assume the licensing responsibilities can potentially help accelerate speed to market while reducing costs and complexities.
Additionally, new industry collaborations are helping to license and expand the availability of cutting-edge materials to anyone in need of any quantity. For example, a recent agreement between Inscripta and Aldevron provides researchers access to the Eureca-V™ Nuclease, the wild-type MAD7™ CRISPR Type-V Nuclease, for clinical development to commercialization.
Having these and other innovative and high-quality enzymes available in IP-simplified formats means researchers can overcome the burdens of manufacturing and analyzing them in their product production. With these conveniences, raw materials become like a “grab-and-go” commodity.
Expediting innovation with standardized products
In this fast-paced market, biopharma companies are hungry for efficiency — and using off-the-shelf, standardized products that simplify otherwise complex concerns such as IP is an obvious path forward. With licensing taken care of, researchers and manufacturers can worry less about royalty costs, time and complexity and more about readying their innovations for the market.
However, there are many other advantages to using these standardized materials beyond just the IP. Other benefits to OTS products include facilitating IND approval with drug master files and reducing manufacturing time.
When you can buy materials at a flat price for exact quantities needed, it provides the ability to accurately predict costs and timelines as you scale, without needing to reassess operations midway through to commercialization.
So why wait? Consider how IP-simplified products can transform your speed to market. View Aldevron’s product portfolio to see what’s available on the shelf for immediate use.