Patent thickets are critical to biosimilar development
The market potential of new indications for existing biologic therapeutics can be held back by technical challenges arising from the need for higher titre, reduced downstream processing and consistent, high quality protein. These issues become critical when the scale of the new indications exceeds the original use.
But recent advances in bespoke multi-parameter optimisation have overcome these technical obstacles. So now QTL-enabled recombinant protein projects have a bigger opportunity within their grasp: creating valuable extra layers of patent protection to shut out competition.
Old processes for new indications lead to cost and delay
Solving a medical problem using a regulated substance with a known safety and tolerance profile has numerous advantages that include lower risks, costs and timeframe of development. But, there is also an opportunity to upgrade the entire manufacturing process to deliver biosimilars at more affordable prices while also dominating the market.
Sometimes existing strains and manufacturing methods require substantially more plant to deliver new indications. This drives the cost of goods higher in the form of depreciation, maintenance, staffing and overheads. Building new capacity and obtaining regulatory approval causes delay. The need for clunky and inefficient downstream processing can also raise the risk of problems, inconsistencies and a substantial loss of yield. It simply isn’t competitive to use the original decades-old manufacturing process for biosimilar markets.
Investors worry about scale
While contract manufacturing organisations are often hired to produce batches during clinical development, they can’t always deliver commercial scale production. Bringing a biologic product to market is an expensive and time-consuming business, so finding yourself unable to meet customer demand while your patent protection lifespan is slipping away is a situation to avoid at all costs.
That’s why sticking with an old-fashioned manufacturing approach can fatally undermine the feasibility of – and investors’ appetite for – even the most promising recombinant protein project. The risks are perceived as too high, and the timelines too long.
Optimisation enables tailored and market-ready solutions
Whether you are upgrading your original manufacturing process or bringing a biosimilar to the market for the first time, there is a need to optimise some aspects of the manufacturing process. QTL technology resolves these concerns by means of multi-parameter optimisation that unlocks the full power of biology to capture market share, whatever your position. It provides first-movers with added patent protection that makes their product less vulnerable to would-be competitors – and extends that protection over a longer period.
The patent protection delivered by QTL technology covers all the genomic variations necessary for any strain to deliver the attributes for successful manufacture. It’s a formidable tool that brings customised and market-dominating advantages to products.
That’s why it pays to have QTL technology on your side, not theirs.