High-quality CMC (Chemistry, Manufacturing, and Controls) documentation is essential for product out-licensing or sale. Consequently, biotechnology companies focused on out-licensing or selling a biologic must ensure that their CMC documentation satisfies the quality requirements for due diligence and transaction completion. Large companies’ acquired or in-licensed promising candidates must be capable of being developed into a commercial reality within a defined budget without scale-up and manufacturing delays. Therefore, your production strain and bioprocess’s ability to scale up in a reliable, consistent, and economically efficient manner, with the freedom to operate and adequate patent protection, is essential for successfully for completing acquisition or in-licensing transactions of biological products.
Delegate and rely is not a viable strategy for transaction success
The specialist nature of strain development means many companies outsource this function to CDMOs with experience in this area. The resultant strain is typically used for pre-clinical and early clinical batches and forms part of the proposed product package for any transaction. In many cases, the strain is fit for purpose and, with the standard stability testing and bioanalytics, will sail through due diligence. However, in other circumstances, the strain may present significant manufacturing challenges, and even if your clinical data delivers on its promises, you find the promising product failing due diligence and losing its value because the manufacturing process is not economically viable or fit for purpose. You may already be aware of flaws associated with your production strain, or they may come as an unwelcome surprise during scale-up. Either way, such flaws can have catastrophic consequences especially when it is too late to make amends and rescue the transaction.
Don’t wait until clinical development is imminent
The development plans for your product typically have tight deadlines and budgets; consequently, extensive re-engineering of the manufacturing strain once in or approaching clinical development may not be a viable option. This is especially true when existing market solutions based on traditional step-wise genetic engineering solutions do not have the capabilities to resolve the faults quickly or at an acceptable cost.
However, using full genome optimisation technology, creating a bespoke strain to resolve such issues is relatively straightforward. It can be achieved without disrupting your development activities or blowing the budget. The process is relatively affordable and fast to deliver a bespoke strain tailored to overcome the flaws in your existing strain. Notably, the bioprocessing challenge you encountered is, by definition, likely to be a non-standard issue specific to your protein product. Such non-standard protein specific solutions are generally novel creating IP that forms a formidable deterrent to competitors considering entering or eroding your market.
Funds allocated to resolve issues using QTL technology are spent in transparent stages agreed upon at the outset. A CMC regulatory submission with bridging studies allows the strain to be substituted for your existing strain retrospectively within your development timescale. Alternatively, it can be added to your licensing/sale package to mitigate risk alongside an existing production solution, giving the acquirer/licensee the choice to undertake such a bridging study CMC submission to switch strain.
This parallel approach will significantly enhance the attractiveness and value of licensing deals, potentially making the difference between a transaction completing or failing in due diligence.
