Value Proposition of Integrated ADC Manufacturing Processes – Use of Economic Modelling-Poster will be presented at PEGS Boston 2019 , April 8-12.
Development and manufacture of biologic-drug conjugates involves a complex supply chain of multiple, different specialised contracted cGMP facilities. CDMOs have simplified project & contractual arrangements either by forming supplier collaborations or by acquiring specialised facilities (“One-Stop Shop”). However, multiple facility transition steps remain, potentially with intercontinental shipments involved.
We have modelled the typical ADC process/supply chain with an industry-standard modelling template (BioSolveTM) to assess the economic value of integrating the downstream processing of the biologic with the drug conjugation processes. A useful process technology employed is Lock Release conjugation which has the potential to purify and conjugate a biologic, thereby acting as a link to integrate both processes. A fully disposable flow path operated in a multiproduct facility was modelled with supporting information from our own facility build and operational costs. The integrated process eliminates formulation & stability studies, repeated QC analytics, separate scale-up studies & contingency runs, etc of the biologic drug substance. The associated direct costs of these activities usually subsumed into the biologic API cost and represents the main cost savings; corresponding to 30-50% saving in ADC cost of goods, $/g, across multiple process scenarios. Additional 10-14% savings are seen through an overall decrease in the number of unit operations (yield increase) and a reduction of consumables required (10kg ADC campaign scenario). Perhaps most importantly, the overall project time from master cell bank to preparation of Phase I material could be reduced by 6-9 months.