30 The manufac f ture of our product candid d at d es t is high i ly complex e and requires substantia t l lead time to produce.e Manufact f ur t ing our product candidates involves complex processes, including developing cells or cell systems to produce the biologic, growing large quantities of such cells, and harvesting and purifyi f ng the biologic produced by them. These processes require specialized facilities, highly specific raw materials and other production constraints. As a result, the cost to manufact f ur t e a biologic is generally far higher than traditional small molecule chemical compounds, and the biologics manufac f turing process is less reliabl a e and is difficult to reproduc d e. Because of the complex nature of our products, we need to oversee the manufact f ur t e of multiple components that require a diverse knowledge base and specialized personnel. Commercial manufac f turing scale-up timelines may be negatively affe f cted by material shortages, construc r tion delays and suppl u y chain challenges due to, among other factors, global suppl u y chain shortages due to health epidemics, on-going geopolitical conflic f ts, global macroeconomic conditions, bank failures or other reasons. Moreover, unlike chemical pharmaceuticals, the physical and chemical properties of a biologic such as our product candidates generally cannot be adequately characterized prior to manufac f turing the final product. As a result, an assay of the finished product is not sufficient to ensure that the product will perform in the intended manner. Accordingly, we expect to employ multiple steps to attempt to control our manufact f ur t ing process to assure that the process works, and the product or product candidate is made strictly and consistently in compliance with the process. Manufact f ur t ing biologics is highly susceptible to product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, improper storage or transfer f , inconsistency in yields and variability in product characteristics. Even minor deviations from normal manufact f ur t ing, distribution or storage processes could result in reduced production yields, product defects and other suppl u y disrupt r ions. Some of the raw materials required in our manufac f turing process are derived from biological sources. Such raw materials are difficult to procure and may also be subj u ect to contamination or recall. A material shortage, contamination, recall or restriction on the use of biologically derived subs u tances in the manufactur t e of our product candidates could adversely impact or disrupt r commercialization. Produc d tion of additional drug r subs u tance and drug r product for any of our product candidates may require subs u tantial lead time. In the event of significant product loss and materials shortages, we may be unabl a e to produce adequate amounts of our product candidates or products for our operational needs. Further, as product candidates are developed through preclinical studi t es to late-stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufact f ur t ing methods, are altered along the way in an effo f rt to optimize processes and results. Such changes carry r the risk that they will not achieve these intended objectives, and any of these changes could cause our product candidates to perform differently and affe f ct the results of planned clinical trials or other future clinical trials. We rely on third parties for raw materials needed for manufac f turing our product candidates. We may not be able to obtain adequate amounts in the future. These challenges are magnified by the international nature of our suppl u y chain, which, for tarcocimab a and KSI-501, requires drug r subs u tance and drug r product sourced from single source suppl u iers from China, Japa a n, the United Kingdom, the United States and Switzerland. We have limite i d expe x rience manufac f turing i any n of our product candid d at d es t at a commercial scale. l If we or any n of our third- party manufac f turers encounter t diffi i cultie t s in productio t n, or fail to meet rigor i ouslyl enfo n rced regu e latory stan t dards,s our abili i ty i to provide d suppl u yl of our product candid d at d es t for clin l ical trials,s or our ability i to suppl u yl our productst for patie t nts, t if approved,d couldl be delayed a or stoppe t d, or we may a be unablel to establis l h a commercially viablel cost stru t cture. In order to conduct clinical trials of our product candidates, or suppl u y commercial products, if approved, we will need to manufac f ture them in small and large quantities. Our third-party manufac f turer has made only a limited number of commercial scale lots of tarcocimab based on our ABC Platform. Our manufac f turing partners may be unabl a e to successful f ly increase the manufac f turing capacity for any of our product candidates in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up activities. If our manufact f ur t ing partners are unabl a e to successful f ly scale up the manufact f ur t e of our product candidates in sufficient quality and quantity, the development, testing and clinical trials of our product candidates may be delayed or become infeasible, and regulatory r approval or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business. The same risks would apply to any internal manufac f turing facilities, should we in the future decide to build internal manufact f ur t ing capacity.