A 503(B) compounder with facilities in the New England and Southern regions of the United States required help doubling manufacturing capacity to meet its Private Equity (PE) investors’ growth objectives. The client brought in Kymanox® to lead its Technical Operations and CAPEX program execution from strategy development and implementation planning at the C-suite level, to execution and change control management on the shop floor. Specifically, the client required support designing and managing the buildout, commissioning, and qualification of two new ISO 7 clean rooms for sterile and parenteral injectable manufacturing and general operations expansion at its two sites. Additionally, the client required technical operations and engineering support for six new automated processing machines, expansion of vaults for controlled substances, expanding controlled substance, regular, and finished goods product storage, and other continuous improvement support on packaging and labeling lines. Finally, the client required assistance for Active Pharmaceutical Ingredient (API) scaleup, facility shutdown project management and leadership, change control management, and process/facility validation. An undertaking of this size required an experienced and cross-functional team. Kymanox provided this expertise through our first subscription-based service model.

Challenge

Managing the client’s large CAPEX program, considering that the client had no internal engineering organization, was a massive undertaking as projects and changes affected every function within the company. The cultures and communication styles at the two operations sites were significantly different. Scope changes were a frequent occurrence and commercial challenges affected cash-flow constraints.

Solution

Communication and expectation management were the keys to success. The logistics and constraints of this project required an experienced and highly-organized project management team. The Kymanox team touched base daily throughout the project to align goals and next steps. Project differences between sites were addressed by frequent touchpoints to discuss site-specific priorities and issues with the client’s extended team and site leadership. Kymanox resources were adjusted as needed between engineering and validation subject matter experts (SMEs) to address changing project needs; these changes were effectively accomplished with the subscription-based service model.

Results

At the Southern facility, Kymanox helped this client complete construction for facility expansion and warehouse relocation. The cleanroom designs are 75% complete, and fabrication offsite has begun. Electricians are designing the cleanroom electrical service, generator, and UPS, and design of all remaining areas of the facility are underway. At the New England facility, the vault expansion is complete, the cleanroom design concept is 100% complete, finished goods storage expansion is done, and the finished goods refrigerated storage expansion is complete. Automation projects are well managed with positive feedback from company stakeholders and are tracking to timelines and budgets.