Proven Past Performance

$60+ Million USD Manufacturing Capacity Expansion Project for High-Volume, Sterile-Filled Medical Device

Kymanox involvement kept the program on schedule and within key budgetary parameters. Once online, the new state-of-the art facility cleared critical product backorders, reduced scrap, and eliminated the reliance on aging manufacturing technology.

Kymanox provided the overall, supervising, and PMP-certified Project Manager to oversee all construction activities, budgets, and CGMP manufacturing readiness. The Kymanox project manager facilitated key project decision making requiring expert level engineering analyses and managed facility, equipment, automation, and qualification efforts. Kymanox moderated supplier relationships for multi-million dollar equipment and CGMP system purchases.

Managed Global Supplier Qualification and Management Program for Large Biopharma Company

Kymanox support reduced the need for hiring dedicated auditors while the fixed-price audit model provided budgetary certainty.  Kymanox’s pool of ASQ certified auditors ensured audits were performed and finalized per SOP timing guidelines and met scheduling constraints imposed by suppliers.

In a multi-year program, Kymanox managed and executed more than 50% of all required supplier qualifications and maintenance audits totaling hundreds of audits across the globe. The scope managed by Kymanox included suppliers of raw materials, device manufacturing, sterile filling, bulk drug substance production, specialty pharmacy, warehousing, 3rd-party logistics, packaging, and labelling.

Facility Conceptual Design, Construction and Commissioning for $30 Million USD Multi-Purpose, Fill-Finish Facility

Kymanox functioned as the entire internal engineering group and provided Owner Rep leadership to design, build, and commission a modern sterile manufacturing facility that now functions as an important Contract Development and Manufacturing Organization (CDMO).

Kymanox led a make-vs-buy analysis and conceptual process design for compounding and filling of first-in-class parenterals. Kymanox provided owner representation support, overseeing all construction and commissioning activities. Kymanox was responsible for all master planning, authoring of requirements specifications, and procurement of equipment and key facility systems.

Validation Master Planning, Risk Assessment, Policy and Procedure Development, and Life Cycle CQV for Novel Drug Particle Manufacturer

Over a six year period, Kymanox provided on-demand validation support and expert guidance, as well as project management oversight, to qualify an entire facility to Phase IIb requirements.  As drug development progressed, Kymanox supported upgrades and expansions of the facility to meet all commercial CGMP requirements ahead of product approval.

Kymanox developed policies and procedures for initial commissioning, qualification, and validation activities for custom production equipment, lyophilizers, environmental chambers, cleanrooms, computer systems, and clean utilities. Kymanox authored Standard Operating Procedures (SOPs), Validation Master Plans (VMPs), test protocols, and final reports. A vast majority of Kymanox’s work was delivered on a fixed-price, fixed-scope basis and done in a competitive procurement process with a 100% win rate.

Kymanox Implemented PMO System at $500 Million USD Global Excipient Manufacturing Company

To help usher in a new corporate culture and provide enhanced communication and efficiency on business execution, Kymanox was engaged to build a Project Management Office (PMO) from the ground up using Kymanox’s own PMO Toolkit.  In less than a year, the new system transitioned the company to a successful matrix-based execution model; KPI trending showed a positive return on investment within this short period.

Kymanox developed customized policies, procedures, and templates for initial Project Management Office deployment.  Kymanox trained 30 global employees on the new PMO system and provided two project management resources for initial pilot projects. Kymanox also defined roles, recruited, and assisted with initial hiring of PMO staff.

Provided Expert Guidance and Management of PAI Readiness for Two Orphan Combination Products

Kymanox leveraged detailed product and process knowledge gained from earlier engagements at the same client to help author two Biologics License Applications (BLAs) submissions and prepare for the subsequent Pre-Approval Inspections (PAIs).  The company had successful back-to-back FDA product approvals which led to a $5+ billion USD acquisition immediately thereafter.

Kymanox provided Project Management, managed FDA regulatory meetings, qualified entire commercial supply chain, performed mock PAI audits, supervised and summarized all process validation and stability programs, and authored CMC section of combination product submissions (i.e., BLAs). Kymanox formulated responses to FDA questions related to bulk drug substance manufacturing, drug product manufacturing, and the multi-use autoinjector device.

Addressed New FDA Requirements for Emergency Medical Devices Requiring Advanced Reliability Performance

In a new regulatory environment that was seeing enforcement action, but without any published industry guidance, Kymanox developed a novel and holistic approach to address reliability requirements that guarantee emergency devices work at least 99.999% of the time.  The immediate benefit of Kymanox’s work resulted in savings of over $30 million USD.

Kymanox evaluated FDA enforcement requests for engineering, Quality Control (QC), and Quality Assurance (QA) improvements. The expert team overhauled risk assessment techniques, sample plans, manufacturing control strategies, analytical test methods, and Quality-by-Design (QbD) approaches to meet all regulatory concerns and improve reliability assurance with additional cost savings related to sampling and sample analysis. Kymanox employed advanced statistical techniques to deliver project success and help avert a national drug shortage.

Under Consent Decree Supervision, Validated Entire Asset Portfolio of Automated Drug Product Filling Equipment for a $3 Billion USD Manufacturing Division

Working on-site at four manufacturing locations in the United States, a large cross-functional team from Kymanox quickly assessed and remediated critical drug product filling equipment, including its automation.  The speedy and “Right First Time” (RFT) work helped avoid imminent drug shortages at US hospitals.

Working with organization’s Quality Unit, supervising FDA Expert Consultancy, and responsible Consent Decree remediation law firm, Kymanox analyzed production equipment performance and automation controls to provide recommended remediation for full CGMP compliance. With a large team working in parallel, Kymanox quickly completed engineering studies, commissioning activities, and full validation to restore equipment to CGMP production.