PROCESS OPERATIONS

LINKING DEVELOPMENT AND MANUFACTURING

Process knowledge and process design are central to Kymanox’s Process Operations services. We align our approach with the principles of Quality by Design and use professional project management methodologies. With expertise in upstream< and downstream bioprocessing technologies, we apply best practices for both the initial setup and ongoing management of process operations. Planning and risk management are employed early in the drug development program to avoid costly troubleshooting down the road. Our team has proven, successful experience in:

  • Technology transfer and scale-up for Phase III and commercial processes
  • Process troubleshooting and optimization
  • Process design from bench to commercial scale
  • Creation of upstream and downstream development strategies
  • Feasibility and business assessments including cost modeling
  • CMO person-in-the-plant representation
  • Resource, budget and capacity planning for development and manufacturing
  • Fast-track preparation and execution of cGMP campaigns
  • Planning and managing of clinical and commercial drug product supply chains
  • Process mapping and process modeling
  • PAT, Six Sigma, and LEAN implementations
  • Hands-on execution and supervision of start-up cGMP manufacturing
  • Technical and quality audits at prospective CMOs

SYNERGY WITH OTHER KYMANOX SERVICES

Kymanox has a 360° view of process operations; we augment our activities with the following capabilities:

INTEGRATING SCIENCE WITH BUSINESS AND COMPLIANCE

With a focus on cGMP-compliant and financially viable processes, Kymanox helps its clients avoid expensive and often irreversible missteps. Together with our clients, we help select the optimal processing methods, equipment and components from early development through commercial cGMP manufacturing.

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