A multinational client contracted KPC International to provide holistic services for the start-up of a new large API facility in the Caribbean. The existing manufacturing plant had significant challenges, and a project had been started to build a new bulk API manufacturing facility. Among the range of services provided was our Tech Transfer Program Management and Operational Readiness expertise. 

Project Scope 

The specific services provided by our Tech Transfer and Operational Readiness team on this project are as follows: 

  • Site evaluation for an existing and new facility with respect to all functional areas 
  • Gap Assessment and Risk Mitigation Plan 
  • Delivery of Strategic Start-up Plan for the new facility 
  • Development and implementation of Site Capital and Tech Transfer Program Management Process 
  • Guidance and support for Tech Transfer Program Master Planning 
  • Provision of resources in the following disciplines 
  • Automation 
  • Quality Assurance 
  • Documentation 
  • Tech Transfer Specialists 
  • Engineers 
  • Leading meetings, Risk Management Progress Reporting 
  • Provision of mentoring and guidance with respect to technical requirements 

Project Outcome 

In this project, the Site Evaluation and Strategic Start-up Plan identified the key areas of risk and their mitigations. The implementation of a solid Project Management philosophy for both Capital and Tech Transfer Projects gave the engineers and scientists a framework and process to enable effective planning, execution, monitoring and communication for these projects. A Project Management manual was delivered, and staff were trained and mentored.  As a result of the above services, KPC enabled the development of a cohesive and integrated project team, developed clear and efficient team structures and stimulated relationship growth between Sending and Receiving units. The success was the ability of the team to deliver PPQ batches, having dealt with significant engineering and scope changes as a result of environmental impacts 

Why work with KPC? 

At KPC, we are used to working with people from different cultures, different levels of expertise and different organizations. We understand the pride that clients take in their project or site and the unease outsiders can bring. That is why, on all KPC projects, we invest heavily in building strong relationships with our clients and stakeholders from the beginning. First, we listen. We take time to understand the people and what has worked well for them. We then share our experiences openly; we offer advice and guidance with an open mind, and then we build and implement the solutions needed to achieve success. This is the KPC-proven approach:  Discover, Define, Develop & Deliver. 

To learn more about our Tech Transfer and Operational Readiness services for the Pharmaceutical and Biotech industries, visit our services page here.