Pharma Company Benefits From Reserved Capacity' Business Model In Strategic CMC Outsourcing Partnership

After successfully outsourcing an initial CMC project to Almac and being extremely satisfied with the level of service with regards to technical ability, communication and project management, the following year, the global big pharma company sought a more strategic CMC outsourcing partnership and established Almac as a preferred provider, placing 10 projects within 12 months.

At the start of the working relationship, projects were awarded in two stages with a proposal and timeline being issued to the client for each stage / RFP.

Stage 1 – Analytical method development and feasibility assessment

• Development of analytical methods
• DiC process development trials on Xcelodose

Stage 2 – Analytical method validation and GMP Manufacture

• Validation of analytical methods
• GMP clinical batch manufacture and release testing

Challenges

This transactional ‘Fee for Service’ business model presented a number of challenges for the client namely:

1. Necessary Xcelodose technology capacity being booked months in advance
2. Greater emphasis on long range forecasting to secure capacity which is difficult during early development
3. Reduced flexibility with regard to scope change

Solution

Having access to Xcelodose technology when needed was paramount so the client moved to secure capacity by utilising a ‘reserved capacity’ business model approach moving to a monthly fixed rate that underwrites the capacity commitment, guaranteeing:

• X1 Xcelodose 600s for 50 weeks /annum running on triple shift, 5 days /week
• Technical expertise including dedicated Formulation development, Analytical, Quality and Project Management support
• Flexibility to prioritise projects based on Client’s needs

Keys to Success

The key element to making the ‘reserved capacity’ business model a success was the establishment of dedicated teams on both the Almac and client side underpinned by strong project management. Setting out a defined Project Framework from the outset provided a clear understanding of each other’s procedures and working practices, and outlined expectations regarding documentation turnaround times. Fundamental to all of the above was clear and open communication with the dedicated teams having weekly telephone calls to discuss status updates; schedule changes and long-range forecasts.

Results

By utilising one of Almac’s flexible business models, our client partner was able to secure capacity on Xcelodose technology providing full flexibility of resource utilisation to meet any changes in demand for the development of their portfolio of early phase drug products.