Verta Life Sciences have helped Pharmaceutical and Biotech companies plan the successful launch of new products and the secure supply of existing products,

by developing and implementing robust sustainable Manufacturing Strategies that ensure sufficient capacity is in place to meet anticipated customers demand, and manage the risks associated with complex supply chains during the life cycle of a product.

We do this by taking a life cycle approach to manufacturing supply, allowing our clients to better understanding their customer demands, and answering such questions as:

  • How much should we make and when?
  • Where should we make it?
  • What technology is required to make it?
  • Do we have sufficient capacity or do we need to invest in more?
  • What is the estimated Cost of Goods?
  • How can we leverage our existing supply chains to make it cheaper or do we need to look at alternative suppliers?
  • How can we ensure continuity of supply?
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MANUFACTURING STRATEGY CASE STUDY
Issue

A not for profit Product Development Partnership (PDP) with product entering Phase II/III clinical trials wanted to establish the basis for the supply of product to meet the projected demand for clinical trials and launch.

Objective

Establish a manufacturing strategy to provide sufficient manufacturing capacity to meet projected demands at key stages of the product development pipeline, and be scalable to allow for launch in selected markets and eventually be the basis of global supply at a very low cost of goods.

Deliverable

Modeled the projected volume of product required to meet clinical trial needs.

Using worldwide population growth data, modeled projected demand for the product post approval based upon various launch and approval scenarios.

Established a Manufacturing Strategy that; identified the annualized demand for drug substance and drug product, the increases in batch size required to satisfy demand, and the capital investments required to establish sufficient capacity to ensure security of supply during clinical trials and eventual launch.

Gained Board endorsement for the manufacturing strategy.

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Through our understanding of the challenges and demands placed on the supply of pharmaceuticals, biologicals and medical devices, we help you develop and implement manufacturing and supply chain strategies that establish the secure supply of new and existing products by:

  • Planning the successful launch of new products.
  • Conducting strategic sourcing reviews, rationalizing supply networks and outsourcing manufacturing.
  • Conducting Due Diligence reviews of existing supply chains
  • Selecting the appropriate manufacturing and supply partners
  • Managing the transfer of technology and products globally.
  • Integrating suppliers and contractors into an efficient and cohesive supply chain.
  • Delivering real and sustainable reductions in cost of goods.