Three reasons continuous manufacturing can deliver innovation and agility to help transform the pharma industry

13 November 2020

by Scott Mahoney Principal at PwC Management Consulting, PwC United States

+1 617-306-8718

Imagine a world where…

  • a 10-fold spike in product demand can be met at a moment’s notice, anticipated by artificial intelligence (AI) and automated into manufacturing and distribution;
  • the supply chain can be streamlined to manufacture products in the most efficient way possible, at the minimum cost, at the right location and time, and with minimum levels of safety stock;
  • production facilities can be made 10 times smaller, relocated overnight, validated as quickly and then operated with minimal human interaction;
  • quality can be predicted, verified and traced in real time to minimize waste and maximize safety to the patient whilst releasing batches in real time.

An industry lagging behind the field

Over ten years ago, we released a report highlighting the need for the pharmaceutical supply chain to innovate and overhaul in order to meet future demands. Since then, the world of healthcare has advanced, yet manufacturing and distribution in pharma has lagged significantly behind other areas in the healthcare value chain, and especially when compared to high performing non-healthcare industries (such as Fast Moving Consumer Goods and automotive) who have implemented innovative technology solutions that deliver significant business and customer benefits.

The traditional batch manufacturing method for pharmaceutical products plays a part in constraining the supply chain, preventing progress through a multitude of constraints (eg lengthy lead times, fixed batch sizes and manufacturing locations etc).

A fundamental enabler to future improvement

Use of continuous processing enables pharmaceutical supply chains to take advantage of significant innovations commonplace in most other industries. Adoption of such a capability will provide benefits in three key areas:

1. Flexibility to manufacture just about anywhere

Up to an 80% decrease in the required footprint of continuous unit operations enables the mounting of manufacturing processes on self-sufficient portable platforms, with the capability to be transported to where manufacturing is required, plugged in and operated with minimal interference. Not only does this unlock the potential to streamline supply chains from an operational cost perspective, but also can unlock potential tax benefits from the manufacture and transfer of products within different countries.

On top of this, having a location-flexible manufacturing process provides the security of being able to withdraw manufacturing capabilities quickly from facilities in instances of location-specific challenges such as natural disasters or political turmoil, to secure the flow of product and business continuity.

2. Rapid production scale-up / scale down

Fluctuating demand for products can present significant challenges, which has been amplified in the past 12 months. Whilst existing systems, with their fixed batch sizes, elongated manufacturing lead times and heavily restricted manufacturing runs flounder, a continuous manufacturing unit offers the flexibility to produce the quantity of material as required, with minimal lead time. If a unit is at maximum capacity, a second identical unit could potentially be flown in and run alongside, following the ‘scale-out’ methodology of increasing throughput.

This clearly allows a pharmaceutical company to capture lost revenue from potential stock-outs of critical products, but also allows this to happen at the same time as significantly reducing the level of safety-stock required. This delivers significant financial benefits on both the balance sheet, and in the running costs of the supply chain network.

3. Automation and digitization

The ‘steady-state’ of continuous unit operations makes some of the digital-twin modelling of a manufacturing process much simpler. This has the benefit of unlocking the use of Performance Analytics Technology (PAT) testing to indicate the quality of the product leaving the process, which has already been demonstrated to allow real-time quality release, in the place of the currently minimum two week delay whilst product quality is assured.

In addition to this, the strides forward in modelling and digital twin development unlock many of the Industry 4.0 capabilities that are becoming commonplace in other product-types. This includes predictive-demand-based manufacturing automation, global supply chain modelling and the ability to track a product quality incident down to the second from the start of manufacturing through to the hands of the patient.

Still looking for a reason to change?

You may ask why, if this is such a game changer, more focus hasn’t been put on innovating manufacturing to allow the supply chain to be further optimized. Up until now, the blockbuster model of drug development has kept the relatively minute cost of product distribution in the shadows because it is a small fraction of the expenditure around a product. However, as this old paradigm starts to shift, and innovative and niche product areas such as personalized medicine come to the forefront, the supply chain becomes a critical success factor to meet the needs of a patient. This results in a return on investment rapidly becoming more beneficial to the business, with critical value generators such as:

  • significant reduction in safety stock requirements;
  • optimization of supply chain transport costs;
  • value creation through tax benefits;
  • security of product flow;
  • reduction in facility operational costs;
  • fulfilment of significant demand spikes;
  • and many more…

These, added to the increasing value of agility in the supply chain, will further strengthen the business case to make continuous manufacturing a commonplace option for product manufacture in the next 5-10 years.

Find out more about continuous manufacturing in pharma.

 

by Scott Mahoney Principal at PwC Management Consulting, PwC United States

+1 617-306-8718