Business Case Insights for Continuous Manufacturing

CMAC and PwC are delighted to share ‘The Business Case Insights for Continuous Manufacturing’. This joint document, with input from industrial partners, seeks to review key considerations for building a successful business case for the industrial adoption of innovative Continuous Manufacturing (CM) technologies.

The report is written from the perspective of the CMAC manufacturing research programme stakeholders. Hence, it targets factors directly relevant to continuous small molecule pharmaceutical manufacture and although addresses the many drivers and impacts across the entire value chain, brings a strong emphasis on factors relevant to continuous drug substance manufacture.

With the associated growth in new technologies and services comes the opportunity for different business models that exploit CM to deliver additional value and tackle major challenges facing the sector: how are we to manage spiralling prescription medicine costs in the NHS and other global healthcare systems; can the pharmaceutical supply chain deliver greater personalisation of medicines quickly and cost effectively; can the security of global medicines supply be assured to maintain access to essential medicines or respond to medical emergencies; how can the impact of medicines manufacture on the environment be minimised and made more sustainable? Those that can best harness the potential of innovative technologies such as CM will be best placed to meet these challenges.

Nine critical considerations have been highlighted for business case development. Through each of these lenses, a holistic case for continuous manufacturing can be progressed to help drive the uptake of this currently novel technology.

Please view full document here

This document was undertaken with engagement from CMAC Tier 1 partners AstraZeneca, Eli Lilly, Pfizer and Takeda as well as leveraging CMAC’s own extensive academic portfolio on end-to-end (E2E) processing. CMAC would like to thank all those who have contributed information and viewpoints on key technical aspects in combination with PwC’s wider business case perspective, to help inform and engage senior stakeholders and drive continuous manufacturing forward.

CMAC Strategy

Transforming Medicines Development & Manufacture

The CMAC Strategy document provides a common vision for the CMAC direction, with particular focus on the implementation and translation of our manufacturing research programme.

The 2023 Vision and Implementation Plan is set out across the 4-pillars:

  • Research Excellence
  • Outstanding Skills Development
  • World Class Facilities
  • Exemplary Translation to Industry

The pharmaceutical industry is dealing with significant change as demands from patients, payers and healthcare systems drive increased complexity in the design, development, manufacturing and supply of future medicines. CMAC, with 8 Tier 1 Pharma companies and a thriving Tier 2 community, has been built on pre competitive, industry led collaboration and is delivering an ambitious and impactful research programme.

Ensuring CMAC delivers research excellence and outstanding skills development, whilst establishing world class facilities and promoting exemplary translation to industry, is critical to sustainable success and a focus for the industry partners. 

The environment is changing with the formation of the UK Research and Innovation body (UKRI), the Medicines Manufacturing Industry Partnership (MMIP) and targeted funding through the Industrial Strategy Challenge Fund, and as such, CMAC is well positioned in providing a clear and influential voice in this new international ecosystem.

The full document can be viewed here