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The biomanufacturing facility of the future

Maintaining a competitive advantage through ecosystems

The Digital Biomanufacturing Working Group, a group of small to large biomanufacturing companies, service providers and academia led by Deloitte and bio.be/essenscia, confirms biopharma is still behind on digital maturity, yet new digital technologies are becoming more widespread to address key challenges impacting biomanufacturing facilities.

Key takeaways

  • The majority of biopharma companies have drawn out their digital manufacturing strategy with imple-mentation efforts focused on automation of low-value added tasks and digitisation of shop floor activi-ties.
  • Skills, talent, and data governance are lagging areas preventing companies to truly grasp the full bene-fits of the available data and overall digitalisation efforts, with regulatory scrutiny and uncertainty of re-turns impeding further adoption of transformational use cases.
  • An ecosystem where industry, academia, and government are collaborating is paramount to gain and retain a competitive advantage in the global biotech scene by sharing knowledge and expertise on selecting appropriate investments, implementing best practices, funding opportunities, and talent requirements.

Why does this matter?

Although the biopharma industry has typically lagged in terms of digital maturity, the rapid advance and proven value of new digital technologies is offering biopharma companies opportunities to address key industry challenges:

Manufacturing process complexity – The rise of biologics and cell and gene therapies, combined with the  exploration of continuous manufacturing, have led to more complex manufacturing processes which are exposing the limitations of traditional quality and process control methods.

New care settings and services – Uncertainty around impact and requirements of patient-centred, value-based services challenge the current manufacturing and distribution set-up.

Pricing and cost pressures – Pricing pressure from reductions in reimbursements and buyer consolidation has led to significant pressure to transform the cost structure to counter margin erosion and improve capital and asset efficiencies.

Increased regulatory scrutiny – Increased regulatory complexity and requirements put pressure on the manufacturing processes and limit agility as well as the ability to scale.

Initiating an ecosystem around the biomanufacturing facility of the future

A joint collaboration between bio.be/essenscia, the federation for Belgian
companies active in life sciences and biotechnology, and Deloitte led to the
initiation of a digital working group in September 2020 with the objective to understand the digital landscape, to benchmark and learn from lighthouse experiences, share best practices, and shape the future biotech landscape in Belgium. 

With the support of multiple biopharma companies, and insights from external
partners, an interactive discussion platform was created with the aim to look
deeper into several topics linked to establishing the biomanufacturing facility
of the future, ranging from more general, strategic topics down to specific use
cases and technologies:

  • A holistic digital maturity assessment was developed that touches upon the different elements of the future biomanufacturing facility with topics specific to factory functions, and others more focused on the use of technologies, and enabling capabilities like skills, digital strategy, cybersecurity and data governance.
  • Ten companies participated in the maturity assessment providing a picture on the overall state and maturity of digitalisation within Belgian biopharma facilities, combined with personalised feedback for each participant where their leading areas have been highlighted along with potential, future opportunities

In addition, deep dive sessions were organised based on the outcome of the digital maturity assessment and the interests of the participants, covering process analytical technology (PAT), automation, digital skill requirements, simulation and advanced analytics with concrete examples provided by solution and equipment providers like Univercells Technologies and RheaVita.

Key highlights of the digital maturity assessment

  • With high awareness of the case for change, the majority of companies haves focused their efforts on digitising manufacturing processes to get rid of paper on the shop floor, whilst automating low-value adding tasks.
  • The majority of the participants are struggling to derive meaningful and sustainable insights from captured data due to lacking data governance, and limited analytics knowledge and capabilities.
  • More than 50% of the participants are not aware of government support programmes to accelerate their digital initiatives.
  • Only 10% of the participants consider they have sufficient digital skills across site functions, with the majority still struggling to identify the required digital skills and related training programmes.

A continuous journey to maintain and scale the ecosystem

With many biopharma companies still taking the first steps to generating value from applying new digital technologies in their manufacturing operations, continued experience sharing amongst industry players will be key to accelerate the transformation and allow biopharma sites to retain their competitive advantages. In order to support experience sharing, the industry working group and collaboration between bio.be/essenscia and Deloitte will continue through:

  • Additional deep dives into topics with respect to the biomanufacturing facility of the future
  • Webinar to share the outcome of the overall working group findings and maturity assessment 
  • Continuous onboarding of new biopharma companies interested in being part of this community and with a desire to benchmark their digital maturity with industry peers

About the Digital Biomanufacturing Working Group

The working group has brought together a combination of small to large biomanufacturing companies complemented with service providers and academia participating and contributing to the overall working group. For more information on participating companies and the working group visit www.essenscia.be/digitale-revolutie-op-komst-in-belgische-biotech-kans-of-bedreiging/

About bio.be/essenscia

bio.be/essenscia is the federation for Belgian companies active in life sciences and biotechnology representing and looking after its members’ interests in the legislative and normative field, both in Belgium (federal and regional) and at European policy level. Its mission includes the realization of a stable legal framework that fosters innovation in biotechnology. bio.be/essenscia also promotes the image of the biotech sector by putting the development of innovative products and applications that greatly improve the quality of life internationally in the spotlight. Under the umbrella of essenscia, the Belgian federation of chemistry and life sciences, bio.be/essenscia has access to specialized advice and expertise within an extensive network of partners both in Belgium as abroad. bio.be/essenscia is also a member of EuropaBio.

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