The company said it commissioned independent research among 31 key players in the UK and Irish biopharma industry to discover key areas for business improvement. The study was conducted between late 2019 and early 2022, covering the period affected by the global pandemic.
The findings reveal that with much pharma manufacturing still employing heavy use of paper-based records, the adoption of electronic batch records can help streamline process operations, improve regulatory compliance, and reduce operational costs.
The report expects digital transformation in biopharmaceuticals to pick up speed across the rest of the decade, with an increasing gulf likely to open up between leaders and laggards.
Andrew Matthews, head of pharmaceuticals, Siemens, said the research underlines areas for consideration as identified from the wider industry and is designed to spark further discussion. He also noted that a percentage of pharma players have not heard of Industry 4.0 or Pharma 4.0, with some delegates at a recent event not up to speed on aspects on digitalization components such as digital twins.
The paper found that standardization of process control, data protocols and interchangeable plug-and-play components is a clear priority, both within pharma firms and between different participants – originators, R&D, subcontracted manufacturing, etc.
And a key trend anticipated by respondents, according to the report, is that contract development and manufacturing organizations (CDMOs) will become more digitally integrated with their originator clients. Consequently, it is believed that processes such as contract supply terms negotiations will be easier to set and monitor. “Similarly, administering production time slots, quantities and project management standards becomes far more transparent, easy and rapid-response. Much may be automated.”
The authors also commented that, within the UK, the biotech and pharma services outsourcing market is expected to reach £4.1bn (US£4.7bn) by 2028, growing at a CAGR of 6.9%, citing data from a December 2021 market report.
“This marks a critical trend where product originators are increasingly outsourcing their discovery work to Contract Research Organisations (CROs) and a proportion of their manufacturing to Contract Manufacturing Organisations (CMOs).”
Drug discovery process
Some interviewees highlighted the importance of compressing the drug discovery process, in particular, using Industry 4.0 technology to accelerate the speed of new molecule development, such as through computational chemistry and data-driven discovery.
A number of examples of pioneering work in this field exist where data analytics and Artificial Intelligence (AI) are being used to accelerate the discovery process – rapidly generating testable hypotheses from complex, omic, and multi-omic biological data sets – in areas such as novel cancer drug targets and bioactive peptides, according to the findings.
AI can also help expand the drug discovery universe by making predictions in more novel areas of biology and chemistry, identifying relevant information faster and making links between biomedical entities often with relatively little information, commented the authors.
The mass of data produced in digitalized drug discovery also means firms can develop predictive analytics that spot and avoid failures early, saving time, costs and avoiding delays in the discovery process, they said.
A commentator confirmed that about 50% of late-stage clinical trials fail due to ineffective drug targets, resulting in only 15% of drugs advancing from Phase 2 to approval. As well as data-driven discovery, interviewees noted the importance of introducing robotics in the development laboratory, which can automate ‘menial and repetitive’ tasks such as creating many mammalian cell culture batches simultaneously and capture the emerging data.
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Reduced compliance costs
Visibility of digital data flows in all aspects of biopharma – from concept to clinic – is also contributing to regulatory supervision, reducing the burden on biopharma companies, and at the same time increasing hard-pressed regulators’ and notified bodies’ ability to scrutinise the industry, reads the publication.
"It’s only a matter of time before we see remote inspections by the regulators becoming the norm,” said one respondent.
Automated compliance and risk reporting – at least at the manufacturing level, if not (ultimately) across the whole supply chain can reduce compliance costs and build market and regulator confidence, said the authors.
Respondents are focusing on digitalizing as much as possible in the process line. For instance, small-scale bioreactors with automatic data collection, analysis, and visualization, allow much closer monitoring and control of process and performance parameters, found the paper.
This can in turn enable faster, more reliable, process line development and set-up; and the overall result is faster time to market. According to a respondent: “Digitalization is helping MES systems deliver better value, consolidating and defragmenting the management and process control visibility.”