The company said it commissioned independent research from 31 key players in the UK and Irish biopharmaceutical industry to uncover key areas for business improvement. The study was conducted between late 2019 and early 2022, covering the period affected by the global pandemic.
Findings reveal that with much of the pharmaceutical industry still using paper-based records, adopting electronic batch records can help streamline process operations, improve regulatory compliance and reduce operational costs. .
The report expects digital transformation in biopharmaceuticals to accelerate over the remainder of the decade, with a growing gap likely to open between leaders and laggards.
Andrew Matthews, head of pharmaceuticals at Siemens, said the research highlights areas for consideration as identified by the wider industry and is designed to spark further discussion. He also noted that a percentage of pharmaceutical players had not heard of Industry 4.0 or Pharma 4.0, with some delegates at a recent event being unaware of the component aspects of digitalization such as digital twins.
The article revealed that the standardization of process control, data protocols and interchangeable plug-and-play components is a clear priority, both within pharmaceutical companies and between the various participants – originators, R&D, manufacturing under -processed, 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 customers. Therefore, it is believed that processes such as negotiating contract supply terms will be easier to set up and monitor. “Similarly, the management of production time slots, quantities and project management standards becomes much more transparent, easier and faster. Much of it can be automated.
The authors also noted that the UK biotech and pharma services outsourcing market is expected to reach £4.1 billion (£4.7 billion) by 2028, with growth at a CAGR of 6.9%, citing data from a December 2021 Market Report.
“This marks a critical trend where product creators are increasingly outsourcing their discovery work to contract research organizations (CROs) and some of their manufacturing to contract manufacturing organizations (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 development of new molecules, for example through computational chemistry and data-driven discovery .
There are a number of examples of pioneering work in this area where data analytics and artificial intelligence (AI) are used to accelerate the discovery process – rapidly generating testable hypotheses from biological datasets. complexes, omics and multi-omics – in areas such as novel cancer drug targets and bioactive peptides, depending on the results.
AI can also help expand the universe of drug discovery by making predictions in newer areas of biology and chemistry, identifying relevant information more quickly, and making connections between biomedical entities often with relatively little information, the authors commented.
The mass of data produced in digitized drug discovery also means companies can develop predictive analytics that spot and avoid failures early, saving time, costs and avoiding delays in the discovery process, they said.
One commentator confirmed that around 50% of late-stage clinical trials fail due to ineffective drug targets, resulting in only 15% of drugs advancing from phase 2 to approval. In addition to data-driven discovery, interviewees highlighted the importance of introducing robotics into the development lab, which can automate “menial and repetitive” tasks such as creating multiple batches of cultures at once. mammalian cells and emerging data capture.
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Reduced compliance costs
The visibility of digital data streams in all aspects of biopharma – from concept to clinical – also aids regulatory oversight, reducing the burden on biopharma companies and, at the same time, increasing the capacity of regulators and agencies. notified under pressure to control the industry. , reads the publication.
“It’s only a matter of time before we see remote inspections by regulators becoming the norm,”said one respondent.
Automated compliance and risk reporting – at least at the manufacturing level, if not (ultimately) across the entire supply chain can reduce compliance costs and build market and regulator confidence , the authors said.
Respondents focus on digitization as much as possible in the process chain. For example, small-scale bioreactors with automatic data collection, analysis and visualization allow much tighter monitoring and control of process and performance parameters, according to the article.
This in turn can enable faster and more reliable process line development and configuration; and the overall result is faster time to market. According to one respondent:Digitization helps MES systems deliver better value, by consolidating and defragmenting visibility into process management and control. »