IDBS BlogRegulated drug development

IDBS Blog | 19th April 2021

Drug Safety and the Public Consciousness

Regulated drug development

The public consciousness has been flooded with awareness of the previously niche concerns of quality control in drug manufacturing. With this increased awareness, and the broader scrutiny that results, the biopharmaceutical industry can educate the public on the steps it takes to ensure drug safety. Indeed, many consumers may not have considered that drug safety is a consideration that extends far beyond a medicine’s discovery and development stages. Nor may many consumers have considered the role of contract manufacturing in the drug commercialization process, instead assuming that drug discovery, development, qualification, and manufacture take place “under one roof.”

Several recent examples have highlighted the impact of deceptively simple errors on drug safety. In one case the use of faulty lab materials set back product development by several months and in another, a mix up of ingredients between products resulted in a lost batch – amounting to millions of doses – and prompted a regulatory review. Both of these reports highlight areas in which perils to drug safety can jeopardize the delivery of urgently needed medicines to market. These include:

  • Inadequate disinfection
  • Prevention of contamination
  • Insufficient qualification of raw materials
  • Training deficiencies

Interestingly, a related story suggested the solution requires “close monitoring” on the part of regulators. While regulatory agencies obviously play a key role in assuring product quality, monitoring by a regulator tends to detect the trailing indicators of safety issues, and potentially only after significant errors have already squandered time and resource, not to mention the continuing impact on unmet medical needs.

Is there a more prescient remedy? In a BioPharma Lifecycle Management (BPLM) context, quality can be engineered into processes, providing the process design and understanding required to minimize manufacturing deviations and contemporaneously monitor product quality. While the maxim “better late than never” could apply, there is no doubt that sooner is better. With BPLM as an engine for ICH Q10 and other industry guidelines, drug safety and quality can be managed and controlled proactively throughout the lifecycle.

The experience of IDBS experts bears out this assertion. Solution Owner for IDBS Polar Bioprocess, Unjulie Bhanot, commented, “making sure pharma companies have the right integrations across all systems, software and instruments, and that the right reporting needs are plugged in from the very beginning to access and action the data is key.”

“There are manual, disconnected, paper-based processes still being used in labs that limit the ability to get to market quickly and make effective decisions. Making these processes digital opens up new possibilities for real-time collaboration. By bringing more minds to a problem and more insight to a team, results are better and companies can gain a competitive edge in the pharma marketplace,” added Polar HTPD leader Matthew Clifford.

There is a public education element to this too. The biopharmaceutical industry has rarely been under greater scrutiny, and mistrust of the industry at this moment can have major public health consequences. We consider IDBS to play a pivotal role in this assurance of quality and confidence in the research, development, and manufacture of vital drug product, and look forward to leading this conversation among biopharma, contract services, software vendors, regulators, and industry advocates.

#biopharmaceuticallifecyclemanagement #IDBSPolar

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