All life sciences manufacturers face a host of pressures, stringent regulations, and potential pitfalls. In the clinical manufacturing sector, these challenges are intensified to an even greater level of complexity. Manufacturing materials and supplies for clinical trials involves smaller batches and greater variables, which heightens the complexity of production efforts and the precision that is required to carry out processes.
There are three significant challenges clinical manufacturing entities face that aren’t typically constraints for most commercial life sciences manufacturers:
These challenges are only compounded when paper-based processes are used. Manufacturers of clinical products who can successfully manage these challenges on an ongoing basis share two commonalities:
The intersection of quality and manufacturing through digitization is so pivotal to success in clinical manufacturing that it was identified in MasterControl’s latest industry brief as one of four critical capabilities that manufacturers must master to stay competitive in the field.
Rapid, continual change is the hallmark of clinical manufacturing environments. The persistence of change means that clinical manufacturers must be more agile and operationally adaptable than most companies that manufacture regulated products, as noted above. But a greater need for flexibility places heavier demands on an organization’s quality function. It requires quality teams to be nimble when situations demand it without sacrificing their ability to enforce the appropriate controls when they are required.
In clinical manufacturing, a quality department’s enforcement of good manufacturing practices (GMPs), which were devised with large-scale commercial operations in mind, must be selectively tailored to meet individual circumstances. As a result, clinical manufacturers need systems that allow them to make many changes quickly — and often systemwide — with the least amount of effort and friction.
Disconnects between manufacturing and quality are nothing new in manufacturing environments. Even so, the lack of data connectivity poses major obstacles across life sciences industries and is hitting the velocity-focused world of clinical manufacturing particularly hard. Industry analysis firm LNS Research noted the problem in a survey of manufacturing operations managers of life sciences companies.
More than 20% of survey respondents identified the following issues as the two main obstacles to meeting manufacturing objectives:
The pervasiveness of these issues makes it clear that clinical manufacturers who delay digitization will continue to struggle. Organizations that choose not to integrate quality and manufacturing processes do so at their own peril.
As digitization enables more clinical efforts to be spread across different locations, cloud technologies are proving to be invaluable tools. Cloud-based platforms have become indispensable frameworks that enable companies to overcome common clinical pitfalls and unite their efforts within a shared architecture. Advancing the use of web-based technologies in clinical activities is essential to the industry’s progress, according to Stephen Mayo, founder and CEO of the clinical research organization (CRO) Emissary International.
“The completely paperless clinical trial could soon become a reality,” Mayo said. “The lesson: Use the web to help make the clinical trial process faster, cheaper, and more efficient.”(2)
Implementing an integrated cloud platform to digitally connect production with quality enables clinical manufacturers to overcome conventional challenges and can bring substantial benefits such as:
Stephanie Kuhn, senior director of quality assurance at leading contract development manufacturing organization (CDMO) Ology Bioservices, has seen firsthand the advantages of uniting quality and manufacturing processes and data. At the 2020 Virtual Masters Summit, she shared her top 10 list of benefits companies can attain by harmonizing manufacturing and quality efforts within a single cloud-based platform as her organization has. According to Kuhn, platform integration enables a company to:
Early integration of quality within a shared platform is just one piece of the clinical manufacturing puzzle. For more insights that can help your company accelerate clinical manufacturing processes, check out the “Mastering 4 Critical Capabilities in Clinical Manufacturing” industry brief.
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