Quality takes centre stage as biopharma companies shift their focus to biotech
SummaryAs new drug development gravitates away from chemical synthesis towards new and costly biotech therapies and vaccines, the Quality function is becoming increasingly central to optimising manufacturing processes. Dr. Eduard Cayón of Rephine/ TDV outlines how Quality can add value for emerging and established biopharma companies.
- Author Company: Rephine/ TDV
- Author Name: Dr. Eduard Cayón
- Author Website: https://www.rephine.com/
The increasing change of focus in pharma, away from small chemical molecules towards biotech products and personalised therapies, is driving a change in the requirements of manufacturing sites, equipment and processes needed for this new environment. For young biotechs, scaling up production brings green-field challenges, while for more established pharma businesses a shift may be required to ensure that facilities are optimised for new ways of working.
Across all of this is the criticality of compliance with Good Manufacturing and Good Distribution Practice (GMP/GDP), and of a fit-for-purpose Quality system. Engineering or redesigning facilities without due consideration of what’s needed, of what may be superfluous, or of how systems and processes will be validated over time, could lead to costly remedial action and delays in getting important and premium new products to market.
Beyond adapting existing sites or engineering new facilities geared to modern drug production, biopharma companies also need to be more cost-conscious than ever because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.
Quality facilitating manufacturing efficiency
Gearing up for efficient, optimised and compliant production at scale in a cost-sensitive, biopharma-first world, means creating an environment in which Quality must serve as a real-time facilitator of first-class manufacturing.
Historically, in some cases, pharma Quality systems were put in place largely to help companies pass inspections, rather than to foster innovation by adding inherent value as part of the production process. When that happened, systems existed on the periphery of manufacturing, generating after-the-fact documentation rather than being an integral part and enabler of proceedings.
Today, manufacturers have an opportunity to be more discerning about the measures they put in place to ensure and track Quality, and to integrate and embed Quality Management much more within real-time processes, where it can more tangibly add value as a discipline.
This presents a chance to be smarter about the level and scope of detail captured, for instance, and to gear at least some of the tracking, analysis and issue-flagging to enabling internal efficiency gains, by digitalising workflow management and applying intelligent process automation.
One of the drivers of the shift in Quality in biopharma manufacturing is the evolving regulatory climate which – in an attempt to be more supportive of innovation - is shifting towards risk management and health authority approval based on the given risk profile. This is in contrast to the approach of 20+ years ago, which favoured indiscriminate documentation, vetting and validation of every small detail against a positive list of requirements, for the sake of being thorough.
Optimising quality processes
The ‘relaxing’ of inflexible Quality-related regulatory requirements presents an opportunity for manufacturers to use systems and measures to their own operational advantage (without compromise to Safety, of course). When they apply digital solutions, this should be not just to replicate old, manual processes, but to enable process redesign and process optimisation.
New biotechs, emerging from the labs into commercial-scale production, have a greater advantage with all of this, not being influenced or unduly held back by legacy Quality processes. As they establish full production facilities, they have a chance to incorporate Quality ‘by design’ building, harnessing emerging best practice and applying risk management to determine what scaled-up production should look like in the 2020s, and what process weaknesses to avoid to achieve frictionless validation.
Moving straight to highly integrated and digitalised processes, which allow for real-time data to flow to where it’s needed and trigger next actions, can significantly heighten the chance of success – affording clear visibility across production, and creating the potential for automatic alerts, reminders and prompts based on given parameters to keep everything fluid and dynamic.
The more that functions, systems and processes can be interlinked, the greater the scope for improvement, too. Connecting historical incident data to risk management for process optimisation, and ERP systems for materials management, offers Production and Quality teams optimal scope to stay ahead, while also reducing the number of review cycles (on the basis that if a computerised system has been validated, it can be trusted).
Cutting through red tape
As manufacturers seek to capitalise on biopharma product innovation, amidst high price and cost sensitivity in the market, they can’t afford to be held back by excessive red tape, unwieldy processes, or siloed teamwork. Fortunately, it doesn’t have to be like that - as long as good practice starts with the right advice.
Companies already have a plethora of tools available to them – from management systems and control software, to process monitoring data, to sampling and certification of analysis systems – enabling them to capture all the data they need to satisfy regulators and auditors and to optimise performance through effective Quality processes.