| Increased competition, shareholder influence and challenging targets are putting biopharmaceutical manufacturers under pressure. Eugène van Dijk at WCI Consulting Limited looks at how biopharmaceutical companies are improving quality and the challenges that they face scaling up quality control
It is now widely understood that designing manufacturability into a product at an early stage is key. Scaleability and productivity have become key drivers for selecting both cell lines and technology. However, when it comes to quality control, these principles are not widely applied. During the development and technology transfer stage, analytical methods are put in place to please the regulators, as well as to guard a process that is not yet fully under control. Subsequently, these methods are cemented into the biological license application, without much thought about manufacturing efficiencies, lead-times and sample cost.
During the scale-up and further lifecycle of the product, focus is on training the analysts in the necessary developed methodologies. Although increased volumes put significantly different requirements on the analytics, there is little-to-no focus on changing the analytical methods. Even if an initiative is launched to look at improvements in this area, it is most likely put on ice as soon as it crosses into the ‘dead zone’; that is, when changes to the submission are required. This makes any change to the existing analytical tests extremely difficult.
Taking a further step towards a more risk-based approach, identifying when to perform which tests, even when promoted by the regulators, is simply unheard of. Yet, when manufacturing volumes start to go up, both manufacturing and quality control start to feel the pain this causes.
QUALITY CONTROL – NOT INDEPENDENT BUT AN INTEGRAL PART OF THE SUPPLY CHAIN
Although from a regulatory point of view, quality control needs to be an independent player and part of quality operations, business wise they are very much an integral part of the supply chain. Bad performance within quality control has a direct impact on manufacturing and overall supply chain performance. Manufacturing is faced with an inflexible and uncompromising process, having numerous in-process tests, add to the overall manufacturing complexity and lead-time. |
