Not surprisingly, industries operating in a free market tend to emulate and implement successful practices from divergent
industries. This tendency is particularly true for technology-based industries such as biopharmaceuticals and software development—two
industries that are customer-focused and rapidly changing. Although the term "platform" dates back hundreds of years, the
concept of developing a platform or framework off of which subsequent products can be launched originated in software development.
Current industry leaders in software development have implemented this concept with great success. Over the past decade or
so, biopharmaceutical companies have applied platform processes to various aspects of their operations. The concept has gained
considerable traction within the field of bioprocess development as an increasing number of groups have implemented it and
begun touting its benefits in quick succession. However, as with any idea, there are benefits as well as disadvantages that
need to be assessed prior to and concurrent with implementation.
TOUTING THE PLATFORM
The central argument in favor of a platform process, particularly in the context of bioprocess development, is that it expedites
project timelines. By leveraging similarities between new molecules, a platform process enables resources to be deployed efficiently,
reducing costs while also shrinking timelines. Everything from cell-culture expansion steps to filter sizing can be grouped
together to form a comprehensive, thaw-to-formulation platform process. Particularly in the context of preclinical and early-phase
clinical production needs, platform processes allow for rapid development of molecules. Even for late-phase clinical production
needs, a platform process provides a starting point for subsequent development, readying a process for regulatory approval
and eventual commercialization.
More specifically, platform processes also allow bioprocess development groups to focus on those aspects of the process that
require greater evaluation or development such as viral clearance and bioreactor harvest criteria. For instance, viral clearance
must be demonstrated under the conditions employed during purification steps to ensure the safety of the end product. Orthogonal
steps capable of removing viral contaminants by alternate modes of action must be employed, with the performance of each step
quantified. Because each molecule is different, with different physiochemical properties such as its isoelectric point (pI),
and purified under slightly different conditions (i.e., buffers, pH, and conductivity), viral clearance must be demonstrated
routinely. Similarly, specific cell-culture conditions can degrade the desired product based on culture duration (i.e., temperature
and pH), cell viability, and the onset of apoptosis.
Determining how these and other factors affect product quality is vital to successful transfer and implementation of a GMP
process. It is crucial to understand these operations because of their potential to affect release of the final product. Therefore,
both operations need to be explored in detail. With a platform process in-hand, many noncritical operations can be ignored
and run based on the platform, focusing instead on critical operations such as the two described above. This ability to prioritize
effectively while maintaining a high level of process understanding is another benefit of platform technology.
Another realized benefit of employing platform processes is that it simplifies the complexity of the interactions taking place
between groups inside and more importantly outside of the process development group. Groups such as quality assurance, quality
control, logistics/supply chain, and manufacturing can all benefit from process development's use of platform processes. For
instance, vendors for everything from growth media to chromatography resins can be assessed once (audited and certified by
quality assurance) and relied upon routinely because multiple programs will use the same raw materials and consumables. Similarly,
specifications defined by quality control and material numbers defined by logistics can be defined once and be used for multiple
programs. Implementation of a platform process also espouses confidence in manufacturing groups because preparing and executing
batch records are simplified. In other words, all of these groups external to process development benefit from standardized,
well-defined workflows that have been previously tested and shown to be effective; a hallmark of a true platform process.
In fact, the better the platform, the more these desirable characteristics can be achieved.