Note: BioTechLogic is proud to be featured in the December 2016 issue of Pharmaceutical Manufacturing magazine.
The global biopharmaceutical market is expected to grow at a compound annual growth rate of 9.4 percent from 2014 to 2020, reaching $278 billion in revenue by the end of this six-year period. Growth is being driven by numerous factors, such as aging populations in most of the Western world and an increased prevalence of chronic disease. However, likely the most important contributor to growth is biopharmaceutical drugs’ superior effectiveness in treating many disease states, including treating conditions for which there were previously few effective drug treatment options available.
Given the growth of the biopharmaceutical segment, the industry needs to become increasingly better at managing biopharmaceutical projects in order for more treatment options to become available to patient populations. The objective of any project management pursuit is to complete the project on time, within budget, and within required quality or performance parameters. Given the complexity and intense regulatory demands of the pharmaceutical industry, project management is more difficult than many other segments. As if pharmaceutical projects weren’t demanding enough, biopharmaceutical project management is exceptionally challenging, requiring unique experience and expertise.
Biopharma project management challenges
Chemically synthesized drugs are typically better characterized by fairly established analytical technologies and techniques spanning the complete product lifecycle. Also, analytical techniques and manufacturing processes are typically more consistently repeatable, including at large commercial scale.
Biologics, on the other hand, have very complex production processes and are affected by a wide range of factors, including the cell system in which they are produced and inputs such as fermentation media and operating conditions. It is not easy to scale up biologics from laboratories with the quantities used for early analysis and pre-clinical testing to larger-scale batches, while maintaining product quality and batch-to-batch equivalence. Additionally, typically complex bioassays are required for batch release and stability assessment — testing that is usually more complex than the testing required for small molecule drugs.
Finally, because there is still a lot we don’t fully understand about the nature, characteristics and behaviors of living cells, outcomes are less predictable.
