Some Common Scale-Up Challenges:
- Four principal non-chemistry scale-up challenges that CDMOs and CMOs usually face when offering formulation scale up contract services include scaling to meet requirements, ensuring regulatory compliance of pharmaceutical products, securing adequate funding for drug product development and manufacturing, and protecting intellectual property.
- A substantial amount of expertise is required to seamlessly take products from preclinical to clinical and then to commercial scale. As such, it is important to ensure that the necessary steps and evaluations are carried out in order to manage complexities and reduce timelines.
- During plot plant scale-up projects various issues may arise including challenges associated with non-linear scale up, reaction kinetics, chemical equilibrium, material properties, fluid dynamics , thermodynamics, equipment selection, and agitation issues. Several in-depth engineering studies are required to overcome these scale-up challenges.
- Even for specialized contract development and manufacturing organizations (CDMOs), the journey from preclinical to clinical operations to pharmaceutical manufacturing for commercial drug products or drug product commercialization possesses its own slew of challenges such as capacity issues, general growth complications, internal culture, management maintenance, and standardizing a complicated operation for the mass market.
- One of the biggest concerns pharmaceutical manufacturers have when transitioning from small-scale to large-scale operations during the scale-up process is that they face a higher risk of pharmaceutical product contamination as they get to grips with new processes.
Some Common Challenges Associated with Pharmaceutical Technology Transfer:
- There are many barriers to successful technology transfer. All along the transfer path, from the supply side of technology to demand side, impediments occur at every node and, due to restrictions on movement of information and materials, for every linkage in the technology transfer chain.
- Technology transfer barriers comprise of issues relating to technical, organisational-economic, and system barriers. The three principal problems to be considered are asymmetric information, market power, and externalities. In addition, uncertainty regarding the qualities of the innovation as well as future prices of inputs complicate the technology transfer process.
- Technology transfer is a complex process involving several disciplines and with many associated risks that need to be managed. These risks can be more evident within any organization when transferring full manufacturing from one culture to another. In such cases, managing technology transfer and supporting the new drug product manufacturing site can become more complicated due to cultural and organizational differences between the involved sites.