4 methods to improve bioreactor scale-up efficiency in drug development
Bringing drugs to market as quickly and cheaply as possible is imperative to treating the many diseases afflicting humankind. However, many of the diseases still untreated today are resistant to standard small-molecule therapies, so pharmaceutical companies are turning to biologics and biosimilars to combat these difficult to treat diseases.
Unfortunately, developing biologics is slower and more expensive than traditional drug development – making it more important to find ways to efficiently scale up bioreactors at each step, from R&D through clinical trials, to large-scale production.
Here are four strategies to improve speed and reduce cost of scaling-up biologics development.
1. Transition to SUBs
Single-use bioreactors (SUBs) have much lower startup and operating costs than traditional stainless steel or glass reactors, and they offer an unprecedented degree of flexibility for batch sizes of less than 2,000 liters. Since SUBs are single use, they eliminate the need for clean-in-place procedures and reduce risk of contamination. This means more reactor uptime and better product purity. Overall, SUBs are ideal for the clinical trial stage of drug development leading to production scale-up.
2. Expect redundancy and versatility
Equipment redundancies in research and manufacturing reduce the footprint of a setup and the cost of development. For pilot builds, this means backup functionality in case there are issues with a process or equipment.
An excellent example is a mass flow controller with multi-gas selection. Researchers can use a single device to switch between flowing air, oxygen, nitrogen, and carbon dioxide without the need for recalibration. For larger-scale setups flowing all four gases simultaneously, operators need only one backup controller, which can be “hot-swapped” to control any gas.
Equipment and sensors with high turndown ratios, such as the plastic vessels used in SUBs, provide an additional degree of redundancy because of their wide functional range. This versatile equipment helps maintain a functional work environment that limits downtime, reduces footprint and saves money, all while increasing the flexibility of the setup.
3. Work closely with a CDMO
Contract development and manufacturing organizations (CDMOs) provide valuable support to your internal team. These organizations can provide equipment that may be more modern, automated, or otherwise up-to-date than your in-house equipment. They also possess a wide breadth of experience in process development and manufacturing, enabling your team to fully focus on its area of expertise – whether that is early-stage research, running clinical trials, or next-generation drug development.
It is important to note that there are various types of CDMOs, so be sure to choose one that best fits the scope of your project.
Modular systems are gaining popularity as they can greatly increase the ability to rapidly move a drug product through development phases. Thermo Fisher Scientific’s Hyperforma GXCore is designed to scale with benchtop research through pilot phases. Cytiva has designed a pre-fabricated GMP facility, KUBio, optimized specifically for use with FlexFactory single-use equipment.
Modular prefabs are particularly advantageous during bioreactor scale-up, when discrete, standardized components offer speed and agility for system design.