Resin lifetime studies are a regulatory requirement for new drug application (NDA) filing. But are running these lengthy and repetitive studies the best use of your process development time? Here are the top 5 reasons for outsourcing resin reuse studies.
The needs for resin lifetime studies, also called resin reuse studies, are well-known: they are a regulatory requirement, they ensure safety of the final biopharmaceutical product, and they improve process economy by using the full potential of your resin.
Lifetime studies are performed in a scale-down model of the chromatography step. They help validate the cleanability of the resin and ensure that it maintains an acceptable level of performance throughout its lifetime.
But these studies are quite tedious and lengthy. By outsourcing them, you can save both time and capacity. There are actually several other reasons why outsourcing resin lifetime studies can be beneficial. In this post we will cover the top five and their advantages.
1. Increase speed to market
Delays or failures in resin lifetime data generation means delays in NDA filing, which can be costly. Outsourcing resin reuse studies can increase your speed, as it gives you an extra pair of hands and access to more equipment and tools. This means that studies can be run in parallel to your other activities and you can get to market faster.
2. Access expertise
Outsourcing gives you access to specialized analytical tools and resin experts who know the resins, columns, and software inside and out. They can design and automate the studies, design optimal clean-in-place (CIP) protocols, prepare documentation for regulatory bodies, and much more.
Lifetime resin studies are not performed that often. So, even if you have trained staff available, it can be an advantage to outsource as you get access to resin experts who run these types of studies regularly.
3. Free up time
Resin lifetime studies are long. They can last up to 12 months, and you need both staff and equipment dedicated to the studies for the entire time. If you outsource, you can free up more than 1500* process development hours that can be dedicated to more value-added work. You can also use the downstream equipment for other purposes.
These studies are also very repetitive, which can make them a bit tedious. By outsourcing, you can make better use of your in-house skillsets and experience.
4. Free up CapEx
If someone else is performing your lifetime studies, you can free up capex to use on other projects. For example, you don’t have to invest in equipment dedicated to this purpose or specialized analytical equipment. Also, lab space can be tight. Instead of expanding to make room for more equipment—have the lifetime studies performed in someone else’s lab.
5. Minimize failures
It can be very costly to fail a resin lifetime study. In the worst case it can delay your NDA filing because the studies need to be repeated. This delays your market introduction and costs you both time and money.
Many things can lead to a failure. Some examples are contamination, improper chromatography column packing, high column pressures, dried up resins, or programming mistakes. With access to experts specialized in performing lifetime resin studies, you can minimize the risk of failures.
Save resources, capacity, and space
The benefits of outsourcing resin lifetime studies are many. With access to resin expertise specialized in this type of study, you can save resources, equipment capacity, and space.
To increase bioburden control and get the maximum value out of your resin, you can also outsource your CIP studies. That way, resin experts can design an appropriate CIP step that’s optimized for your resin. You will find out which cleaning agent works best and the optimal number of cleaning cycles. Optimizing the CIP step is also a safety issue as it helps minimize carryover.
*Data based on a 30-week study with 50 hours of labor per week.
Author: Mustafa Ege Ozturk:
Mustafa Ege Ozturk is a Lead Scientist at the Fast Trak Global Center of Excellence for Lifetime Studies. He has been designing and leading resin lifetime studies since he joined GE Healthcare Life Sciences in 2015. He works directly with customers to understand their unique needs and timelines for these studies.
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