Clinical Genome Sequencing

Using Genome Sequencing to Ensure Drug Stability

Biologic drug development has the unique challenge of dealing with a live organism that has the ability to change. It’s a no brainer that pharmaceutical companies want to ensure that the biologic drug is stable throughout the manufacturing process to ensure that, once administered to a patient, it’s the same as they initially thought.

At the core of ensuring stability is something called bioprocessing. Bioprocessing is specific processes pharmaceutical companies use to get their biologic drug into the desirable state. Bioprocessing is broken down into two phases: upstream and downstream. Upstream in the bioprocess is typically cell isolation and cultivation. On the other end, downstream is usually broken up into 3 sections: cell disruption, purification, and polishing. After polishing, the biologic drug is then sent to packaging for distribution to the market.

Throughout that process, there are many steps where the biologic drug can start to change, or otherwise known as “genetic drift”. This unfavorable step can happen quite easily if the proper precautions aren’t taken. Normally, the bioprocess takes care of this and provides the right accuracy and precision needed to pass regulations. However, for more complicated biologics an additional level of guarantee of the drug’s stability is needed.

Many pharmaceutical companies are turning to genome sequencing, using it almost as an insurance policy for drug stability. Genome sequencing the biologic drug provides truth, in bulk, around the stability of the drug over time. For example, in the upstream portion of bioprocesses, pharmaceutical companies are using genome sequencing directly after the cell cultivation process to ensure that the cells are indeed what they are looking for. Companies use this as a drug stability leading indicator, refining their bioprocess even more.

The challenge with genome sequencing upstream is that to ensure genetic stability through this method, it really requires a larger population of samples. For example, it makes little sense to sequencing 1 sample of a biologic drug out of potentially 100’s or more due to potentially misleading evidence. In a typical environment, pharmaceutical companies will sequencing multiple samples at a time and even do multiple sequencing runs over time. By re-sequencing over time, it provides pharmaceutical companies the long term data showing how much or little the drug is stable for that duration.

Historically, this has been performed through ad-hoc sequencing runs which tend to be quite pricey. This is one of the core reasons why The Sequencing Center created a sequencing subscription model, allowing pharmaceutical companies to perform the same sequence many times throughout a year for a deeply discounted rate. Much like a cell phone data plan, the sequencing subscription has a set amount of sequences you can run each month. This provides clear, upfront, and non-variable pricing throughout the entire year.

Pharmaceutical companies are turning towards this type of mindset as the demands of regulation and drug stability increase within biologic drug development. By re-sequencing throughout the upstream process, these companies can gain peace of mind without breaking the bank. A sequencing subscription provides the perfect balance between price, scalability, and data generation.

 

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