June 29, 2021

Reducing errors and failures in biopharma drug substance production

Human errors and failures can be fatal and expensive, even more so when they occur in the medical and/or pharmaceutical fields.

However, it is not only human errors but also faulty equipment that can have enormous consequences for biopharmaceutical companies. If a batch is lost due to contamination – irrespective of whether it was caused by mishandling or faulty equipment, the manufacturer will likely suffer significant financial losses, but, even more fatally, this can lead to dire consequences for the patient relying on the specific medication.

And that is just one of the reasons why there are strict guidelines and regulations in place on how to deal with potential errors and the resulting impact on product quality or other consequences. Once an error report is issued, predefined corrective and preventative measures are to be implemented.

Analyzing and eradicating potential sources of errors and failures with advanced technology

A survey conducted in June 2020 showed that said deviations can be traced back to three major causes.


Source: Aspen Brook (preliminary results, June 2020)

The most effective way to deal with such issues is to eradicate potential sources by adapting the implemented technologies and systems so that interaction with humans can be reduced to a minimum, and at an even earlier stage, by implementing integrity tests that make sure your consumables are not faulty.

Agile and flexible systems on the basis of disposable single-use technologies

In recent years, technologies and platforms based on disposable single-use components have found their way from the lab – where they were initially employed – to mainstream production. An ever-growing number of pharmaceutical manufacturers is moving away from traditional tanks and implementing more flexible and user-friendly options:


Source: Aspen Brook (preliminary results, June 2020)

As an integral part of systems such as SEED.STREAM or the BULK.STREAM developed by SUSsupport, single-use technologies allow manufacturers a great level of flexibility and scalability when applying predefined actions during the nurturing of cells as well as the entire drug substance logistics process from filling to dispensing to shipping.

Standardized yet scalable solutions to eliminate potential sources of errors and failure

While the number of manufacturers employing manual filling processes is still surprisingly high, there is a growing trend towards utilizing more reliable automated systems.


Source: Aspen Brook (preliminary results, June 2020)

While being based on a standardized concept, the utilization of single-use components turns such systems into highly agile platforms that can be scaled to serve a number of purposes and basically any required volume. This is the perfect prerequisite for platforms that are used across the spectrum – from lab and study purposes all the way to small-scale and/or blockbuster production, offering the highest possible level of precision for both small batches and vast quantities.

It makes a big difference whether process steps such as seed train intensification, integrity testing, filtering or dispensing require human assistance or whether they can be fully automated in-line to take away a potential source for human error while at the same time increasing reliability and output.

Further advantages of process automation in biopharma

Additionally, automated processes on the basis of single-use technologies can reduce the risk of contamination by reducing or fully eliminating cleaning and maintenance.

It seems that the success of single-use technologies geared towards the biopharmaceutical sector is only logical to continue, given the long list of benefits they offer over traditionally used systems. If you want to find out how to streamline your processes with a scalable platform while at the same time reducing or eliminating potential sources for errors and failures, check out our Bulk.Stream process.

In other industries, the source „human error” is reduced by 30% to 60% using consistent process automation. Wow.


Michael Eder

Business Development / Marketing Manager