Taking a Biopharmaceutical Process to the Next Level

Taking a Biopharmaceutical Manufacturing Process to the Next Level

Increasing production levels – and achieving this within a tight timeframe – can be a major challenge for biopharmaceutical manufacturers. 

Often, a bespoke bulk filling solution is required to achieve the manufacturer’s objectives.

Parker has the technical expertise, industry knowledge and products to assist manufacturers with this kind of complex challenge… and help their drug products reach the people that need them, in the quantities required.

Here’s an example… 

Increasing and accelerating production for a biopharmaceutical manufacturer 

A major biopharmaceutical manufacturer needed to rapidly increase vaccine production at its facility: the company required a bulk filter and dispense system that would have the capacity to fill a quantity of 250 x 10 L bottles every day, with a total of 1000 bottles to be filled per week.  

After the drug product was dispensed, the bottles needed to be taken on a conveyor belt and then bagged at the end of the line, ready for freezing. 

The number of bottles to be filled and the volume of drug product contained within them meant that manual handling would be impractical.

Recognizing that a bespoke solution would be needed for this manufacturing process, the manufacturer approached Parker.

Putting the right ingredients in place

The project process began with Parker partnering for the project with conveying and specialist handling equipment company Isoma. This collaboration combined Parker’s filter and dispense technology and expertise with Isoma’s experience in developing conveyor solutions.

The filter and dispense solution needed to be integrated with Isoma’s technology, without compromising its effectiveness and regulatory compliance.

Working closely with Isoma, we created a solution which combined filter and dispense system capabilities with the automation of the bagging process. Extensive testing was required to bring the joint project to a successful conclusion, so Parker and Isoma forged a synergistic relationship that drew on the respective strengths of both companies. Input from Parker’s specialist software team was also key to building an effective solution.   

What did the bespoke solution look like? 

While a two-stage approach to filter and dispense and bagging is common in bioprocessing, this would not have supported the level of production needed by the customer – therefore Parker and Isoma needed to ensure that both operations could be carried out seamlessly on one line.

Operator interaction was minimized within the process train by using many automated steps, such as bag crimping and sealing (which followed the dispense of the drug product), and auxillary steps such as labelling of each bottle - whereby a vision system incorporated into the line was used to ensure that the labels were applied in the correct orientation and the information on each label was correct and readable. 

As a fully automated system, the solution also protected operator safety – for instance by ensuring that heavy bottles did not need to be moved by hand – and minimized the risk of batch loss through mishandling – and with in-process feedback using SciLog single use sensors, the system was able to monitor and adjust, as well as stop the process should any irregularities have been detected. 

Human error was minimized by using an end user pre-defined recipe which was able to control all aspects of the system and eliminate variation which may have arisen if this was carried out manually. The automatic labelling was also able to accurately place the label in the defined location on each bottle, which would normally be difficult to control with human intervention. 

Parker was able to manufacture and supply a validated sterile single use flowpath – which incorporated both filtration and sensing technology to enable a seamless supply chain and robust and repeatable end to end processing solution. 

What was the end result? 

The collaborative partnership between Parker and Isoma was able to develop a system which was able to fill and eject each 10 Liter bottle in just over three minutes. This enabled the manufacturer to reach its production capacity targets.

There was also a significant saving in resource. 

A team of eight to 10 people would have been committed to working on the process if this bespoke, fully automated solution hadn’t been developed. In contrast, Parker and Isoma’s solution only required two people to run the full filter and dispense and bagging line, freeing up operators to work on more value added activities.  

In addition, the automated system was able to protect the manufacturer’s valuable drug product through minimizing human interaction and variability. 

This project demonstrated Parker’s ability to work in partnership with other specialists to create bespoke solutions for biopharmaceutical manufacturing. 

It also showed that when there is an urgent need to ramp up production and increase efficiency, and where the installation of an ‘off the shelf’ system can’t provide an effective solution, Parker can find a way forward…